A Feasibility and Acceptability Study of a Virtual Multimodal Intervention Delivered by Volunteers to Improve Functional Outcomes of Frail Older Adults Discharged From Hospital
Phase: NA
Conditions: Frailty, Malnutrition, Sedentary Behavior
Sponsor: University Hospital Southampton NHS Foundation Trust

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This protocol has regard for the HRA guidance and order of content 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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FULL/LONG TITLE OF THE STUDY 
A feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to 
improve functional outcomes of frail older adults discharged from hospital 
 
SHORT STUDY TITLE / ACRONYM 
Frail2Fit 
 
PROTOCOL VERSION NUMBER AND DATE 
Version 1.2 13/03/2024 
RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 
309521  
 
SPONSORS Number: 
RHM MED1860 
 
FUNDERS Number: 
GNT0525  
 
 
 

 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
...................................................................................................... 
 
 
Position: 
...................................................................................................... 
 
 
 
Chief Investigator: 
Signature:  
...................................................................................................... 
 
Date: 
13/06/2022 
Name: (please print): Dr Stephen Lim 
......................................................................................................
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
HRA PROTOCOL COMPLIANCE DECLARATION  
i 
TITLE PAGE  
ii 
RESEARCH REFERENCE NUMBERS 
 
ii 
SIGNATURE PAGE 
iii 
LIST OF CONTENTS  
iv 
KEY STUDY CONTACTS 
v - vi 
STUDY SUMMARY 
vii - ix 
FUNDING 
 
ix  
ROLE OF SPONSOR AND FUNDER 
ix - x 
ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS   
x - xii 
STUDY FLOW CHART 
 
xiii 
SECTION  
1. BACKGROUND 
 
1 - 4 
2. RATIONALE 
 
4 
3. THEORETICAL FRAMEWORK 
4 
4. RESEARCH QUESTION/AIM(S)  
4 - 5 
5. STUDY DESIGN/METHODS 
5 - 12 
6. STUDY SETTING 
13  
7. SAMPLE AND RECRUITMENT 
13 - 15 
8. ETHICAL AND REGULATORY COMPLIANCE 
15 - 20 
9. DISSEMINATION  POLICY 
20 - 21 
10. REFERENCES 
21 - 24 
11. APPENDICES 
25 - 99 
 
 

 
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KEY STUDY CONTACTS 
Chief Investigator 
Dr Stephen Lim 
Consultant Geriatrician 
Clinical Academic in Geriatric Medicine 
Academic Geriatric Medicine 
University of Southampton 
University Hospital Southampton NHS FT 
Tremona Road 
Southampton 
SO16 6YD  
 
Email: s.e.lim@soton.ac.uk 
Telephone: 02381206131 
Sponsor 
University Hospital Southampton NHS Foundation Trust 
sponsor@uhs.nhs.uk 
Funder(s) 
University Hospital Southampton NHS Foundation Trust 
Small Grant Scheme 
Email: researchgrants@uhs.nhs.uk  
 
UHS Grant Reference Number: GNT0525 
Key Protocol Contributors 
Professor Helen Roberts  
Professor of Medicine for Older People,  
Academic Geriatric Medicine 
University of Southampton,  
University Hospital Southampton NHS FT 
Southampton SO16 6YD 
Email: h.c.roberts@soton.ac.uk 
Telephone: 02381 204354 
 
Professor Mike Grocott 
Professor of Anaesthesia & Critical Care 
Clinical and Experimental Science 
University of Southampton 
University Hospital Southampton NHS FT 
Southampton SO16 6YD 
Email: mike.grocott@soton.ac.uk  
Telephone: 02381 208449 
 
Professor Sandy Jack 
Consultant Clinical Scientist in Anaesthesia and Critical 
Care  
University Hospital Southampton NHS FT 
Email: s.jack@soton.ac.uk  
 
Professor Jane Murphy 
Professor of Nutrition 
Faculty of Health and Social Sciences 
Ageing and Dementia Research Centre – CoDirector 
Bournemouth University 

 
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Bournemouth Gateway Building. 
St. Pauls Lane, Bournemouth, BH8 8GP 
Email: jmurphy@bournemouth.ac.uk 
Telephone: 07872 048915 
 
Dr Judit Varkonyi-Sepp  
Chartered Psychologist 
Manager Behavioural Science Theme 
NIHR Biomedical Research Centre 
Clinical and Experimental Science 
University of Southampton 
Email: j.varkonyi-sepp@soton.ac.uk 
 
Mr Andrew Bates 
Clinical Academic Intensive Care Nurse and Critical Care 
Research Manager, Fit4Surgery portfolio 
University Hospital Southampton NHS FT 
Email: a.bates@soton.ac.uk  
Telephone: 07917208867 
 
Dr Chloe Grimmett 
Senior Research Fellow for Macmillan Survivorship 
Research Group  
University Hospital Southampton NHS FT 
Email: c.grimmett@soton.ac.uk  
Telephone: 02380 597964 
 
Mrs Cynthia Russell 
Public patient representative 
Email: cynthia.russell@btinternet.com  
 
Dr Samantha Jane Meredith 
Research Fellow 
Academic Geriatric Medicine 
University of Southampton,  
University Hospital Southampton NHS FT 
Southampton SO16 6YD 
Email: s.j.meredith@soton.ac.uk 
Telephone: 07825 104783 
 
 
 
STUDY SUMMARY 
 
Study Title 
A feasibility and acceptability study of a virtual multimodal 
intervention delivered by volunteers to improve functional 
outcomes of frail older adults discharged from hospital 

 
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Internal ref. no. (or short title) 
Frail2Fit 
Background 
Between 30-60% of older people in hospital lose muscle 
strength and function (deconditioning) which reduces quality of 
life and increases their risk of hospital readmission. Physical 
inactivity is estimated to cost the NHS about £1 billion per year. 
This can be improved with increasing physical activity and 
good nutrition. Our team have developed and evaluated a 
programme using online clinics to successfully support over 
600 cancer patients living at home to stay active and eat well 
with provision of emotional support (SafeFit study). With many 
older people now using the internet for social connection, we 
have an opportunity to investigate whether a similar model can 
improve the health of older people.  
Research Question/Aim(s) 
 
Frail2Fit will explore the feasibility of training volunteers to 
deliver online nutrition, exercise, and behaviour change 
(supported self-management) to improve the health of older 
people after discharge from hospital. We also want to know if 
this supported self-management is acceptable to older people, 
their family members and/or carers, and the volunteers.  
Study Design & Methods 
In this mixed methods feasibility study, older adults in hospital 
and identified as frail, will be recruited from medical wards. 
Volunteers will be trained using our established methods to 
support patients to be physically active and eat well. 
Techniques to support behaviour change will help patients 
engage with the programme. Volunteers will meet the 
participants online over a 12-week period. We will report the 
number of volunteers recruited, trained, and retained. We will 
also report the number of patients recruited, adherence to the 
intervention, and any adverse events. To evaluate the benefit 
of the intervention we will measure participants’ physical 
function, appetite, quality of life and well-being, and the impact 
on hospital admissions. To explore experiences and views 
about the intervention we will interview 15 patients and their 
family member/carers, and 10 volunteers.  
Study Participants 
Older adults discharged from hospital will be invited to 
participate in this study. The inclusion criteria are older adults 
age 65 years and above who are able to provide written 
consent and have been discharged from UHS, who are 
identified as frail (Clinical Frailty Scale ≥5) and are able to 
walk at least a few steps upon hospital discharge. Older 
adults who are not able to safely complete the exercises 
included in the intervention, and patients who are discharged 
to rehabilitation units, or care homes, or patients receiving 
end of life care, will be excluded from the study. 
 
Volunteers from UHS patient support hub will be invited to 
participate in this study to deliver the Frail2Fit intervention. 
The inclusion criteria are volunteers aged 16 years and 

 
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above, who have completed the generic clearance and 
training at UHS, who can provide written informed consent, 
and are able to communicate fluently enough in English. 
Volunteers that are unable to safely complete the exercises 
included in the intervention will be excluded from the study. 
Planned Size of Sample (if applicable) A sample size of 23 patients was chosen in line with previous 
sample size recommendations for feasibility studies of 12-50 
participants.  This sample size was considered an appropriate 
number that is pragmatic and achievable within the study 
timescale and resources available.  
 
A sample size of 6 volunteers was chosen to provide 
sufficient cover to deliver the Frail2Fit intervention to groups 
of 5-6 older adults with 2 volunteers supporting each group.  
Outcomes  
Primary outcomes: Feasibility and acceptability  
 
Secondary outcomes: physical activity levels (PASE and 
GENEActiv), physical function (Barthel Index), appetite 
(SNAQ), well-being (WEMWBS), anxiety and depression 
(HADS), and self-efficacy for managing chronic disease. 
Patient and Public Involvement 
We surveyed 92 older adults in the community and care 
homes. 45% had experience working with volunteers and 
appreciated their contribution. Our SoMoVe study showed that 
volunteer-led physical activity intervention in hospital was well 
received by older adults, and they also enjoyed the social 
interaction. In our survey in 2020, 47 out of 50 older adults 
attending social clubs agreed or strongly agreed to have 
trained volunteers lead exercises. 2 public contributors 
provided input into this study proposal. They will be invited to 
join the study management group and be involved from 
development to dissemination of study findings.  
Dissemination 
We will develop a toolkit to support knowledge transfer 
including advice on volunteer recruitment, training, and 
suggestions for successful implementation. Results will be 
shared with commissioning services, NHS staff, volunteer 
organisations and service users via charities e.g. Age UK, 
supported by our PPI partners. Results will also be shared via 
publication and conference presentations. 
 
Planned Study Period 
Start Date: 01/06/22 
End Date: 31/07/23 
Years: 1 Months: 1 Days: 30 
 
 
FUNDING AND SUPPORT IN KIND 

 
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FUNDER(S) 
(Names and contact details of ALL organisations 
providing funding and/or support in kind for this 
study) 
FINANCIAL AND NON FINANCIALSUPPORT 
GIVEN 
University Hospital Southampton NHS 
Foundation Trust 
R&D Department, Southampton General 
Hospital 
Level E, Laboratory & Pathology Block, SCBR - 
MP138 
Southampton 
SO16 6YD 
researchgrants@uhs.nhs.uk 
Funding secured: £51,019 
Duration: 1 year, 4 months 
 
 
ROLE OF STUDY SPONSOR AND FUNDER 
The sponsor will take overall responsibility for proportionate, effective arrangements being in place to 
set up, run and report the research project. The study sponsor will review research protocols and 
study documents to ensure they meet regulatory requirements. The sponsor will also review IRAS 
forms before submission for ethical review and will monitor the conduct of the study, including any 
amendments that need to be made. The sponsor will review annual progress reports and will be 
involved in the ‘close out’ of the study.  
 
Funding for this study is provided through the University Hospital Southampton NHS FT Small Grants 
scheme. The study funder reviewed the protocol before funding was secured to ensure the proposed 
project aligned with research portfolios within UHS clinical divisions, and/or the UHS/UoS research 
infrastructure. The funder has provided funding to cover the costs of the study, detailed below:  
 
Summary of costs 
Research Fellow  
 
 
£31729 
Tablets and sim card  
 
£6000 
Post and packaging  
 
£400  
Travel expenses 
 
 
£240 
Conferences  
 
 
£500 
PPI cost 
 
 
 
£2000 
Open Access publication 
 
£1500 
Telephone calls 
 
 
£200 
Interview transcription 
 
£400 
Volunteer expenses  
 
£7500 
UHS R&D fees 
 
 
£550 
Total  
 
 
 
£51019 
 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS 
 
The Principal Investigator (PI), Dr Stephen Lim is responsible for the overall conduct of the study. He 
has the primary responsibilities of planning and managing the project, ensuring that the project 
progresses according to schedule.  
 

 
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Prof Helen Roberts, who is a Professor of Medicine for Older People, is a senior academic who has 
vast experience in research among older people. She will contribute and support the PI with her 
expertise in the management of the study and with her previous experience of working with 
volunteers.  
 
Andrew Bates has extensive experience managing clinical trials which aim to optimise patient’s 
metabolic and psychological well-being. Andrew will be involved in the training of volunteers, including 
competency assessment. He will support the research fellow in developing the training manual and 
delivering the training for the volunteers and research participants. He will ensure that the study is 
conducted to time and target, consistent with the highest principles of clinical, data and trial 
governance. 
 
Dr Chloe Grimmett is a post-doctoral research fellow with research interests in the development of 
interventions to support self-management, and in psychological and physical optimisation of patients. 
She is the lead behavioural scientist for the WesFit and SafeFit trials. She will deliver the behavioural 
change support training for the volunteers. 
 
Professor Sandy Jack is a Consultant Clinical Scientist in Anaesthesia and Critical Care, and has 
vast research experience and expertise in the development and implementation of exercise 
interventions. Her expertise will be key to the delivery of a robust physical activity intervention. Her 
experience in conducting trials will ensure that the study will be conducted to a high standard.  
 
Prof Jane Murphy has a wealth of experience in nutrition and ageing research. Her expertise will 
ensure that the nutritional aspects of the intervention are robust. She will also support the delivery of 
the intervention working within University Hospitals Dorset. 
 
Dr Judit Varkonyi-Sepp is Manager for the Behavioural Science Theme at NIHR Biomedical 
Research Centre (BRC) and a Health Psychologist, Research Psychologist and Coaching 
Psychologist. Her expertise will ensure the behaviour change aspects of the intervention is robust. 
She will also support the delivery of the volunteer’s behaviour change training. 
 
A research fellow will assist the PI in participant recruitment, data collection and data entry. Weekly 
meetings will be held with the PI and the research fellow to discuss the day to day running of the 
study. Monthly project management meetings will be held with the PI, RF and PPI lead to discuss the 
progress of the study and to monitor the conduct of the study. 
 
Patient and public involvement (PPI) 
We surveyed 92 older adults in the community and care homes. 45% had experience working with 
volunteers and appreciated their contribution. Our SoMoVe study showed that volunteer-led physical 
activity intervention in hospital was well received by older adults and they also enjoyed the social 
interaction. In our survey in 2020, 47 out of 50 older adults attending social clubs agreed or strongly 
agreed to have trained volunteers lead exercises. 2 public contributors provided input into this study 
proposal. They will be invited to join the study management group and be involved from development 
to dissemination of study findings.  
 
In this study, the role of PPI includes: 
 
• 
Reviewing patient-facing materials such as patient information sheet, consent form forms and 
questionnaires. 
• 
Participating in the study steering group to support the delivery of the study. 

 
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• 
Providing input at every stage of the study to ensure that the focus of the study is primarily on 
delivering patient benefit. 
• 
Ensuring that the processes of the study such as data collection, and interviews, are not too 
burdensome for patients. 
• 
Recommending methods or avenues of disseminating research findings to provide a wider 
reach and ensure that patient and the public are informed of the research findings.  
 
 

 
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PROTOCOL CONTRIBUTORS 
The current protocol has been developed and adapted from the SafeFit trial, SoMoVe and ImPACt 
studies, steering study procedures and providing an evidence-based training package for volunteers. 
Public representatives have been involved in the design of the multi-modal volunteer-led intervention 
and will critique any patient-facing resources, such as participant information sheets, consent forms 
and training manuals.  
 
The study sponsor (UHS) and funders (UHS Small Grants Scheme) were not directly involved in the 
design of this study. They will review research protocols and study documents to ensure they meet 
regulatory requirements. This provides the R&D Office with information on the considerations which 
have been made in the development of the protocol in a number of areas to help assess the level of 
risk to the Trust and how this can be mitigated. The sponsor will also review IRAS forms before 
submission for ethical review and will monitor the conduct of the study, including any amendments that 
need to be made. The sponsor will review annual progress reports and will be involved in the ‘close 
out’ of the study.  
 
The study funder reviewed the protocol before funding was secured in order to ensure the proposed 
project aligned with research portfolios within UHS clinical divisions, and/or the UHS/UoS research 
infrastructure.  
 
KEY WORDS:  
Frailty; older adults; volunteer-led exercise; nutrition 
support; behaviour change; online intervention  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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STUDY FLOW CHART 
 
Frail older adults on acute medical wards 
identified by the clinical care team 
Interested participants approached by 
research team to complete screening 
checks for eligibility 
Informed consent 
Completion of baseline questionnaires 
Volunteers identified by UHS voluntary services 
Volunteer training 
Month 1: 3 group sessions per week with 
volunteer 
Month 2: 2 group sessions per week with 
volunteer 
Month 3: 1 group session per week with 
volunteer & completion of questionnaires 
at end of intervention 
Month 6: Follow-up questionnaires 
Delivery of multi-modal 
online intervention 
Month 1 – 6: Completion 
of interviews  

 
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STUDY PROTOCOL 
A feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to 
improve functional outcomes of frail older adults discharged from hospital 
 
1 
BACKGROUND 
Older people with frailty are at high risk of poor outcomes including increased post-hospitalisation, 
healthcare use and mortality [1]. Frailty refers to a state of vulnerability to poor resolution of 
homeostasis after a stressor event and results from a cumulative decline in biological reserves across 
multiple organ systems [2]. Approximately 11% of community dwelling older adults have frailty [3], 
compared to around 14% prevalence in English hospitals [4]. As frailty progresses older adult’s 
functional status declines, resulting in disability, increased risk of falls, and long-term care [5]. 
Moreover, deconditioning during hospital admission is a major concern and impacts significantly on 
older adult’s ability to be independent. Hospitalised older adults are at risk of immobilisation resulting 
in reductions in muscle mass by 0.5% and muscle strength by 0.3-4.2% per day [6, 7]. Considering 
these detrimental clinical consequences, identifying vulnerable patients with frailty, and intervening to 
prevent functional decline is a high-priority patient-centred outcome.  
 
Current evidence suggest that physical activity (PA) and nutrition interventions are key to maintaining 
independence and improving frailty status among pre-frail and frail older adults [8, 9]. Physical activity 
is defined as any bodily movement produced by the musculoskeletal system that increases energy 
expenditure, and exercise is a sub-category of PA which aims to improve or maintain one or more 
components of physical fitness through planned, structured, repetitive, and purposive programming 
[10]. PA and exercise are key strategies to preserve or improve the function of multiple physiological 
systems that are affected by age, including the respiratory, endocrine, cardiovascular and skeletal 
muscle systems [11]. Maintenance of regular PA supports older adult’s ability to remain independent 
in activities of daily living (ADL), such as bathing, dressing, and mobilising, and promotes 
independence and quality of life [12]. PA and nutrition have also been advocated as important lifestyle 
behaviours to combat and prevent frailty progression during infection prevention measures, helping to 
alleviate risks associated with social isolation, malnutrition, reduced access to care, and increased 
sedentary time during the pandemic [13]. Low PA levels and increased time spent being sedentary 
increases older adults’ risk of frailty [14]. Hence, public health initiatives, and healthcare professionals 
are concerned with the promotion of PA and the consideration of the appropriate type, effectiveness, 
and feasibility of PA interventions to implement in practice [15, 16].  
 
General PA guidelines for older adults age ≥65 years recommend completion of at least 150-300 
minutes of moderate-intensity aerobic PA each week (or at least 75-150 minutes of vigorous-intensity 
PA), and functional balance and muscle-strengthening activities at least three times per week, for 
health benefits [16]. For older adults with frailty a multicomponent exercise intervention including 
flexibility, balance, power, strength, and aerobic training is recommended across frailty categories [15, 
17, 18]. As patients become more frail, increased strength training has been advocated to improve 
functional status and reduce further decline, increasing exercise intensity as frailty status improves 
[17]. In a recent meta-analysis, Lopez et al. [18] found that progressive strength training alone or 
combined with other training components were effective intervention strategies for increasing physical 
aspects of frailty, including maximum strength of knee extensors (SMD 1.07, 95% CI – 0.56 to 1.58, I² 
92%, p<0.001), gait speed (SMD 1.57, 95% CI – 0.50 to 2.64, I² 95%, p<0.001), and timed-up-and-go 
(SMD -0.91, 95% CI – -1.45 to -0.36, I² 90%, p≤0.001). In other research, moderate-vigorous PA 
assessed via accelerometers helped to reduce frailty levels in older adults, while light PA attenuated 
frailty in older adults with co-morbidities, highlighting the need to tailor PA volume to suit older adult’s 

 
 
 
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individual needs [19]. However, PA is only one part of the holistic health and broad-based approaches 
recommended within frailty consensus statements, with existing literature recognising optimal nutrition 
as a key strategy to augment PA benefits [20]. 
 
Malnutrition is common in older adults and is closely associated with frailty, playing a key role in its 
pathogenesis [21]. According to the European Society for Clinical Nutrition and Metabolism (ESPEN) 
malnutrition refers to ‘a state resulting from a lack of uptake or intake of nutrition leading to altered 
body composition (decreased fat free mass and body cell mass) leading to diminished physical and 
mental function and impaired outcome from disease’ [22]. In a meta-analysis exploring nutritional 
status in older adults across healthcare settings, malnutrition was present in 3% among community-
dwelling older adults, 8.7% among older people receiving home care services, and 6% among those 
attending outpatients [23]. The quality of older adult’s diet has a close relation with the incidence of 
frailty [24]. Dorner et al. [25] examined the associations between nutritional status and frailty in acute 
hospitalised patients and found 76.7% had malnutrition or were at risk of malnutrition. Moreover, 
findings illustrated that three-quarters of malnourished hospitalised older adults were frail and over 
90% of malnourished participants were pre-frail or frail. Considering the prevalence of malnutrition in 
older people, its close association with frailty and the negative health outcomes linked to these 
conditions (e.g., increased morbidity and mortality), more attention is needed in discharge 
management and continuity of care between the hospital setting and post-discharge setting with 
improved nutritional care management and intervention [25-27]. 
 
The causes of malnutrition are multifactorial and therefore a range of practical approaches in the 
management of malnutrition among frail older people are needed [27]. The ESPEN guideline on 
clinical nutrition in older people provides evidence-based recommendations in the prevention and 
treatment of malnutrition and advocates that all older people should be routinely screened for 
malnutrition to identify an existing risk early [28]. Oral nutrition can be supported by nursing 
interventions, education, nutritional counselling, food modification and oral nutritional supplements 
[28]. Moreover, a burgeoning area of research pinpoints the need to routinely assess appetite to 
prevent unintentional weight loss among older people, in which the effects of ageing on appetite can 
drive older people towards a state of reduced hunger with negative links to malnutrition and frailty [29, 
30]. Recent development in the Patients Association Nutrition Checklist (PANC) has been used for the 
early identification of malnutrition risk attributed to unintentional weight loss and appetite changes, 
together with signposting to basic dietary advice and appropriate health and social care support in 
community-dwelling older adults [31]. Upon discharge, the tool can be used easily within a ‘Nutrition 
Wheel’ format by key stakeholders including volunteers and community workers to encourage 
conversations with frail older adults regarding malnutrition and to provide sources of help for those 
likely to be at risk [32].      
 
Interventions to identify malnutrition and improve nutrition status, and to enhance PA levels, have 
been implemented across a range of settings [17, 27]. However, with the restrictions on social 
activities and social distancing rules, there is an increasing need to explore innovative ways to deliver 
supportive self-management interventions that encourage older people to eat well and be physically 
active. In response to the COVID-19 restrictions, healthcare and rehabilitation have increasingly 
turned to virtual modes of delivery, such as telehealth methods [33]. The increasing use of technology 
in the daily lives of many allows PA and nutrition interventions to be delivered online [34]. For 
instance, the SafeFit trial has successfully trained over 40 non-healthcare exercise professionals to 
deliver an online universal intervention to maintain and improve physical, nutritional, and psychological 
well-being in vulnerable people with cancer, who are following social distance guidance [35]. This trial 
was developed in collaboration with Macmillan Cancer Support, CanRehab trust and Wessex Cancer 

 
 
 
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Alliance. The intervention is consistent with NHS England Long-term plan to promote personalised 
care and supported self-management. In other research, telephone conversations, tele-monitoring 
devices, and internet-enabled tablets have also been shown as an effective means to deliver nutrition 
and PA interventions to older adults [36, 37]. Yamada et al. [38] investigated a combined nutrition and 
PA intervention through remote delivery for older adults with sarcopenia. Notably, they found that a 
remote programme of pedometer -based walking and nutritional supplementation (protein and vitamin 
D) delivered over 6 months enhanced anabolic hormone levels, step count, and skeletal muscle mass 
index in community-dwelling older adults with frailty. Hence, exploring the feasibility, acceptability and 
effectiveness of multi-modal telehealth interventions for older adults with frailty is an important 
research agenda and existing literature indicates the important utility of such delivery modes and 
interventions within the current health climate to improve routine practice and continued care of older 
adults with frailty.  
 
In addition to remote online interventions, there is also increased attention towards volunteer-led 
implementation of PA and nutrition strategies [39-41]. Delivery of interventions in the community by 
healthcare professionals, dieticians, or exercise trainers may have cost implications. One alternative 
would be to train volunteers to deliver multi-modal interventions in the community. Volunteering can be 
defined as an activity that is freely chosen, does not involve remuneration and helps or benefits those 
beyond an individual’s immediate family. Rather than a spontaneous help given to someone in an 
emergency situation, volunteering is typically proactive rather than reactive and entails some 
commitment of time and effort [42]. In the Kings Fund report on volunteering in health and care in 
England, the most common settings for volunteer support were hospices, community settings and 
hospitals [43]. A recent systematic review explored the impact of PA interventions conducted by 
trained volunteers on health-related outcomes for community-dwelling older people age ≥65 years 
[39]. Trained volunteers implemented strength and balance exercises 1-3 times per week, which led to 
improvements in functional status (e.g., short physical performance battery, Barthel Index), improved 
frailty status, a reduction in fear of falls, and maintained or improved quality of life [39]. Nevertheless, 
the review called for more high-quality research to investigate the effects of volunteer-led PA 
interventions among older people. Similarly, a systematic review and meta-analysis investigating the 
effectiveness of trained volunteers delivering interventions to individuals at risk of malnutrition 
highlighted significant improvements in physical performance, fear of falling, lunchtime energy intake 
and improved patient satisfaction across community and hospital settings [40]. Yet, the findings were 
based upon low quality evidence and thus the authors recommended more adequately powered 
research in the area to identify the most effective use of resources to combat malnutrition and frailty. 
 
Recently, the SoMoVe study trained volunteers to deliver PA interventions for hospitalised older 
people on acute medical wards [44]. The study found that it was feasible to deliver a volunteer-led 
mobility intervention including the recruitment, training and retention of volunteers. The intervention 
was safe and acceptable to healthcare professionals and patients, and a commonly cited benefit was 
the social aspect of the intervention, in which volunteers developed a rapport with patients and 
encouraged them to mobilise or exercise. Nevertheless, reported key barriers identified included the 
busy clinical environment and lack of awareness of the intervention among staff. Volunteers have also 
been shown to reduce frailty and malnutrition risk among community-dwelling older adults [41, 45]. For 
example, in a randomised controlled trial Luger et al. [41] found that volunteers trained to perform 
nutrition-related discussions and strength exercises with older adults, resulted in a 25% reduction in 
prevalence of impaired nutritional status and an improvement in frailty status. Furthermore, an array of 
existing research has shown improvements in handgrip strength, quality of life, social participation, 
physical function and frailty status in community-dwelling pre-frail and frail older adults receiving 
home-based PA and nutrition interventions from lay-volunteers [45-47]. Consequently, a whole society 

 
 
 
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approach involving multi-sectoral collaborations, such as community volunteers, has been advocated 
to promote age-friendly communities and healthy ageing [47]. 
 
2 
RATIONALE  
There is strong evidence regarding the health benefits of PA and nutrition to improve frailty for older 
adults, yet COVID-19 restrictions have presented significant challenges to older adult’s lifestyle 
behaviours and for the effective delivery of routine healthcare and rehabilitation. Early research 
indicates that volunteer led interventions are potentially feasible and can have positive effects on older 
adult’s health and physical functioning, yet more research is needed to further explore the 
acceptability, feasibility, and effectiveness of this approach. Building on these studies, the current 
research will evaluate a multi-modal online volunteer-led nutrition support and PA intervention for older 
people with frailty, post-hospitalisation. To our knowledge there are currently no studies exploring the 
use of trained volunteers delivering such interventions online, thus more research is needed to identify 
the facilitators and barriers of volunteer-led online interventions for frail older people. 
 
3 
THEORETICAL FRAMEWORK 
In this study, Normalisation Process Theory (NPT) will be used as the theoretical framework which will 
underpin the development and evaluation of the volunteer-led intervention [48]. The NPT provides a set of 
sociological tools to understand and explain the social processes through which new or modified practice 
of thinking, enacting, and organizing work are operationalized in healthcare and other institutional 
settings. The use of an implementation theory is useful as it helps researchers identify, describe and 
explain important elements of the implementation process. The three core problems which the theory is 
concerned with are: implementation (bringing of a practice or practices into action), embedding (routine 
incorporation of practice or practices into everyday work of individuals and groups) and integration 
(reproduction and sustainability of a practice or practices among the social matrices of an organization or 
institution). NPT was used in the development of the study protocol as well as the online physical activity 
and nutrition intervention. The online NPT toolkit was used to assist in critically thinking through the 
processes and challenges which may arise in implementing and integrating an intervention in a complex 
health care setting.  NPT was chosen as the framework that underpinned this study as it was systematic 
in its approach, easy to understand and provided a proven framework to evaluate the implementation 
process of this study. The online toolkit available for this implementation theory also made the application 
of NPT at various stages of this study more convenient and practical. 
 
4 
RESEARCH QUESTION/AIM(S) 
This study aims to explore the feasibility and acceptability of training hospital volunteers to deliver an 
online multi-modal intervention, including exercise, behaviour change and nutrition support, to older 
people with frailty discharged from hospital.  
 
4.1 
Objectives 
 
The specific objectives include:  
1. To develop a training programme for volunteers to support the delivery of an online 
multimodal intervention.  
2. To assess the feasibility of recruiting, training and retaining volunteers to deliver the 
intervention. 
3. To assess the feasibility of recruiting and retaining older adults with frailty to the trial. 

 
 
 
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4. To determine the acceptability of the intervention and explore barriers and facilitators to the 
intervention to support future wider implementation. 
 
4.2 
Outcome 
Exploration of the feasibility and acceptability of the intervention will help to determine whether the 
multi-modal volunteer-led online intervention is appropriate for further evaluation in future research, to 
determine sample sizes for a controlled trial and to assess whether the ideas and findings can be 
shaped to be relevant and sustainable. The study will also help to determine suitability of the 
intervention for a larger roll out of the programme across Wessex. 
 
Through collaborations between University of Southampton, University Hospital Southampton, and 
Wessex AHSN, the anticipated impacts include: 
 
• 
Development of training material for wider use and future implementation studies. 
• 
Collaboration with Wessex AHSN and the National Association of Voluntary Services Manager 
to develop an implementation plan with the aim to roll out the intervention across the 
Hampshire and Isle of Wight region and nationally at a later stage. 
• 
Dissemination of our research findings through scientific and lay platforms to encourage 
implementation in other settings. 
• 
Increased participation in PA and improved nutrition support for frail older people post-
discharge with potential benefit in health outcomes. 
 
5 
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS 
 
Study Design 
A quasi-experimental mixed methods approach will be used to determine the feasibility and acceptability 
of implementing a volunteer-led multi-modal intervention for discharged older adults with frailty. This 
feasibility study will be conducted at the University Hospital Southampton NHS Foundation Trust (UHS), 
training hospital volunteers to deliver virtual group support for older adults discharged from UHS. 
 
Feasibility studies are used to determine whether an intervention is appropriate for further evaluation, 
to determine sample sizes for controlled trials and to assess whether the ideas and findings can be 
shaped to be relevant and sustainable. In this study, the feasibility of training volunteers to deliver a 
virtual multi-modal intervention to improve older adult’s functional outcome post-discharge will be 
assessed. The acceptability of the intervention will also be examined through qualitative interviews to 
explore the views and experiences of volunteers, trainers, carers and older adults involved in this 
study. The impact of the intervention on physical activity levels and functional outcomes will be 
measured. However, as this is a feasibility study, it is not powered to show any statistical difference in 
the outcome measure. 
 
Intervention 
The intervention duration will be 3 months. Participants will receive three group sessions per week for 
1 month (weeks 1-4), twice per week for the second month (weeks 5-8), and once weekly for the last 
month (weeks 9-12), with a maximum of 24 sessions. The tapered nature of the intervention was 
chosen to provide suitable support for older adults post-discharge with the aim to gradually encourage 
increased self-management to foster independence post-intervention. Components of the intervention, 
including exercise, nutrition support and behaviour change support, will be delivered from an online 
platform (Zoom). Each group session will last 40-60 minutes, including 20-30 minutes of exercise 

 
 
 
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followed by 20-30 minutes of nutrition support. The components of the intervention and the training 
package have been adapted from the SafeFit trial [35] and will be delivered in line with behaviour 
change principles and emotional support to maximise participant uptake, adherence and lifestyle self-
management.  
 
Exercise: The exercise will consist of volunteer-led group progressive resistance exercise training for 
20-30 minutes. To align with home-based safety considerations, the exercises will be performed 
seated. Seated exercise will focus on strengthening upper and lower limbs (8 major muscle groups) 
and enhancing whole body range of motion and flexibility, tailored specifically to meet the needs of 
older adults and to minimise the risks of injury. Participants will be encouraged by the volunteers to 
progress repetitions (aiming for 3 sets of 8 repetitions) and to gently improve range of motion. Elastic 
resistance bands will be introduced from Week 5 to older adults who are comfortable and ready to 
progress to using resistance in the exercises. Participants will be encouraged by the volunteers to 
increase the resistance grade if they are able to carry out the repetitions easily. Intensity will be 
monitored with the Resistance Intensity Scale for Exercise (RISE) [49] and the Talk Test [50], aiming 
for a low-moderate difficulty on RISE and 4-6 on the Talk Test. Participants will be encouraged to 
complete the exercises 2-3 times per week consistent with Chief Medical Office guidelines on PA and 
strength improvement for older adults [16]. The exercise programme has been developed and piloted 
from a previous ARC Wessex study that aimed to improve PA and health in community-dwelling older 
adults through trained volunteers [51]. Participants will be given an exercise booklet and access to an 
exercise video to help support engagement with the exercises and encourage un-supervised 
participation at home.   
 
Nutrition support: Volunteers will work with participants to review their diet and eating habits using 
the Nutrition Wheel to ensure their nutrition is appropriate and they are not at risk of undernutrition 
[31]. The Nutrition Wheel is an interactive tool developed from the Patients Association Nutrition 
Checklist (PANC) and used to engage individuals in conversation about unintentional weight loss and 
malnutrition. The Nutrition Wheel was developed by Professor Murphy in collaboration with the 
Wessex AHSN and key stakeholders and charities and identifies whether an older adult may be at risk 
of undernutrition, providing guidance accordingly. Specifically, the Nutrition Wheel consists of 4 main 
questions from PANC, including 1) Are you or your family concerned that you may be underweight, or 
need nutritional advise? 2) Have you lost a lot of weight unintentionally in the past 3-6 months? 3) 
Have you noticed that your clothes or rings have become loose recently? 4) Have you recently lost 
your appetite and/or your interest in eating? Based on the participant’s answers, they will be directed 
to further questions and guided to appropriate nutritional advise. Individuals identified as 
undernourished will be signposted to appropriate information sheets, national helplines, or if 
necessary, signposted to their GP/practice nurse for further advise and screening. 
 
Behaviour change support: Volunteers will receive training in healthy conversation skills (HCS) 
guided by principles of Making Every Contact Count (MECC) [52, 53]. The MECC approach supports 
positive behaviour change through encouraging client-centred brief conversations surrounding health 
and well-being and will help support the delivery of the exercise and nutrition components in the 
current intervention. Training will enable volunteers to have the confidence and competence to deliver 
healthy lifestyle messages, to help encourage participants to change their behaviour through solution-
focused and empowering approaches [54]. The MECC approach is underpinned by behaviour change 
principles from the COM-B model, highlighting both automatic and reflective processes involved in 
decision making and action. Through using HCS in the current intervention volunteers can help to 
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participants to take control of their health behaviours by building self-efficacy and a sense of control 
[55].  
 
Participants will be given the option to choose between the online intervention and telephone 
consultations. Participants who opt for telephone consultations will be encouraged by volunteers to 
perform the exercises provided in the booklet and will be given nutritional advice based on the nutrition 
wheel. The frequency of telephone consultations will be similar to the online intervention. 
 
Training of volunteers 
Volunteers will receive a bespoke training package adapted from the SafeFit training guidance [35]. 
Depending upon current Government recommendations in response to the COVID-19 pandemic the 
training will either be delivered online by the research team, or in-person at UHS. Once the 3 training 
components (i.e., exercise, nutrition, and behaviour change) have been completed, volunteers will 
support and shadow the trainers to deliver the intervention during the first month, aiming for 2 
sessions per week to be delivered by the trainers and 1 to be delivered by the volunteers with support 
from the trainer. After 4 weeks, volunteers will be expected to lead the sessions independently to 
continue supporting participants in the adherence of the intervention with continued weekly input by 
the trainers. 
 
Exercise: The exercise training programme will be developed based on clinical expertise from 
therapists and current evidence including experience from a recently completed study [44] and an 
ongoing feasibility study [51]. Training will include 2 group sessions each lasting approximately 2 
hours. The first training session will include a brief section teaching the theory underpinning the 
benefits of exercise for older adults, and will include exercise training principles, such as FITT 
recommendations (frequency; intensity; time; type). The remainder of the first training session will give 
an overview of the seated exercise content, detail exercise delivery advice (e.g., how to demonstrate 
and give effective teaching points), and explore exercise safety considerations (e.g., safe set-up 
before and during exercise, and what to do in an emergency). Volunteers will be given an exercise 
training manual and links to a video to practice the exercises in their own time. Time for practice (1-2 
weeks) will be given before volunteers return for their second group exercise training session. The 
second session will focus on delivery of the seated exercises allowing volunteers to practice delivering 
the exercise to their peers and to obtain feedback from the group and trainer. Safety considerations 
will be revisited at the end of the second session. Volunteers will also receive training on how to 
document adverse events that occur during the exercise classes. 
 
Following completion of group exercise training, volunteers will be offered one-to-one training and 
practice sessions to help support their competence and confidence in delivering the seated exercises 
safely and effectively. Based upon the ImPACt study it is predicted that volunteers might need 1-3 
one-to-one exercise training and practice sessions with the trainer. The trainer, Dr Samantha 
Meredith, is a research fellow and clinical exercise instructor with extensive experience delivering 
exercise to a range of population groups, including older adults, and within various rehabilitation 
settings.  
 
Nutrition support: Volunteers will be trained to use the Nutrition Wheel by Dr Samantha Meredith, 
supported by Prof Jane Murphy, during a 2-hour session with accompanying support materials. The 
training will cover principles of healthy eating, information on undernutrition (e.g., prevalence, risk 

 
 
 
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factors, identification and treatment), details on the Nutrition Wheel, and an opportunity to use the 
Nutrition Wheel in a role play context.   
 
Behaviour change support: The training, which is based on Healthy Conversation Skills (HCS), will 
be delivered by a health psychologist (Judit Varkonyi-Sepp). HCS training develops four key 
competencies: 1) asking open discovery questions (‘how’ and ‘what’ questions), 2) listening instead of 
making suggestions or giving advice, 3) reflecting on practice, and 4) setting goals using SMARTER 
(specific, measurable, action-oriented, realistic, timed, evaluated, reviewed) planning [56]. The training 
will be 3 hours of in-person interactive learning to support volunteers to deliver exercise and nutrition 
components in an encouraging, person-centred way, translating MECC principles into practice.  
 
Digital training 
To address equality of access, participants can be provided with a tablet with the online 
teleconferencing platform preloaded. The tablet will contain a SIM card which will enable internet 
access at home, particularly for participants who do not have internet access. The research fellow will 
act as a digital champion who will support individuals with low confidence to access the 
teleconferencing platform. Upon recruitment, participants will be taught how to use the tablet and to 
access the teleconferencing platform during their hospital stay. They will be given a digital support 
booklet and will be given guidance about how to stay safe online. Digital support will be available to 
participants throughout the trial. 
 
Volunteer Support and Fidelity Checks 
Throughout the study a peer-supported community will be established through regular online monthly 
volunteer meetings to discuss experiences and gain feedback from peers and trainers. The research 
team will work closely to support volunteers, including listening and providing any emotional support 
on a group and individual basis. Volunteer feedback will be integral to shaping the support that 
volunteers will need in delivering the intervention and ensuring volunteer well-being. In addition, 
trainers will conduct regular fidelity checks (once per month) to assess the quality of group sessions 
delivered by volunteers. The volunteers will be observed and assessed against a competency and 
implementation checklist, including competency checks for the exercise, nutrition, and behaviour 
change components. Based upon fidelity checks and volunteer feedback, extra one-to-one training 
sessions, emotional and confidence support, will be available if necessary. 
 
Volunteers will be given a training manual to help support their learning and to be used as a resource 
during delivery of the intervention. Volunteers will also be asked to keep an attendance record during 
the intervention using session completion logs and will be trained to report any adverse events.   
 
Safety during sessions 
Volunteers will be encouraged to complete a pre-session screening checklist to ensure participants 
are safe to exercise (e.g., safe set-up of a home exercise space; feeling well; no new or worsening 
symptoms). Volunteers will be taught to encourage participants to exercise at their own pace, to rest 
when they need to, and to move within a pain-free range of motion, ensuring that participants are 
working at a tailored intensity. Where possible participants will be encouraged to undertake the 
sessions with friends or family members present and they will be asked to keep cameras on during the 

 
 
 
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sessions. If a participant feels unwell a Zoom breakout room will enable the participant’s well-being to 
be reviewed in private by a second volunteer.  
 
If an emergency occurs, such as an acute medical event during the session, the volunteer will 
encourage participants to call their GP, or 111. If concerned about collapse, the volunteer will call 999. 
Volunteers will have a list of participant's addresses and GPs to hand - in case of collapse. An 
‘escalation plan’ giving clear steps to follow, depending on the emergency situation, will be given to 
volunteers. 
 
Data Collection 
Participant characteristics including age, gender, domicile status, weight, body mass index, 
malnutrition status (MUST), baseline nutritional status (e.g., use of nutritional supplements and 
dietician support), co-morbidities (Charlson Co-morbidity Index) [57], cognition (Mini-mental state 
examination; MMSE) [58] and number of medications will be recorded. Volunteer characteristics 
recorded will include age, occupation, qualifications, volunteering experience, and employment status. 
 
The primary outcome measures are feasibility and acceptability of the intervention. 
 
Feasibility 
The feasibility of implementing a volunteer-led online multi-modal intervention will be assessed by 
determining the number of volunteers recruited, trained and retained at the end of the study, the 
number of intervention sessions delivered and fidelity of volunteer delivery. Moreover, participant 
recruitment, retention and adherence to the intervention will be measured, as well as any adverse 
events. 
 
Acceptability of the intervention 
Interviews will be conducted among older adults (N= 6), volunteers (N= 6), and those involved in 
recruiting participants and training volunteers (N= 3), to determine the acceptability of the intervention 
and to explore barriers and enablers to the implementation of the intervention. Interviews will be semi-
structured to help guide conversation whilst allowing participants the flexibility to elaborate and reflect 
on any meaningful experiences.  
 
Older adults will be selected by purposive sampling to share their thoughts and views regarding the 
implementation of the volunteer-led sessions. To ensure a wide range of views are included in the 
interviews, participants will be selected to ensure equal distribution of male and female patients, 
ethnicities, and a representative age range. Interviews will also be conducted for volunteers leading 
the intervention. Discussions among volunteers are likely to generate a wider perspective of the 
implementation process and may provide insight into the group narrative on their experiences in 
delivering the intervention and their interaction with the research participants. Interviews will be 
conducted via telephone and will be audio-recorded for data collection purposes.  
 
The interviews will be semi-structured and consist of several key open-ended questions that will help 
define the areas explored but allow the interviewer or interviewee to expand and diverge with the aim 

 
 
 
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of pursuing or developing an idea with more depth. The interview schedules will be underpinned by 
Normalisation Process Theory (NPT) (see below). The interviews will seek to explore the views of 
older adults, volunteers and trainers on the multi-component sessions, the barriers and facilitators to 
the intervention and suggestions for future implementation studies. 
 
The NPT provides a set of sociological tools to understand and explain the social processes through 
which new or modified practice of thinking, enacting, and organizing work are operationalized in 
healthcare and other institutional settings. The use of an implementation theory is useful as it helps 
researchers identify, describe and explain important elements of the implementation process. The 
three core problems which the theory is concerned with are: implementation (bringing of a practice or 
practices into action), embedding (routine incorporation of practice or practices into everyday work of 
individuals and groups) and integration (reproduction and sustainability of a practice or practices 
among the social matrices of an organization or institution). NPT was used in the development of the 
study protocol as well as the online physical activity and nutrition intervention. The online NPT toolkit 
was used to assist in critically thinking through the processes and challenges which may arise in 
implementing and integrating an intervention in a complex health care setting.  NPT was chosen as 
the framework that underpinned this study as it was systematic in its approach, easy to understand 
and provided a proven framework to evaluate the implementation process of this study. Determining 
the acceptability of the intervention through qualitative measures will aid future implementation 
studies. 
 
Secondary outcome measures: The secondary outcomes will include the measurement of physical 
activity levels, physical function, appetite, well-being, anxiety and depression, and self-efficacy for 
managing chronic disease. These measures are detailed below and will be measured at baseline (in 
hospital), 3 months (via telephone) and 6 months (via telephone).  
 
Physical activity: PA will be measured using the physical activity scale for the elderly (PASE) [59]. 
The PASE measures a broad spectrum of activities including leisure-time, household, and 
occupational PA during the previous 7 days, and has good stability and convergent validity within 
community-dwelling older adults [60].  
 
In addition to the PASE, PA and sleep will be assessed objectively using wrist-worn accelerometers 
(GENEActiv, Activinsights, Kimbolton, Cambridge, UK). These devices have previously been 
validated for use in healthy adult populations [61] and are extensively used in clinical studies. The 
GENEActiv accelerometers will measure triaxial movement acceleration in gravity (g) units (1 g = 
9.81 m/s2) at a frequency of 100Hz continuously over a period of 7 days. Previously validated 
acceleration threshold values (in older adults) will be used to quantify the time (minutes/day) spent 
on average in each intensity category: total PA, and separately for light, moderate, vigorous 
intensities and the composite category moderate-vigorous PA (MVPA) [62]. GENEActiv watches will 
be posted to participants to collect 7 days of objective PA levels upon discharge from hospital 
(baseline) and at 3 and 6 months. GENEActiv watches will be returned through pre-paid return 
postage.    
 
Physical function: Barthel Index will be used to measure older adult’s functional ability [63]. The 
Barthel Index consists of ten items and is predominantly used with patient populations and infrequently 
used for community-dwelling people with reasonable reliability and good responsiveness [64]. The 
Barthel Index scores 10 items describing ADL and mobility, with a higher number being a reflection of 
greater ability to function independently following hospital discharge.  

 
 
 
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Appetite: Appetite will be measured using the Simplified Nutritional Appetite Questionnaire (SNAQ) 
[65], which has been validated to predict weight loss in community dwelling older adults and used to 
predict poor health outcomes in hospitalised older people [65-67]. SNAQ is a four-item tool comprising 
items 1, 2, 4 and 6 of the CNAQ, assessing appetite, satiety, taste of food and number of meals per 
day respectively. SNAQ has a maximum score of 20, with a score of ≤14 indicating poor appetite. 
 
Well-being: Well-being will be assessed using the Warwick-Edinburgh Well-Being Scale 
(WEMWBS), which comprises 14 positively worded items relating to different aspects of positive 
mental health, including positive affect, satisfying interpersonal relationships and positive functioning 
[68]. Each item is scored on a 5-point Likert scale from 1 (none of the time) to 5 (all of the time), with 
a higher score indicating a higher level of mental well-being. The WEMWBS is a psychometrically 
robust scale showing good content validity and popularity in the measurement of well-being in 
relation to public health [68, 69].  
 
Depression and anxiety: The Hospital Anxiety and Depression Scale (HADS) will be used to assess 
anxiety and depression [70]. The questionnaire comprises seven questions for anxiety and seven 
questions for depression, and has been validated across multiple settings and populations [71]. A 
score of 0-7 is normal, 8-10 borderline abnormal, and 11-21 abnormal.  
 
Quality of life: Quality of life will be measured using the EuroQol (EQ-5D-5L) assessment comprising 
a short descriptive questionnaire and a visual analogue scale (VAS) [72]. The questionnaire includes 
5 domains (e.g., mobility; self-care; usual activities; pain/discomfort; and anxiety/depression) 
measured with 5 response levels from ‘no problems’ to ‘extreme problems/unable’. The VAS 
subjectively rates health from 0 (the worst health you can imagine) to 100 (the best health you can 
imagine). The EQ-5D-5L has been widely used in clinical trials and population studies as a popular 
measure of health status [73].  
 
Self-efficacy for managing chronic disease: A 6-item scale will be used to assess participant’s self-
efficacy in managing their chronic disease [74]. The scale contains items developed from the chronic 
disease self-management study covering domains, such as symptom control, role function, 
emotional functioning and communicating with health professionals [74]. Each item is scored on a 
10-point Likert scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate 
higher self-efficacy.  
 
Data Analysis 
Quantitative data analysis 
Data collected will be double entered into a secured database for analysis. Statistical analysis will be 
conducted using the statistical software SPSS. Descriptive statistics -median (IQR); mean (SD); 
number (%) – will be used to analyse the numbers of volunteers recruited, trained and retained, as 
well as the type and extent of progression of the resistance exercise, and duration of their activity, and 
patients’ adherence to the intervention. Analysis of the above outcome measures will be used to 
develop an assessment of the feasibility of delivering this intervention. To determine suitability for a 
future, fully-powered effectiveness study of the intervention, outcome measures recorded at baseline 
will be compared to measurement at 3 and 6 months to determine if the intervention had an impact on 
physical activity levels measured by PASE and GENEActiv, functional outcomes including Katz, 
Barthel, SNAQ, HADS, WENWBS, self-efficacy and EQ-5D-5L. The distribution of each outcome 
measure will be assessed for normality and described using parametric or non-parametric statistics 

 
 
 
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accordingly. A basic cost-analysis of the training programme will be carried out, costing the time of 
clinical staff involved in delivering the training.  
 
Qualitative data analysis 
Data collected from the interviews will be transcribed verbatim and analysed using thematic analysis 
(TA). The audio-recordings will be transcribed by an administrative colleague within the research 
department who is experienced in transcribing qualitative data. TA is a method for identifying, 
analysing and reporting patterns or themes within data and is widely used in qualitative research [75]. 
There are six phases in the process of conducting TA: Phase 1 – familiarising with the data, Phase 2 – 
generating initial codes, Phase 3 – searching for themes, Phase 4 – reviewing themes, Phase 5 – 
defining and naming themes, and Phase 6 – producing the report. Analysis of qualitative data will be 
conducted using either Microsoft Word, or with the help of NVIVO, depending on the amount of data 
collected. Transcribed text will be read and coded separately and then together by two researchers. 
The codes will be analysed to generate concepts and ideas to determine the acceptability of the 
intervention, and to identify facilitators and barriers to the implementation process.  The codes act as 
tags or labels to help catalogue key concepts embedded within the raw data. From the codes, themes 
will be developed to reflect the views and experiences of the community-dwelling older adults and 
volunteers regarding the community-based PA intervention.  
 
6 
STUDY SETTING 
This is a single-centre feasibility study taking place at University Hospital Southampton NHS 
Foundation Trust. Patients on the discharge pathway will be identified and recruited from acute 
medical wards at UHS and volunteers will be recruited from UHS voluntary services. Volunteers will 
complete study training at UHS and will deliver the online intervention from UHS. Recruited older 
adults with frailty will participate in an online intervention from their own home upon discharge from 
hospital. Interviews will take place on the phone, or an online platform while participants are at home.    
 
7 
SAMPLE AND RECRUITMENT 
7.1  
Eligibility Criteria 
Older adults with frailty discharged from UHS and volunteers from the UHS patient support hub will be 
invited to participate in this study (see details below).  
7.1.1 Inclusion criteria  
Patients:  
• 
Older adults aged 65 years and above  
• 
Able to provide written consent 
• 
Discharged from UHS 
• 
Identified as frail (Clinical Frailty Scale ≥5) 
• 
Able to walk at least a few steps upon hospital discharge 
• 
Able to communicate fluently enough in English 
 
Volunteers: 
• 
Established volunteers at UHS patient support hub 

 
 
 
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• 
Age 16 years and above 
• 
Completed the generic volunteer clearance and training at UHS 
• 
Able to provide written informed consent 
• 
Able to communicate fluently enough in English 
 
7.1.2 Exclusion criteria  
Patients:  
• 
Older adults who are not able to safely complete the exercises included in the intervention as 
advised by the patient’s clinician 
• 
Patients who are discharged to rehabilitation units, or care homes 
• 
Patients receiving end of life care 
 
Volunteers:  
• 
Volunteers who are unable to safely complete the exercises included in the intervention will be 
excluded from the study 
 
7.2  
Sampling 
 
Participants will be recruited from UHS using purposive sampling techniques (detailed below).  
 
7.2.1  Size of sample 
Patients: A sample size of 23 participants was chosen in line with previous sample size 
recommendations for feasibility studies of 12-50 participants (Julious, 2005) [76, 77].  This sample size 
was considered an appropriate number that is pragmatic and achievable within the study timescale 
and resources available.  
 
Volunteers: A sample size of 6 volunteers was chosen to provide sufficient cover to deliver the 
Frail2Fit intervention to groups of 5-6 older adults with 2 volunteers supporting each group.  
 
7.2.2  Sampling technique 
Purposive sampling will be applied to recruit patients on UHS acute medical wards to participate in the 
study, who meet the characteristics and eligibility criteria. Purposive sampling of volunteers from the UHS 
patient support hub will be applied to select appropriate volunteers who meet eligibility criteria for the 
study.  
 
7.3 
 Recruitment 
Eligible patients will be identified and approached initially by their clinical care team, and volunteers 
will be identified and approached by the UHS voluntary services manager before being approached by 
the research team (details below).  
 

 
 
 
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7.3.1 Sample identification 
Patients: Older adults on acute medical wards at UHS will be informed about the opportunity to 
participate in the study by ward staff. The clinical care team will identify eligible patients for 
participation in the research in line with inclusion criteria through existing access to their medical 
records. Ward staff will liaise closely with the research team to inform them of interested participants. 
Patients interested in the study will then be approached by the research team who will complete 
informed consent and additional screening checks to determine their suitability to participate in the 
study, including the clinical frailty scale (CFS). 
 
The CFS is a judgment-based frailty tool that evaluates specific domains including comorbidity, 
function and cognition to generate a frailty score on a 9-point scale ranging from 1 (very fit/robust and 
active) to 9 (terminally ill) [78]. The CFS is a valid and reliable measure of frailty in older people and is 
associated with a range of clinical outcomes including comorbidity, falls, cognition, function, and 
mortality [79]. Patients scoring ≥5 on CFS will be eligible to participate in the study. 
 
Volunteers: Volunteers will be identified by hospital voluntary services within the UHS patient support 
hub, managed by Emma Squires. The patient support hub helps ensure patients with a range of needs 
are supported in their own homes following discharge from hospital, including providing food parcels, 
and befriending services. The patient support hub recruits volunteers with an interest in supporting 
patients post-discharge with practical and emotional support. The research team will liaise closely with 
the patient support hub in the recruitment and support of volunteers interested in participating in the 
Frail2Fit study. The support hub team will identify and approach existing patient support hub 
volunteers to invite them to the study. All volunteers associated with the support hub will have 
appropriate clearance and training from UHS. Interested volunteers will be approached by the 
research team with a participant information sheet and if they meet eligibility criteria (i.e., no 
contraindications to the exercise component) they will complete informed consent. Two volunteers will 
be matched based upon volunteer experience levels to deliver the Frail2Fit intervention to a group of 
5-6 participants (i.e., any newer volunteers will be matched with experienced support hub volunteers).  
 
7.3.2 Consent 
The clinical care team, or volunteer services manager will inform the research team of any interested 
patients and volunteers, respectively. Interested participants will then be approached by the research 
team to explain the study in more depth and given a participant information sheet. If the participants are 
still keen to volunteer following response to any of their questions and explanation of the participant 
information sheet, then they will complete a written consent form. 
 
Participants will be given 2 days to decide if they would like to volunteer in the study. This will give 
participants time to consider their involvement in the study, to discuss the study with family and to ask any 
questions, while also enabling recruitment for the study before patients are discharged. All members of 
the study team are adequately trained in Good Clinical Practice (GCP) and have experience taking 
informed consent in previous research.  
 
8 
ETHICAL AND REGULATORY CONSIDERATIONS 
 

 
 
 
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8.1 
Assessment and management of risk 
 
There are minimal risks involved in this study. This study does not involve any invasive procedure. It is 
perceived that the benefits of the intervention outweigh potential risks. Studies have shown that 
exercise training and nutrition support are beneficial in improving physical function of older people. 
One of the benefits of taking part in the study is that volunteers and patients will be taught evidence-
based exercises and nutrition advice which will be conducted in group online sessions. Moreover, 
exercising in an online group can also be a positive experience as the social aspect of group exercises 
has been shown to be a source of motivation.  
 
Although the risks involved in the study are minimal, common injuries that may occur during exercises 
include muscle strain and back pain. Nevertheless, these risks will be reduced through various 
approaches explained below. Hospital volunteers are covered by NHS indemnity insurance in the case 
of any adverse events. 
 
• 
Volunteers will complete evidence-based training modules to ensure they are competent to 
deliver the intervention to frail older adults. All volunteers recruited by voluntary services at the 
hospital have completed generic safety checks (e.g., criminal record checks) and basic training 
(e.g., health and safety). 
• 
Volunteers will be taught to encourage participants to exercise at their own pace, to rest when 
they need to, and to move within a pain-free range of motion, ensuring that participants are 
working at a tailored intensity. 
• 
Throughout the study period, fidelity checks will be conducted by the trainers once every 2 
weeks to ensure that the volunteers are delivering high quality group sessions. The volunteers 
will be observed and assessed against a competency and implementation checklist, including 
competency checks for the exercise, nutrition, and behaviour change components. 
• 
Volunteers will complete a pre-session screening checklist to ensure participants are safe to 
exercise (e.g., safe set-up of a home exercise space; feeling well; no new or worsening 
symptoms).  
• 
Where possible participants will be encouraged to undertake the sessions with friends or family 
members present and they will be asked to keep cameras on during the sessions.  
• 
If a participant feels unwell a Zoom breakout room will enable the participant’s well-being to be 
reviewed in private by a second volunteer.  
• 
If an emergency occurs, such as an acute medical event during the session, the volunteer will 
encourage participants to call their GP, or 111. If concerned about collapse, the volunteer will 
call 999.  
• 
Volunteers will have a list of participant's addresses and GPs to hand - in case of collapse. An 
‘escalation plan’ giving clear steps to follow, depending on the emergency situation, will be 
given to volunteers. 
• 
Volunteers will be trained to support participants using the nutrition wheel and will not be 
expected to give participants specialised nutrition advice. Volunteers will be trained to 
effectively and safely signpost participants to suitable resources and health professional 
support based upon answers given from the nutrition wheel.   
 
 
A potential burden for some patients could be issues with learning new technology or having minor 
difficulties in accessing Zoom from home. To address equality of access, participants will be provided 
with a tablet with the online teleconferencing platform preloaded. The tablet will contain a SIM card 
which will enable internet access at home, particularly for participants who do not have internet 

 
 
 
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access. The research fellow will act as a digital champion who will support individuals with low 
confidence to access the teleconferencing platform. Upon recruitment, participants will be taught how 
to use the tablet and to access the teleconferencing platform during their hospital stay. Digital support 
will be available to participants throughout the trial. 
 
Participants will be given the option to choose between the online intervention and telephone 
consultations. Participants who opt for telephone consultations will be encouraged by volunteers to 
perform the exercises provided in the booklet and will be given nutritional advice. The frequency of 
telephone consultations will be similar to the online intervention. 
 
Previous research (the ImPACt study) has gained feedback from interviews with volunteers and found 
some volunteers experienced an increased sense of purpose and belonging and improved confidence 
through leading the health intervention with older adults. Nevertheless, some volunteers described a 
small burden level, especially if they were volunteering on their own. In response to this feedback, we 
will ensure that 2 volunteers will be allocated per group of 5-6 participants, so the volunteers can 
provide support to each other during the sessions and can ‘cover’ each other if they are unavailable. 
Two volunteers to each group worked better in previous research (the ImPACt study) and helped to 
reduce any burdens the volunteers might have felt having to support and lead the group on their own. 
In addition, the trainer will supervise the volunteers closely during the first month of the intervention to 
ensure they are adequately supported, confident and competent to deliver the intervention. The trainer 
will be freely available throughout the study to support volunteers, including provision of extra one-to-
one training sessions and regular monthly volunteer catch-up meetings to ensure that the volunteers 
are flourishing. 
 
8.2  
 Research Ethics Committee (REC) and other Regulatory review & reports 
This study will require ethical approval from the Health Research Authority (HRA). We will submit this 
study for review to the HRA NHS Research Ethics Committee through the Integrated Research 
Application System.  
• 
Substantial amendments that require review by NHS REC will not be implemented until 
that review is in place and other mechanisms are in place to implement at site.   
• 
All correspondence with the REC will be retained. 
• 
It is the Chief Investigator’s responsibility to produce the annual reports as required. 
• 
The Chief Investigator will notify the REC of the end of the study. 
• 
An annual progress report (APR) will be submitted to the REC within 30 days of the 
anniversary date on which the favourable opinion was given, and annually until the 
study is declared ended. 
• 
If the study is ended prematurely, the Chief Investigator will notify the REC, including 
the reasons for the premature termination. 
• 
Within one year after the end of the study, the Chief Investigator will submit a final 
report with the results, including any publications/abstracts, to the REC. 
Discontinuation/Withdrawal of Participants from Study: 
 

 
 
 
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Each participant has the right to withdraw from the study at any time and request that any data collected 
be deleted. It will not be possible for the participant to withdraw their data once the analysis has started 
because the data collected will already be pseudonymised and have been used.  
 
Participants can withdraw from the study without giving a reason by contacting the research team. 
 
Regulatory Review & Compliance  
Before any site can enrol participants into the study, the Chief Investigator/Principal Investigator will 
ensure that appropriate approvals from participating organisations are in place. Specific arrangements 
on how to gain approval from participating organisations are in place and comply with the relevant 
guidance.  
 
For any amendment to the study, the Chief Investigator/Principal Investigator, in agreement with the 
sponsor will submit information to the appropriate body in order for them to issue approval for the 
amendment. The Chief Investigator/Principle Investigator will work with sites (R&D departments at 
NHS sites as well as the study delivery team) so they can put the necessary arrangements in place to 
implement the amendment to confirm their support for the study as amended. 
 
Amendments  
If the sponsor wishes to make a substantial amendment to the REC application or the supporting 
documents, the sponsor must submit a valid notice of amendment to the REC for consideration. The REC 
will provide a response regarding the amendment within 35 days of receipt of the notice. It is the 
sponsor’s responsibility to decide whether an amendment is substantial or non-substantial for the 
purposes of submission to the REC. 
 
Amendments also need to be notified to the national coordinating function of the UK country where the 
lead NHS R&D office is based and communicated to the participating organisations (R&D office and local 
research team) departments of participating sites to assess whether the amendment affects the NHS 
permission for that site. Note that some amendments that may be considered to be non-substantial for 
the purposes of REC still need to be notified to NHS R&D (e.g. a change to the funding arrangements).  
 
The amendment history will be tracked through allocating version numbers and dates to the protocol and 
any study resources, which will be kept on electronic file by the CI and study sponsors.  
 
8.3  
Peer review 
The protocol has undergone proportionate review to assess the scientific robustness and clinical 
safety of the study by 2 independent experts in the field of Academic Geriatric Medicine and the funder 
from the University Hospital Southampton NHS Foundation Trust. No reviewers have been involved in 
the development of the protocol.  
 
8.4  
Patient & Public Involvement 
 
We have previously gathered the views from 92 older people from lunch clubs (42), care homes (11) 
and a hospital (39) regarding the use of volunteers in supporting personal care of hospitalised older 
adults. 45% of the respondents had experience with hospital volunteers and all spoke highly of their 
contribution. Most participants thought volunteers could be trained to help with mobility.  

 
 
 
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In the Southampton Mobility Volunteer study (SoMoVe), patients spoke highly of the volunteers and 
appreciated the motivation and encouragement received to walk or perform exercises [44]. The social 
interaction with the volunteers was also a positive experience. A recent survey was conducted to 
gather the views of older adults attending community clubs regarding the use of trained volunteers to 
deliver group exercises. 47 of the 50 club attendees agreed or strongly agreed to have volunteers lead 
the group exercises.  
 
Our previous work has shown that older people are keen to work with volunteers and have reported 
positive experiences in their interaction with them. Wessex Fit 4 Cancer group includes an established 
patient representation group including sitting members of the board and trial steering groups. They 
were key contributors to the online trial design and training package. 
 
Two public and patient representatives (PPIR) provided input into this study proposal. They reviewed 
the plain English summary and study proposal and proposed minor changes. Their input will also be 
sought in the development of the study protocol. They will review all patient-facing materials to ensure 
that adequate information is provided to patients and that any written information is understandable 
and jargon-free. PPIR will also be invited to join the study management group. This group will aim to 
meet up quarterly to discuss the study progress and PPIR will be involved throughout the study 
process from development to dissemination of study findings. 
 
8.5 Protocol compliance  
 
Protocol compliance will be managed by the CI, study management team and study sponsor. Accidental 
protocol deviations can happen at any time. Protocol deviations will be adequately documented on the 
relevant forms and reported to the Chief Investigator and Sponsor immediately. Deviations from the 
protocol which are found to frequently recur are not acceptable, will require immediate action and could 
potentially be classified as a serious breach. 
 
8.6 
Data protection and patient confidentiality  
The study staff will ensure that the participants’ anonymity is maintained. Data will be identified only by 
a participant ID number. All documents will be stored securely and only accessible by study staff and 
authorised personnel. The study will comply with GDPR and the Data Protection Act 2018, which 
requires data to be anonymised as soon as it is practical to do so. 
 
Participation and all the information collected about participants during the course of the 
research will be kept strictly confidential. Only members of the research team and responsible 
members of the University of Southampton may be given access to participant data for monitoring 
purposes and/or to carry out an audit of the study to ensure that the research is complying with 
applicable regulations. Individuals from regulatory authorities (people who check that we are carrying 
out the study correctly) may require access to participant data. All of these people have a duty to keep 
participant information strictly confidential. 
 
Data collected will be entered electronically on to a computer and stored on the university’s networked 
storage. Access to this information will be password-protected. Hard copies of participant information 
will be stored in a locked filing cabinet in a secure office in our research unit and will be accessible 
only by the research team. Audio recordings for the interviews will be deleted once they have been 
transcribed. Codes are allocated to each participant to ensure that the data is anonymised. Only the 
researchers in this study will have access to the data. In accordance with regulations 

 
 
 
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we are required to keep participant data secure for 10 years. The data may be used in future studies 
by our research team. If this happens, participant data will be used anonymously (non-identifiable 
participant information) so participants cannot be identified. Any new research studies using 
participant data will be authorised by the local research ethics committee. 
 
All participants will be made aware of the information collected during the research study during 
processes of informed consent through participant information sheets, discussions with the research 
team and completion of consent forms. 
 
8.7 
Indemnity 
University Hospital Southampton NHS FT has a specialist insurance/indemnity policy/scheme in place 
to:  
 
1. Meet the potential legal liability of the sponsor(s) for harm to participants arising from the 
management of the research 
2. Meet the potential legal liability of the sponsor(s) or employer(s) for harm to participants arising 
from the design of the research 
3. Meet the potential legal liability of investigators/collaborators arising from harm to participants in 
the conduct of the research.  
The sponsor(s) has not made arrangements for payment of compensation in the event of harm to the 
research participants where no legal liability arises. 
 
8.8 
Access to the final study dataset 
Access to data will be granted to relevant members of the research team and authorised 
representatives from the Sponsor for monitoring and/or audit purposes. The data may be used in 
future studies by our research team. If this happens, participant data will be used anonymously (non-
identifiable participant information) so participants cannot be identified. Any new research studies 
using participant data will be authorised by the local research ethics committee. 
 
9 
DISSEMINIATION POLICY 
9.1  
Dissemination policy 
The data arising from the study will be the intellectual property of the University of Southampton. On 
completion of the study, data will be analysed, and a final study report will be prepared. The study report 
can be accessed via clinicaltrials.gov and the ARC Wessex website (NIHR Applied Research 
Collaboration for Wessex). Research findings will be made available to research participants upon 
request.  
 
The study findings will be presented at national and international scientific meetings. They will also be 
published in peer-reviewed journals to disseminate findings to the scientific community. Social media 
platforms such as Twitter, Facebook and blogs will also be used to disseminate research findings, which 
will achieve a wider reach of scientific and lay communities. Members of PPI in the steering group will 
also provide input on other dissemination methods and ideas. This feasibility and acceptability study will 
provide a blueprint for future implementation studies on a larger scale. On completion of this study we will 
work with Wessex AHSN and the National Association of Voluntary Services Manager to develop an 

 
 
 
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implementation plan with the aim to roll out the intervention across the Hampshire and Isle of Wight 
region and nationally at a later stage. 
 
9.2  
Authorship eligibility guidelines and any intended use of professional writers 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study. Authorship will be determined per the ICMJE guidelines 
and other contributors will be acknowledged. 
 
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Wilson, M.M., et al., Appetite assessment: simple appetite questionnaire predicts weight loss in 
community-dwelling adults and nursing home residents. Am J Clin Nutr, 2005. 82(5): p. 1074-81. 
68. 
Tennant, R., et al., The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK 
validation. Health Qual Life Outcomes, 2007. 5: p. 63. 
69. 
Shah, N., et al., Responsiveness of the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS): 
evaluation a clinical sample. Health Qual Life Outcomes, 2018. 16(1): p. 239. 
70. 
Zigmond, A.S. and R.P. Snaith, The hospital anxiety and depression scale. Acta Psychiatr Scand, 1983. 
67(6): p. 361-70. 
71. 
Stern, A.F., The hospital anxiety and depression scale. Occup Med (Lond), 2014. 64(5): p. 393-4. 
72. 
Janssen, M.F., et al., Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight 
patient groups: a multi-country study. Qual Life Res, 2013. 22(7): p. 1717-27. 
73. 
Devlin, N.J. and R. Brooks, EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ 
Health Policy, 2017. 15(2): p. 127-137. 
74. 
Lorig, K.R., et al., Effect of a self-management program on patients with chronic disease. Eff Clin Pract, 
2001. 4(6): p. 256-62. 
75. 
Braun, V. and V. Clarke, What can "thematic analysis" offer health and wellbeing researchers? Int J Qual 
Stud Health Well-being, 2014. 9: p. 26152. 
76. 
Lancaster, G.A., S. Dodd, and P.R. Williamson, Design and analysis of pilot studies: recommendations 
for good practice. J Eval Clin Pract, 2004. 10(2): p. 307-12. 
77. 
Sim, J. and M. Lewis, The size of a pilot study for a clinical trial should be calculated in relation to 
considerations of precision and efficiency. J Clin Epidemiol, 2012. 65(3): p. 301-8. 
78. 
Rockwood, K., et al., A global clinical measure of fitness and frailty in elderly people. CMAJ, 2005. 
173(5): p. 489-95. 
79. 
Church, S., et al., A scoping review of the Clinical Frailty Scale. BMC Geriatr, 2020. 20(1): p. 393. 
New reference added: Julious, S. A, Sample size of 12 per group rule of thumb for a pilot study. 
Pharmaceutical Statistics, 2005. 4: p. 287-291.  
 
 

 
 
 
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11.  
APPENDICIES 
 
11.1 
Appendix 1- Required documentation  
CV of Chief Investigator 
Participant Information Sheet 
Participant Consent Form 
Consultant Letter 
Referee’s Report 
Letter from Funder 
Data Collection Booklet 
Interview Schedule 
Screening and Escalation Plan 
 
11.2  Appendix 2 – Schedule of Procedures  
 
Procedures 
No. received 
per 
participant 
Time 
Who  
Location 
Written consent (volunteers & 
patients) 
1 
5-10 
mins 
SL & SM 
Hospital Wards 
Questionnaire pack data 
collection (patients) 
3 
30-45 
mins 
SM 
Baseline: on hospital 
wards. 3 and 6 month 
Collections: on the 
telephone with 
participants at home. 
Questionnaire measuring 
characteristics (volunteer) 
1 
15-20 
mins 
SM 
Telephone while 
participant at home 
Volunteer training 
4 
1-2 
hours 
SM / SL/ 
Dietician / 
Psychologist 
Depending on covid 
guidelines the training will 
either be online (e.g., 
Zoom, or Teams), or will 
be in-person at UHS. 
Volunteer fidelity check 
4-6 
1 hour 
SM 
Observing volunteers 
online while they deliver 
intervention. 
Group volunteer meeting 
3 
30-45 
mins 
SM / SL 
Online (Zoom, or 
Microsoft Teams) 
Interview (volunteers and 
patients) 
1 
25-45 
mins 
SM 
Telephone, or online. 
Physical activity 
measurement - wearing 
GENEActiv watch (patients) 
3 
7 days 
SM 
Baseline assessment: on 
the ward at UHS.  
3 and 6 

 
 
 
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month assessments: 
participant's home, in 
which watches will be 
posted out. 
Group exercise and nutrition 
intervention 
24 
1 hour 
Trained 
Volunteers 
Online (Zoom) 
 
 
13.3 
Appendix 3 – Amendment History 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Stephen Eu Ruen Lim 
Profile 
GMC number:  
7082136 
Job description: 
Consultant Geriatrician, Clinical Academic in Geriatric Medicine 
Current post:  
University Hospital Southampton NHS FT 
Qualifications 
Bachelor of Medicine, Bachelor of Surgery,  
University of Southampton   
 
 
 
 
 
July 2010 
MRCP Part 1  
 
 
 
 
 
 
 
October 2011 
MRCP Part 2  
 
 
 
 
 
 
 
May 2012 
MRCP Paces 
 
 
 
 
 
 
 
July 2013 
Speciality Certificate Examination in Geriatric Medicine 
 
April 2016 
PhD in Human Development and Health,  
University of Southampton  
 
 
 
 
 
December 2018 
 
Appointments held 
Consultant Geriatrician, University Hospital Southampton NHS FT 
NIHR Academic Clinical Lecturer and Honorary Specialist Trainee in Geriatric Medicine, 
Southampton General Hospital, Salisbury District Hospital, Lymington New Forest Hospital, 
2018-21 
ST6 in Geriatric Medicine, Queen Alexandra Hospital, 2017-18 
NIHR CLAHRC Clinical Research Fellow and Honorary Specialist Trainee in Geriatric 
Medicine, Southampton General Hospital, 2015-17 
NIHR Academic Clinical Fellow and ST3 in Geriatric Medicine, Southampton General 
Hospital 2014-15 
Core Medical Trainee 1 & 2, Queen Alexandra Hospital, 2012-13 
Foundation year trainee 1 & 2, Southampton General Hospital, Lymington New Forest 
Hospital, 2010-12 

 
 
 
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1. NIHR Academic Clinical Fellowship (2014–15) 
2. NIHR CLAHRC Wessex. SoMoVe study: £90,369.00 (2015-17) (Principal investigator) 
3. NIHR Academic Clinical Lecturer in Geriatric Medicine (2018–21) 
4. British Geriatrics Society Specialist Registrar Grant 2018 : £1000 
5. NIHR ARC Wessex. ImPACt study: £82,363.80 (2020-22) (Principal investigator) 
6. NIHR ARC Wessex. Implementing Digital Activity study: £38,000.00 (2021–22) (Co-
Investigator) 
7. The Burdett Trust for Nursing Pneumo 65 study: £100,000 (2019-2022) (Co-
investigator) 
8. University Hospital Southampton NHS Trust. Wessex Frail2fit study: £51,019 (2021-23 
(Lead investigator) 
9. University Hospital Southampton Research Leaders’ Programme: £51,735.40 (2022-
2025) (Lead applicant) 
 
 
 
 
1. NIHR Annual Trainees Meeting 2016 – Poster competition prize winner 
2. University of Southampton Health and Medical research conference 2017 – Highly 
Commended award for poster presentation 
3. University of Southampton Faculty of Medicine 3 minute thesis competition 2018 – 
Winner 
4. University of Southampton 3 minute thesis grand final 2018 – People’s Choice 
Winner  
5. Southampton Medical and Health Research Conference 2018 – 3 Minute Oral 
Presentation Prize Winner 
Fellowships/ Grants 
Awards/ Prizes 

 
 
 
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6. 9th NIHR Infrastructure Doctoral Research Training Camp 2018 – Highly Commended 
Poster Award 
7. British Geriatrics Society Autumn Meeting 2018 Presidential Abstract Round 
8. Royal College of Physician Turner-Warwick Lecturer 2019  
9. British Geriatrics Society Autumn Meeting 2019 Presidential Abstract Round 
10. University of Southampton – Michael Arthur Research Prize 2020 (for the best 
research publication by a clinical academic trainee) 
 
 
 
 
1. Lim S, Patel H. Paraneoplastic syndrome in older people. CME Journal Geriatric 
Medicine 2012;14(2):82-92  
2. Baczynska AM, Lim SE, Sayer AA, Roberts HC. The use of volunteers to help older 
medical patients mobilise in hospital: a systematic review. Journal of Clinical Nursing 
2016; 25(21-22):3102-3112 
3. Lim SER, Ibrahim K, Sayer AA, Roberts HC. Assessment of physical activity of 
hospitalised older people: a systematic review. The Journal of Nutrition, Health and 
Ageing, 2018; 22(3):377-286 
4. Lim SER, Bacon D, Dodds R, Sayer AA, Roberts HC. Physical activity among 
hospitalised older people: insights from upper and lower limb accelerometry. Aging 
Clinical and Experimental Research. 2018;30(11):1363-1369 
5. Roberts HC, Lim SE, Cox N, Ibrahim K. The challenge of managing undernutrition in 
older people with frailty. Nutrients 2019 10;11(4) E808 
6. Witham MD, Roberts HC, Gladman J, Stott DJ, Sayer AA and collaborators. Growing 
research in geriatric medicine. Age and Ageing 2019;48:316-319  
7. Lim S, Ibrahim K, Dodds R, Purkis A, Baxter M, Rogers A, Sayer AA, Roberts HC. 
Physical activity in hospitalised older people: the feasibility and acceptability of a 
volunteer-led mobility intervention in the SoMoVeTM study. Age Ageing 2020 
27;49(2):283-291 
8. Geriatric Medicine Research collaboration. Growing research in geriatric medicine: 
Trainees’ perspective. Age and Ageing 2020;49(5):733-737 
9. Lim S, Cox N, Tan Q, Ibrahim K, Roberts HC. Volunteer-led physical activity 
interventions to improve health outcomes for community-dwelling older people: a 
systematic review. Aging Clinical and Experimental Research. 2020 (Online ahead of 
print) 
10. Cox NJ, Lim S, Howson F, Moyses H, Ibrahim K, Sayer AA, Roberts HC, Robinson S. 
Poor appetite is associated with six month mortality in hospitalised older men and 
women. Journal of Nutrition, Health and Aging. 2020;24(10):1107-1110 
Publications 

 
 
 
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11. Schuster S, Singler K, Lim S, Machner M, Cobler K, Dormann H. Quality Indicators for 
a geriatric emergency care (GeriQ-ED) – an evidence-based delphi consensus 
approach to improve the care of geriatric patients in the emergency department. 
Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine. 2020;28;68  
12. Coutts L, Ibrahim K, Tan QY, Lim SER, Cox NJ and Roberts HC.  Can probiotics, 
prebiotics and synbiotics improve functional outcomes for older people: a systematic 
review. European Geriatric Medicine 2020;11(6):975-993 
13. Lim S as part of Geriatric Medicine Research Collaborative. Age and frailty are 
independently associated with increased COVID-19 mortality and increased care 
needs in survivors: results of an international multi-centre study. Age and Ageing 2021. 
(online ahead of print) 
14. Gosch M, Heppner HJ, Lim S, Singler K. Recommendations for the management of 
COVID-19 pandemic in long-term care facilities. Zeitschrift für Gerontologie und 
Geriatrie 2021. (Online ahead of print) 
15. Ibrahim K, Cox N, Stevenson JM, Lim S, Fraser S, Roberts HC. A systematic review of 
the evidence for deprescribing interventions among older people living with frailty. BMC 
Geriatrics 2021; 21:258. 
16. Tan QY, Cox NJ, Lim SER, Coutts L, Fraser S, Roberts HC, Ibrahim K. The 
experiences of treatment burden in people with Parkinson’s and their caregivers: a 
systematic review of qualitative studies. Journal of Parkinsons Disease. 
2021;11(4):1597-1617  
17. J.A. Lucke, S.P. Mooijaart, P. Heeren, K. Singler, R. McNamara, T. Gilbert, C.H. 
Nickel. S. Castejom, A. Mitchell, V. Mezera, L. van der Linden, S.E. Lim, A. Thaur, 
M.A. Karamercan, L.C. Blomaard, Z.D. Dundar, K.Y. Chueng, F. Islam, B. de Groot, S. 
Conroy. Providing care for older adults in the Emergency Department: expert clinical 
recommendations from the European Task Force on Geriatric Emergency Medicine. 
European Geriatric Medicine 2021 (Online ahead of print)  
18. Lim SER, Meredith S, Agnew S, Clift E, Ibrahim K and Roberts HC. Evaluating the 
feasibility and acceptability of virtual group exercise for older adults delivered by 
trained volunteers: the ImPACt study protocol. BMJ Open 2022;12:e052631 (Online 
ahead of print) 
 
 
 
 
1. Lim SER, Purkis A, Strike G, Baxter M, Rogers A, Sayer AA, Roberts HC. Ambulatory 
activity of older inpatients on acute geriatric medicine wards. In: British Geriatric 
Society Spring Meeting; 26th – 28th April 2017; Newcastle. Age and Ageing 2017 46; 
suppl_2 p55 
2. Lim S, Strike G, Baxter M, Purkis A, Rogers A, Sayer AA, Roberts HC. The use of 
trained volunteers to encourage increased ambulatory activity among hospitalised 
Published abstracts 

 
 
 
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older people: a feasibility study. In: The 13th European Geriatric Medicine Society 
congress; 20th – 22nd September 2017; Nice. European Geriatric Medicine 2017 
8;suppl 1 p467 
3. Lim S, Ibrahim K, Dodds R, Strike G, Baxter M, Rogers A, Sayer AA, Roberts HC. The 
role of volunteers in preventing hospital-associated deconditioning among older 
people: a feasibility and acceptability study. In: The 14th European Geriatric Medicine 
Society congress; 10th – 12th October 2018; Berlin. European Geriatric Medicine 
2018;9(Suppl 1):S208 
4. Bacon D, Lim S, Roberts HC, Dodds R. What are the patterns and predictors of 
physical activity in hospitalised older adults? Findings from the Southampton Mobility 
Volunteer (SoMoVe) study. Age and Ageing 2018;47(supp 2):ii12-ii13 
5. Lim S, Ibrahim K, Dodds R, Purkis A, Strike G, Baxter M, Rogers A, Sayer AA, Roberts 
HC. Increased physical activity levels among hospitalised older people: The role of 
trained volunteers. Age and Ageing 2019;48(supp 1):i27-i30 
6. Lim SER, Cox NJ, Roberts HC. The effectiveness of volunteer-led physical activity 
interventions in improving health outcomes for community-dwelling older people: a 
systematic review. Age and Ageing 2020; 49(supp 1):i30-i32  
7. Cox NJ, Lim SER, Baylis D, Howson F, Sayer AA, Roberts HC. Poor appetite is 
common in hospitalised older people and associated with subclinical low mood. Age 
and ageing 2020;49(supp 1):i34-i36 
 
 
 
 
 
 
 
 
 
 
1. Trustee for Bethany Care Home (2019 – current) 
2. Chair of the British Geriatrics Society Trainees’ Council (2017 – 2019) 
3. Trustee and director of the British Geriatrics Society (2017 – 2019) 
4. Chair-elect of the European Geriatric Medicine Society Geriatric Emergency Medicine 
Special Interest Group (2021 – current) 
5. Committee member of the NICE Advocacy guidance committee (2021 – current) 
6. Member of the European Academy for Medicine of Aging (2021 – current) 
 
 
Official Functions 
Roles 

 
 
 
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1. Personal academic tutor (3 University of Southampton medical students) 
2. PhD supervision (1 University of Southampton PhD candidate) 
3. Supervision of a post-doctoral research fellow 
 
 
 
1. Royal College of Physicians 
2. British Geriatrics Society 
3. Medical Protection Society 
4. British Medical Association 
5. European Geriatric Medicine Society 
 
 
 
 
 
1. Reviewer for Age and Ageing, PLOS One, Frontiers in Medicine, Clinical Medicine, 
BMC Geriatrics and Journal of Aging and Physical Activity 
 
 
 
 
 
1. NIHR Ageing and BGS Wessex meeting:  Clinical Academic Training, Southampton, UK, June 
2015 
2. NIHR CLARHC Wessex Stakeholders Meeting: Southampton Mobility Volunteer study, 
Southampton ,UK, June 2016 
3. NIHR CRN Ageing and BGS Wessex conference: Southampton Mobility Volunteer study, 
Bournemouth, UK December 2016 
4. Helpforce Conference: Southampton Mobility Volunteer study, London, UK, June 2017 
5. British Geriatrics Society Autumn Meeting: Deconditioning among hospitalised older people, 
London, UK, November 2017 
Membership 
Scientific Functions 
Invited lectures 

 
 
 
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6. NIHR CLAHRC Away Day: Delivering the future for Applied Health Research: the role of 
volunteers, Southampton, UK, January 2018 
7. Healthcare Conference UK: Getting patients up, dressed and moving, London, UK, January 
2018  
8. Healthcare Confrence UK: Getting patients up, dressed and moving, London, UK, May 2018  
9. NIHR CLAHRC Celebrating Ageing research conference 2018  
10. Wessex Geriatric Medicine Training Day: Sarcopenia in older adults, Basingstoke, UK, 
Basingstoke, January 2019 
11. North West British Geriatrics Society Regional meeting: Sarcopenia, London, UK, September 
2019 
12. University of Bournemouth Falls Insight workshop, Bournemouth, UK, December 2019 
13. NIHR ARC Launch Event: Physical Activity among community-dwelling older adults: The 
ImPACt study, Basingstoke, UK, October 2019 
14. European Geriatric Medicine Society Congress – Geriatric Emergency Medicine symposium. 
Athens, Greece October 2021 
 
 
 
 
Undergraduate 
1. Supervision of 3rd year medical student BMedSci research project, University of 
Southampton 
2. Examiner of 3rd year medical student research project, University of Southampton 
3. 3rd year and final year medical students Objective Structured Clinical Examination 
(OSCE) examiner 
4. Final Year medical students Assessment of Clinical Competence (ACC) examiner, 
University of Southampton 
5. Annual lecture for international transfer students, University of Southampton 
6. Formal departmental teaching for medical students attached to the Geriatric Medicine 
department 
7. SBOM lectures and seminars for medical students, University of Southampton 
Teaching activities 

 
 
 
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8. Organised national meeting to promote Geriatric Medicine among medical students, 
Nov 2019 
Postgraduate 
1. Formal departmental teaching for junior doctors at the Geriatric Medicine department, 
University Hospital Southampton NHS FT, Queen Alexandra Hospital 
2. Teaching for senior house officers preparing for the MRCP PACES examination 
3. Organised national meeting on Frailty and Sarcopenia April 2019 
4. Teaching session at an international post-graduate course (EAMA) June 2019 
5. Teaching session at an international post-graduate course (EAMA) Jan 2020 
 
 
 
 
1. BGS and NIHR Wessex Ageing 2015 – Oral presentation 
2. NIHR Annual Trainee’s Meeting 2015 – Poster presentation  
3. NIHR CLAHRC Wessex Annual Stakeholder’s Event 2016 – Oral presentation  
4. University of Southampton Faculty of Medicine Research Conference 2016 - Poster 
presentation  
5. NIHR Trainee’s Meeting 2016 – Poster presentation 
6. BGS Spring Meeting 2017 – Poster presentation 
7. University of Southampton Faculty of Medicine Research Conference 2017 – Poster 
presentation 
8. University Hospital Southampton Quality Improvement conference 2017 – Oral presentation 
9. BGS and CRN ageing research meeting 2017 – Oral presentation 
10. European Geriatric Medicine Society congress, Nice, France 2017 – Poster presentation 
11. Southampton Medical and Health sciences research conference 2018 – Poster and oral 
presentation 
12. Rank Prize symposium on Nutrition – Oral presentation 2018 
13. 9th NIHR Infrastructure Doctoral Research Training Camp 2018 – Poster presentation 
Research Presentations 

 
 
 
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14. European Geriatric Medicine Society congress, Berlin, Germany 2018 – Poster presentation 
15. British Geriatrics Society Autumn meeting 2019 – Poster presentation  
16. University of Southampton Faculty of Medicine Research Conference 2020 - Poster 
presentation  
17. University of Southampton Faculty of Medicine Research Conference 2020 – Michael Arthur 
Research prize- Oral presentation 
 
 
 
1. Geriatrics for Undergraduate, University College London. November 2019 
 
 
 
1. NIHR CLAHRC Wessex Media training  
2. BBC South Today interview Jan 2018  
3. British Geriatrics Society Media training  
4. NIHR ARC Launch event Oct 2019  
5. Nursing Older People magazine interview 
 
 
 
1. Nomination for UHS Hospital Heroes award, 2017 
2. Research presentation with the Minister of Civil Service, 2015  
 
 
 
 
 
 
 
 
 
Media  
Conference organisation 
Impact 

 
 
 
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Participant Information Sheet (Volunteers) 
 
 
Study Title: The Frail2Fit Study: Online Nutrition and Exercise Support 
for Older Adults with Frailty 
 
Researcher: Dr Stephen Lim 
 
This project has been reviewed by the Wales REC 7 Research Ethics 
Committee. REC Reference: 22/WA/0155  
 
 
 
 
You are being invited to take part in the above research study. To help 
you decide whether you would like to take part or not, it is important 
that you understand why the research is being done and what it will 
involve. Please read the information below carefully and ask questions if 
anything is not clear or you would like more information before you 
decide to take part in this research.  You may like to discuss it with 
others but it is up to you to decide whether or not to take part. If you are 
happy to participate you will be asked to sign a consent form. 
 
What is the research about? 
 
I am a doctor specialising in the Care of Older People with an interest in 
improving the health of older people. This study aims to see if we can 
train volunteers to encourage older adults to exercise in a group and to 
provide them with nutrition support after being discharged from 
hospital. We also want to know if this is acceptable to them, and their 
family members. We will see if the exercise and nutrition support have 
an impact on the health of those taking part. This study is funded by the 
University Hospital Southampton Research and Development grants 
scheme and has been submitted to the NHS Health Research Authority 
research ethics committee for approval.  
 
Why have I been asked to participate? 
 

 
 
 
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You have been asked to take part in this study because you are a patient 
support hub volunteer at University Hospital Southampton NHS 
Foundation Trust.  
 
What will happen to me if I take part? 
 
You will be trained to deliver online group exercises and nutrition 
support for older people with frailty. Below we will outline your training 
and the online programme. 
 
Volunteer Training 
 
The training will be a combination of in-person and online content led by 
various health professionals specialising in nutrition and exercise for 
older adults. You will also be given additional resources to support your 
training including booklets and online videos. Training will take place for 
half a day in-person at University Hospital Southampton and 3 hours of 
online training. Also, we are available for any additional one-to-one 
training sessions that you would like. 
 
The training will be split into 3 main sections: 
 
1) Exercise Training: We will teach you how to safely deliver seated 
exercises to older adults online, including use of elastic resistance 
bands (2 hours). 
2) Nutrition Training: We will teach you how to engage older adults in 
conversations about their nutrition and where to signpost older 
adults for more information about healthy eating (2 hours). 
3) Behaviour Change Training: You will be invited to an online course 
in ‘healthy conversation skills’ to help you empower older adults to 
improve their exercise and nutrition (3 hours).  
 
Online Programme for Older Adults with Frailty 
 
The supportive online sessions that you will be delivering to the older 
adults will last approximately 45-60 minutes and will include 20-30 

 
 
 
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minutes of exercise and 15-25 minutes of nutrition support. You will 
also be taught how to motivate lifestyle changes and how to make sure 
the exercise and nutrition support are safe and enjoyable.  
 
We would like you to deliver the support sessions for 12 weeks to a 
small group of older adults.  
 
• In the first month (week 1-4) you will deliver 3 sessions per week. 
• In the second month (week 5-8) you will deliver 2 sessions per 
week.  
• And in the last month (week 9-12) you will deliver 1 session per 
week.  
 
You will be teamed up with another volunteer, so you can support each 
other in the delivery of the sessions. Also, the trainer will support you 
throughout the project and will organise regular group volunteer 
meetings to discuss any concerns or feedback.  
 
You may also be invited to attend an interview to share your views and 
experiences on delivering the online programme. Your details will be 
anonymised, which means that no one outside the research team will 
know your name. People will read about the things you say to us, but 
they will not know who said those things.  
 
Are there any benefits in my taking part? 
 
Studies have shown that resistance exercise training and nutrition 
support are beneficial in improving physical function. One of the 
benefits of taking part in this study is that you will be taught evidence-
based exercises and dietary advice which will be conducted in group 
sessions. By doing the exercises yourself, you are also likely to benefit 
from it. Exercising in a group can also be a positive experience as the 
social aspect of group exercises has been shown to be a source of 
motivation. By taking part in this study, you will also be contributing to 
further research to improve the health of older people.    
 
Are there any risks involved? 

 
 
 
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The risks involved in this study are minimal. Common injuries that may 
occur during exercises include muscle strain and back pain. Less 
commonly, is the risk of falls. However, the exercise programme is likely 
to help promote improvement in balance and muscle strength, which 
may help reduce the risk of falling. This study does not involve any 
invasive procedure. 
 
What will happen in case of an emergency? 
You will be taught how to deliver the support sessions safely. However, 
in the unlikely event that a participant in your group requires immediate 
medical attention (e.g., collapse) you will need to contact the emergency 
services. If a participant experiences an adverse event (e.g., a muscle 
strain) then you will need to let us know (the study team) and we will get 
in contact with them to escalate the situation further, if required. 
 
What data will be collected? 
 
We will be collecting basic information such as your gender, age and 
ethnicity. You may be interviewed to explore your views and experiences 
about the exercise programme. Interviews will take place on the 
telephone, or online (e.g., Zoom) depending on your personal 
preference. Interviews will be recorded using a digital audio-recorder. 
Participant information will be anonymised (non-identifiable participant 
information) during the data analysis process and published data will not 
include any identifiable participant information.  
 
 
 
 
 
 
 
 
 
 

 
 
 
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Timeline 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete baseline questionnaires 
(15 mins) 
Month 1: Deliver 3 group 
sessions per week (40-60 mins 
per session) 
Month 2: Deliver 2 group 
sessions per week 
Month 3: Deliver 1 group session 
per week  
Complete Training 
Exercise (2 hours) 
Nutrition (2 hours) 
Conversation skills (3 hours) 
Possible Interview (30-60 mins) 

 
 
 
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Will the online sessions continue when the study has finished? 
 
The online support sessions will last 12 weeks during the study. There 
will be no further online support sessions when the study has finished. 
However, participants will be given resources, including booklets and 
access to online videos to continue their exercise and nutrition changes 
at home in their own time.   
 
 
Will my participation be confidential? 
 
Your participation and the information we collect about you during the 
course of the research will be kept strictly confidential.  
 
Only members of the research team and responsible members of the 
University of Southampton may be given access to data about you for 
monitoring purposes and/or to carry out an audit of the study to ensure 
that the research is complying with applicable regulations. Individuals 
from regulatory authorities (people who check that we are carrying out 
the study correctly) may require access to your data. All of these people 
have a duty to keep your information, as a research participant, strictly 
confidential. 
 
Data collected will be entered electronically on the computer and stored 
on the university’s networked storage. Access to this information will be 
password-protected. Hard copies of participant information will be 
stored in a locked filing cabinet in a secure office in our research unit 
and will be accessible only by the research team. Audio recordings for 
the interviews will be deleted once they have been transcribed. Codes 
are allocated to each participant to ensure that the data is anonymised. 
Only the researchers in this study will have access to your data.  
 
In accordance with the regulations we are required to keep your data 
secure for 10 years.  
 
Your data may be used in future studies by our research team. If this 
happens, your data will be used anonymously (non-identifiable participant 

 
 
 
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information) so you cannot be identified. Any new research studies using 
your data will be authorised by the local research ethics committee.   
 
Do I have to take part? 
 
No, it is entirely up to you to decide whether or not to take part. If you 
decide you want to take part, you will need to sign a consent form to 
show you have agreed to take part.  
 
Please inform the researcher if you wish to take part and the research 
team will be in touch with you to provide you with more information and 
go through the consent process.  
  
What happens if I change my mind? 
 
You have the right to change your mind and withdraw at any time 
without giving a reason and without your participant rights being 
affected. Please inform the researcher if you wish to withdraw from the 
study.   
 
If you do not wish to carry on with this study, you can withdraw at any 
time without giving a reason. If you decide to withdraw we would like to 
retain the use of anonymised (non-identifiable participant information) 
routine data and any data already collected which would be important for 
the overall study results.  
 
What happens if I have given consent but then lose capacity to consent 
during the study? 
 
You and all your identifiable data collected during the study would be 
withdrawn from the study. Data which is not identifiable to the research 
team may be retained. 
 
What will happen to the results of the research? 
 

 
 
 
FRAIL2FIT 
 
   
 
xlii 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
Your personal details will remain strictly confidential. Research findings 
made available in any reports or publications will not include information 
that can directly identify you without your specific consent. The results of 
the research will be published in scientific journals.  Research staff may 
also present the results at conferences and local meetings, and on a 
website where it would be available to members of the public.  You will 
not be identified in any report produced.  
 
If you are interested, when we have finished analysing the study data, the 
research team will phone you to share the results. We will also place the 
study findings on a website (https://www.arc-wx.nihr.ac.uk/) 
and point you to any open access research publications. If you are 
interested but do not have access to the internet we can post the results 
upon request.  
 
 
Where can I get more information? 
 
For further information, please contact me (Dr Stephen Lim) at  
s.e.lim@soton.ac.uk, or by telephone 023 8120 6131. 
 
Or you can contact the research assistant Dr Samantha Meredith at 
s.j.meredith@soton.ac.uk, or by telephone 078 2510 4783. 
 
What happens if there is a problem? 
 
If you have a concern about any aspect of this study, you should speak 
to the researchers who will do their best to answer your questions.  
If you remain unhappy or have a complaint about any aspect of this 
study, please contact the University of Southampton Research Integrity 
and Governance Manager (023 8059 5058, rgoinfo@soton.ac.uk). 
 
NHS Indemnity Insurance 
 

 
 
 
FRAIL2FIT 
 
   
 
xliii 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
The University Hospital Southampton NHS Foundation Trust will act as 
sponsor for this research study and will provide insurance for the study 
through the NHS indemnity scheme. The insurance will meet the 
potential legal liability of the sponsor for harm to participants arising 
from the design of the research and the potential legal liability of 
investigators/collaborators arising from harm to participants in the 
conduct of the research. Moreover, volunteers will be insured by The 
Liabilities to Third Parties Scheme (LTPS) through NHS Resolutions. This 
will provide volunteers with employer’s liability, public liability, products 
liability, and professional indemnity cover. 
 
 
How will we use information about you?  
 
We will need to use information from you for this research project.  
This information will include your: 
• Name 
• Age 
• Address 
• Telephone number 
• Gender 
• Medical status 
 
People will use this information to do the research or to check your 
records to make sure that the research is being done properly. People 
who do not need to know who you are will not be able to see your name 
or contact details. Your data will have a code number instead.  
 
We will keep all information about you safe and secure.  
Once we have finished the study, we will keep some of the data so we 
can check the results. We will keep identifiable information about you for 
10 years after the study has finished after which time any link between 
you and your information will be removed and stored data will be 
destroyed. We will write our reports in a way that no-one can work out 
that you took part in the study. 
 

 
 
 
FRAIL2FIT 
 
   
 
xliv 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
What are your choices about how your information is used? 
• You can stop being part of the study at any time, without giving 
a reason, but we will keep information about you that we 
already have.  
• We need to manage your records in specific ways for the 
research to be reliable. This means that we won’t be able to let 
you see or change the data we hold about you.  
 
Where can you find out more about how your information is used? 
You can find out more about how we use your information  
• at www.hra.nhs.uk/information-about-patients/ 
• our leaflet available from www.hra.nhs.uk/patientdataandresearch 
• by asking one of the research team 
• by sending an email to sponsor@uhs.nhs.uk, or  
• by ringing us on +44(0)23 8120 3598.  
 
 
Thank you for taking the time to read the information sheet and 
considering taking part in the research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
FRAIL2FIT 
 
   
 
xlv 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
Participant Information Sheet (Family Member/Carer) 
 
 
Study Title: The Frail2Fit Study: Online Nutrition and Exercise Support 
for Older Adults with Frailty 
 
Researcher: Dr Stephen Lim 
 
This project has been reviewed by the Wales REC 7 Research Ethics 
Committee. REC Reference: 22/WA/0155  
 
 
 
 
 
You are being invited to take part in the above research study. To help 
you decide whether you would like to take part or not, it is important 
that you understand why the research is being done and what it will 
involve. Please read the information below carefully and ask questions if 
anything is not clear or you would like more information before you 
decide to take part in this research.  You may like to discuss it with 
others but it is up to you to decide whether or not to take part. If you are 
happy to participate you will be asked to sign a consent form. 
 
What is the research about? 
 
I am a doctor specialising in the Care of Older People with an interest in 
improving the health of older people. This study aims to see if we can 
train volunteers to encourage older adults to exercise in a group and to 
provide them with nutrition support after being discharged from 
hospital. We also want to know if this is acceptable to them, and their 
family members. We will see if the exercise and nutrition support have 
an impact on the health of those taking part. This study is funded by the 
University Hospital Southampton Research and Development grants 
scheme and has been submitted to the NHS Health Research Authority 
research ethics committee for approval.  
 
Why have I been asked to participate? 
 

 
 
 
FRAIL2FIT 
 
   
 
xlvi 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
You have been asked to take part in this study because you are a family 
member or a carer of an older adult taking part in the online exercise and 
nutrition programme.  
 
What will happen to me if I take part? 
 
 
You will be invited to attend an interview to share your views and 
experiences on physical activity and nutrition support for frail older 
adults. We would like to find out your opinions on your family member, 
or client, taking part in the online nutrition and exercise support 
sessions to see what we can do to improve the delivery of the 
programme. Interviews will take place over the phone, or online (e.g., 
Zoom) depending on your personal preference. Interviews will be audio-
recorded. Your details will be anonymised (non-identifiable participant 
information), which means that no one outside the research team will 
know your name. People will read about the things you say to us, but 
they will not know who said those things.  
 
 
Are there any benefits in my taking part? 
 
By taking part in this study, you will help us better understand what we 
can do to improve the online exercise and nutrition support programme. 
This is an important step as we look to expand the programme in future 
studies. You will be contributing towards the improvement of health and 
care of older people.  
 
 
Are there any risks involved? 
 
There are minimal risks involved in this study. You will be interviewed by 
me on the telephone. The interview will be kept confidential, with your 
details anonymised. This study does not involve any invasive procedure. 
 
 

 
 
 
FRAIL2FIT 
 
   
 
xlvii 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
What data will be collected? 
 
You will be interviewed to explore your views and experiences about the 
exercise and nutrition programme. Interviews will be recorded using a 
digital audio-recorder. Participant information will be anonymised (non-
identifiable participant information) during the data analysis process and 
published data will not include any identifiable participant information.  
 
 
Will my participation be confidential? 
 
Your participation and the information we collect about you during the 
course of the research will be kept strictly confidential.  
 
Only members of the research team and responsible members of the 
University of Southampton may be given access to data about you for 
monitoring purposes and/or to carry out an audit of the study to ensure 
that the research is complying with applicable regulations. Individuals 
from regulatory authorities (people who check that we are carrying out 
the study correctly) may require access to your data. All of these people 
have a duty to keep your information, as a research participant, strictly 
confidential. 
 
Data collected will be entered electronically on the computer and stored 
on the university’s networked storage. Access to this information will be 
password-protected. Hard copies of participant information will be 
stored in a locked filing cabinet in a secure office in our research unit 
and will be accessible only by the research team. Audio recordings for 
the interviews will be deleted once they have been transcribed. Codes 
are allocated to each participant to ensure that the data is anonymised. 
Only the researchers in this study will have access to your data.  
 
In accordance with the regulations we are required to keep your data 
secure for 10 years.  
 
Your data may be used in future studies by our research team. If this 
happens, your data will be used anonymously (non-identifiable participant 

 
 
 
FRAIL2FIT 
 
   
 
xlviii 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
information) so you cannot be identified. Any new research studies using 
your data will be authorised by the local research ethics committee.   
 
Do I have to take part? 
 
No, it is entirely up to you to decide whether or not to take part. If you 
decide you want to take part, you will need to sign a consent form to 
show you have agreed to take part.  
 
Please inform me if you wish to take part and the research team will be 
in touch with you to provide you with more information and go through 
the consent process.   
 
What happens if I change my mind? 
 
You have the right to change your mind and withdraw at any time 
without giving a reason and without your participant rights being 
affected. Please inform the researcher if you wish to withdraw from the 
study.   
 
If you do not wish to carry on with this study, you can withdraw at any 
time without giving a reason. If you decide to withdraw we would like to 
retain the use of anonymised (non-identifiable participant information) 
routine data and any data already collected which would be important for 
the overall study results.  
 
What happens if I have given consent but then lose capacity to consent 
during the study? 
 
You and all your identifiable data collected during the study would be 
withdrawn from the study. Data which is not identifiable to the research 
team may be retained. 
 
 
What will happen to the results of the research? 

 
 
 
FRAIL2FIT 
 
   
 
xlix 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
 
Your personal details will remain strictly confidential. Research findings 
made available in any reports or publications will not include information 
that can directly identify you without your specific consent. The results of 
the research will be published in scientific journals.  Research staff may 
also present the results at conferences and local meetings, and on a 
website where it would be available to members of the public.  You will 
not be identified in any report produced. 
 
If you are interested, when we have finished analysing the study data, the 
research team will phone you to share the results. We will also place the 
study findings on a website (https://www.arc-wx.nihr.ac.uk/) 
and point you to any open access research publications. If you are 
interested but do not have access to the internet we can post the results 
upon request.  
 
Where can I get more information? 
 
For further information, please contact me (Dr Stephen Lim) at  
s.e.lim@soton.ac.uk, or by telephone 023 8120 6131. 
 
Or you can contact the research assistant Dr Samantha Meredith at 
s.j.meredith@soton.ac.uk, or by telephone 078 2510 4783. 
 
What happens if there is a problem? 
 
If you have a concern about any aspect of this study, you should speak 
to the researchers who will do their best to answer your questions.  
If you remain unhappy or have a complaint about any aspect of this 
study, please contact the University of Southampton Research Integrity 
and Governance Manager (023 8059 5058, rgoinfo@soton.ac.uk). 
 
NHS Indemnity Insurance 
 

 
 
 
FRAIL2FIT 
 
   
 
l 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
The University Hospital Southampton NHS Foundation Trust will act as 
sponsor for this research study and will provide insurance for the study 
through the NHS indemnity scheme. The insurance will meet the 
potential legal liability of the sponsor for harm to participants arising 
from the design of the research and the potential legal liability of 
investigators/collaborators arising from harm to participants in the 
conduct of the research. Moreover, volunteers will be insured by The 
Liabilities to Third Parties Scheme (LTPS) through NHS Resolutions. This 
will provide volunteers with employer’s liability, public liability, products 
liability, and professional indemnity cover. 
 
 
How will we use information about you?  
 
We will need to use information from you for this research project.  
This information will include your: 
• Name 
• Age 
• Address 
• Telephone number 
• Gender 
• Medical status 
 
People will use this information to do the research or to check your 
records to make sure that the research is being done properly. People 
who do not need to know who you are will not be able to see your name 
or contact details. Your data will have a code number instead.  
 
We will keep all information about you safe and secure.  
Once we have finished the study, we will keep some of the data so we 
can check the results. We will keep identifiable information about you for 
10 years after the study has finished after which time any link between 
you and your information will be removed and stored data will be 
destroyed. We will write our reports in a way that no-one can work out 
that you took part in the study. 
 

 
 
 
FRAIL2FIT 
 
   
 
li 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
What are your choices about how your information is used? 
• You can stop being part of the study at any time, without giving 
a reason, but we will keep information about you that we 
already have.  
• We need to manage your records in specific ways for the 
research to be reliable. This means that we won’t be able to let 
you see or change the data we hold about you.  
 
Where can you find out more about how your information is used? 
You can find out more about how we use your information  
• at www.hra.nhs.uk/information-about-patients/ 
• our leaflet available from www.hra.nhs.uk/patientdataandresearch 
• by asking one of the research team 
• by sending an email to sponsor@uhs.nhs.uk, or  
by ringing us on +44(0)23 8120 3598.  
 
 
 
Thank you for taking the time to read the information sheet and 
considering taking part in the research 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
FRAIL2FIT 
 
   
 
lii 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
Participant Information Sheet (Patient) 
 
 
Study Title: The Frail2Fit Study: Online Nutrition and Exercise Support 
for Older Adults with Frailty 
 
Researcher: Dr Stephen Lim 
 
This project has been reviewed by the Wales REC 7 Research Ethics 
Committee. REC Reference: 22/WA/0155 
 
 
 
 
 
 
You are being invited to take part in the above research study. To help 
you decide whether you would like to take part or not, it is important 
that you understand why the research is being done and what it will 
involve. Please read the information below carefully and ask questions if 
anything is not clear or you would like more information before you 
decide to take part in this research.  You may like to discuss it with 
others but it is up to you to decide whether or not to take part. If you are 
happy to participate you will be asked to sign a consent form. 
 
What is the research about? 
 
I am a doctor specialising in the Care of Older People with an interest in 
improving the health of older people. This study aims to see if we can 
train volunteers to encourage older adults to exercise in a group and to 
provide them with nutrition support after being discharged from 
hospital. We also want to know if this is acceptable to them, and their 
family members. We will see if the exercise and nutrition support have 
an impact on the health of those taking part. This study is funded by the 
University Hospital Southampton Research and Development grants 
scheme and has been submitted to the NHS Health Research Authority 
research ethics committee for approval.  
 
Why have I been asked to participate? 
 

 
 
 
FRAIL2FIT 
 
   
 
liii 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
You have been asked to take part in this study because you are due to be 
discharged from the University Hospital Southampton NHS Foundation 
Trust and you meet the eligibility criteria for this study. The inclusion 
criteria for this study are: anyone older than age 65, identified as frail, 
who can participate safely in the exercise programme, are able to walk at 
least a few steps upon hospital discharge, and are able to give consent.  
 
What will happen to me if I take part? 
 
Online exercise and nutrition support  
When you get home, you will be encouraged by volunteers to join in 
online home-based seated exercise and group nutrition support for 
twelve weeks. The volunteers delivering the programme have been 
trained by health professionals. In the first month you will be offered the 
opportunity to participate in 3 online sessions per week. Over time the 
number of sessions per week will reduce as you become more 
independent and learn how to complete the exercises.  
 
The exercises are done seated. They are simple to complete and are 
designed to maintain or improve your muscle strength. It is important 
that you move to where you feel comfortable and at your own pace. As 
you get a bit fitter the volunteers can offer you a resistance band. This is 
a long elastic band to get your muscles safely working a bit harder. The 
exercise is done online in a group with your peers.   
 
The nutrition support will involve friendly group discussion about diet 
and eating. The volunteers are not dieticians but they will be able to 
offer you direction to information that could help with eating well and 
feeling good.   
 
If you struggle to access the support online, we have an iPad (computer) 
you can borrow. We can also show you how to use the iPad and how to 
access the online sessions. Our research staff will be here to help you 
throughout the programme. If you do not feel comfortable using the 
online support then you can opt for telephone support instead.    
 
Evaluating the programme  

 
 
 
FRAIL2FIT 
 
   
 
liv 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
To find out if the online support works, we would like to learn about 
your health and well-being. We might also ask you some questions about 
your experiences participating in the programme.  
 
Before you leave hospital a research assistant, who is a healthcare 
professional, will collect some basic information about you. This will 
include measurements of your physical health, eating habits and activity 
levels with questionnaires. You will also be given an activity watch 
(accelerometer) to wear for 7 days when you get home. This watch will 
accurately measure your activity levels. After three months and six 
months, we will contact you again to repeat the measurements to 
determine the impact of the exercise and nutrition support on your 
health. The repeat data collection process will be done at your own home 
over the telephone and activity watches will be posted to you with a 
return pre-paid envelope.  
 
You may be invited to attend an interview to share your views and 
experiences on the exercise and nutrition support programme. 
Interviews will take place over the phone, or online (e.g., Zoom) 
depending on your preference. Interviews will be audio-recorded. If you 
do participate in an interview your details will be anonymised (non-
identifiable participant information), which means that no one outside 
the research team will know your name. People will read about the 
things you say to us, but they will not know who said those things.  
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
FRAIL2FIT 
 
   
 
lv 
Version 1.1 13th June 2022 [Ethics/IRAS number 309521] 
 
Timeline 
 
Completion of baseline 
questionnaires (30-40 mins) 
Month 1: 3 group sessions per 
week with volunteer (40-60 mins 
per session) 
Month 2: 2 group sessions per 
week with volunteer 
Month 3: 1 group session per 
week with volunteer & completion 
of questionnaires at end of 
programme (30-40 mins) 
Month 6: Follow-up 
questionnaires (30-40 mins) & 
wear an activity watch (7 days) 
Wear an activity watch (7 days) 
Possible Interview (30-60 mins) 

FRAIL2FIT 
1 
Version 1.1 13th June 2022  
 
Are there any benefits in my taking part? 
 
Studies have shown that exercise training and nutrition support 
are beneficial in improving physical function of older people. One 
of the benefits of taking part in this study is that you will be 
taught evidence-based exercises and nutrition advice which will 
be conducted in group online sessions. Exercising in an online 
group can also be a positive experience as the social aspect of 
group exercises has been shown to be a source of motivation.  
 
By taking part in this study, you will also be contributing to 
further research to improve the health of older people.    
 
 
Are there any risks involved? 
 
The risks involved in this study are minimal. Common injuries 
that may occur during exercises include muscle strain and back 
pain. To reduce the chances of any injuries you will be 
encouraged to exercise at your own pace to a level you feel 
comfortable with. The exercises are gentle seated movements and 
will be shown to you by friendly volunteers who have been trained 
by health professionals.  
 
Less commonly, is the risk of falls. However, the exercise 
programme is likely to help promote improvement in balance and 
muscle strength, which may help reduce the risk of falling. This 
study does not involve any invasive procedure. 
 
What will happen in case of an emergency? 
The volunteers will be taught how to deliver the support sessions 
safely. However, in the unlikely event that you require immediate 
medical attention (e.g., collapse) the volunteer will contact the 
emergency services. If you experience an adverse event (e.g., a 
muscle strain) then the volunteer will let us know (the study team) 
and we will get in contact with you to escalate the situation 
further, if required. Feel free to contact us if you have any worries 
or concerns during the programme. 

FRAIL2FIT 
2 
Version 1.1 13th June 2022  
 
 
What data will be collected? 
 
We will collect basic information such as your gender, date of 
birth, age, physical function status, and cognitive status. Using 
validated questionnaires, we will measure your physical activity 
levels, eating habits and well-being. These questionnaires will 
take approximately 30-40 minutes to complete with assistance 
from one of the research team. We will also measure your activity 
levels using an activity watch (accelerometer). These measures are 
important as it will help determine if the exercise and nutrition 
programme had a positive impact on your health. You may be 
invited to an interview to explore your views and experiences 
about the exercise and nutrition programme. Interviews will be 
recorded using a digital audio-recorder. 
 
Your contact details will be recorded to allow the research team 
to contact you at 3 and 6 months to re-do questionnaires. Your 
address will be recorded in case of an emergency during the 
exercise session. This will enable volunteers to notify the 
emergency services of where you are if needed.  
 
Your information will be anonymised (made non-identifiable) 
during the data analysis process and published data will not 
include any identifiable participant information.  
 
Will my clinical care team know if I want to participate in the 
study? 
 
If you decide to volunteer for the study, we will send a letter to 
your clinical care team to let them know that you are participating 
in the research if you consent to this in the consent form.  
 
Will the online sessions continue when the study has 
finished? 
 
The online support sessions will last 12 weeks during the study. 
There will be no further online support sessions when the study 

FRAIL2FIT 
3 
Version 1.1 13th June 2022  
 
has finished. However, you will be given resources, including 
booklets and access to online videos to continue with your 
exercise and nutrition changes at home in your own time.   
 
Will my participation be confidential? 
 
Your participation and the information we collect about you 
during the course of the research will be kept strictly confidential.  
 
Only members of the research team and responsible members of 
the University of Southampton may be given access to data about 
you for monitoring purposes and/or to carry out an audit of the 
study to ensure that the research is complying with applicable 
regulations. Individuals from regulatory authorities (people who 
check that we are carrying out the study correctly) may require 
access to your data. All of these people have a duty to keep your 
information, as a research participant, strictly confidential. 
 
Data collected will be entered electronically on the computer and 
stored on the university’s networked storage. Access to this 
information will be password-protected. Hard copies of 
participant information will be stored in a locked filing cabinet in 
a secure office in our research unit and will be accessible only by 
the research team. Audio recordings for the interviews will be 
deleted once they have been transcribed. Codes are allocated to 
each participant to ensure that the data is anonymised. Only the 
researchers in this study will have access to your data.  
 
In accordance with the regulations we are required to keep your 
data secure for 10 years.  
 
Your data may be used in future studies by our research team. If 
this happens, your data will be used anonymously (non-identifiable 
participant information) so you cannot be identified. Any new 
research studies using your data will be authorised by the local 
research ethics committee.   
 
 

FRAIL2FIT 
4 
Version 1.1 13th June 2022  
 
Do I have to take part? 
 
No, it is entirely up to you to decide whether or not to take part. If 
you decide you want to take part, you will need to sign a consent 
form to show you have agreed to take part.  
 
Please inform me if you wish to take part in this study and I will 
be in touch with you to provide you with more information and go 
through the consent process.   
 
 
What happens if I change my mind? 
 
You have the right to change your mind and withdraw at any time 
without giving a reason and without your participant rights being 
affected. Please inform the volunteer leading the sessions or me if 
you wish to withdraw from the study.   
 
If you do not wish to carry on with this study, you can withdraw at 
any time without giving a reason. If you decide to withdraw we 
would like to retain the use of anonymised (non-identifiable 
participant information) routine data and any data already collected 
which would be important for the overall study results.  
 
 
What happens if I have given consent but then lose capacity to 
consent during the study? 
 
You and all your identifiable data collected during the study 
would be withdrawn from the study. Data which is not identifiable 
to the research team may be retained. 
 
 
What will happen to the results of the research? 
 

FRAIL2FIT 
5 
Version 1.1 13th June 2022  
 
Your personal details will remain strictly confidential. Research 
findings made available in any reports or publications will not 
include information that can directly identify you without your 
specific consent. The results of the research will be published in 
scientific journals.  Research staff may also present the results at 
conferences and local meetings, and on a website where it would 
be available to members of the public.  You will not be identified 
in any report produced. 
 
If you are interested, when we have finished analysing the study 
data, the research team will phone you to share the results. We will 
also place the study findings on a website (https://www.arc-
wx.nihr.ac.uk/) 
and point you to any open access research publications. If you are 
interested but do not have access to the internet we can post the 
results upon request.  
 
 
Where can I get more information? 
 
For further information, please contact me (Dr Stephen Lim) at 
s.e.lim@soton.ac.uk, or by telephone 023 8120 6131. 
 
Or you can contact the research assistant Dr Samantha Meredith 
at s.j.meredith@soton.ac.uk, or by telephone 078 2510 4783. 
 
 
What happens if there is a problem? 
 
If you have a concern about any aspect of this study, you should 
speak to the researchers who will do their best to answer your 
questions.  
If you remain unhappy or have a complaint about any aspect of 
this study, please contact the University of Southampton Research 
Integrity and Governance Manager (023 8059 5058, 
rgoinfo@soton.ac.uk). 
 

FRAIL2FIT 
6 
Version 1.1 13th June 2022  
 
NHS Indemnity Insurance 
 
The University Hospital Southampton NHS Foundation Trust will 
act as sponsor for this research study and will provide insurance 
for the study through the NHS indemnity scheme. The insurance 
will meet the potential legal liability of the sponsor for harm to 
participants arising from the design of the research and the 
potential legal liability of investigators/collaborators arising from 
harm to participants in the conduct of the research. Moreover, 
volunteers will be insured by The Liabilities to Third Parties 
Scheme (LTPS) through NHS Resolutions. This will provide 
volunteers with employer’s liability, public liability, products 
liability, and professional indemnity cover. 
 
How will we use information about you?  
 
We will need to use information from you for this research 
project.  
This information will include your: 
• Name 
• Age 
• Address 
• Telephone number 
• Gender 
• Medical status 
 
People will use this information to do the research or to check 
your records to make sure that the research is being done 
properly. People who do not need to know who you are will not be 
able to see your name or contact details. Your data will have a 
code number instead.  
 
We will keep all information about you safe and secure.  
Once we have finished the study, we will keep some of the data 
so we can check the results. We will keep identifiable information 
about you for 10 years after the study has finished after which 
time any link between you and your information will be removed 
and stored data will be destroyed. We will write our reports in a 
way that no-one can work out that you took part in the study. 
 

FRAIL2FIT 
7 
Version 1.1 13th June 2022  
 
What are your choices about how your information is used? 
• You can stop being part of the study at any time, without 
giving a reason, but we will keep information about you 
that we already have.  
• We need to manage your records in specific ways for the 
research to be reliable. This means that we won’t be able 
to let you see or change the data we hold about you.  
 
Where can you find out more about how your information is 
used? 
You can find out more about how we use your information  
• at www.hra.nhs.uk/information-about-patients/ 
• our leaflet available from 
www.hra.nhs.uk/patientdataandresearch 
• by asking one of the research team 
• by sending an email to sponsor@uhs.nhs.uk, or  
by ringing us on +44(0)23 8120 3598.  
 
 
Thank you for taking the time to read the information sheet 
and considering taking part in the research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONSENT FORM  
 
Study title: The Frail2Fit Study: Online Nutrition and Exercise Support for Older 
Adults with Frailty 
 
Researcher name: Stephen Lim REC Reference: 22/WA/0155 
 
Participant Identification Number:  
 
Please initial the box(es) if you agree with the statement(s): 
 
 
I have read and understood the information sheet version ______ dated 
_______ and have had the opportunity to ask questions about the study. 
 
 
I agree to take part in this research project and agree for my data to be 
used for the purpose of this study. 
 
 
 
I understand my participation is voluntary and I may withdraw (at any 
time) for any reason without my participation rights being affected. 
 
 
 
I understand that should I withdraw from the study then the 
information collected about me up to this point may still be used for 
the purposes of research only.  
 
 
 
I agree to take part in the interview for the purposes set out in the 
participation information sheet and understand that these will be 
recorded using video or audio recording. 
 
 
 
I understand that my confidentiality as a participant in this study will 
remain secure and that the transcript of the interview will not contain 
 

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my name or identifiable information. I agree for my data to be stored 
anonymously and that any published quotations or extracts from the 
research will maintain my confidentiality. 
 
 
I understand that relevant sections of my medical notes and data 
collected during the study, may be looked at by individuals from 
University of Southampton study team, from regulatory authorities or 
from the NHS Trust, where it is relevant to my taking part in this 
research. I give permission for these individuals to have access to my 
records. 
 
 
 
I understand that my personal information collected about me such as 
my name or where I live will not be shared beyond the study team. 
 
 
I agree that anonymised data collected in this study may be used for 
future research by the study team. 
 
 
I would like my clinical care team to be notified that I am participating 
in this research. 
 
 
 
Name of participant (print name) ……………………….……………………………………… 
 
 
Signature of participant ….………………………………………………………………………. 
 
 
Date ………………………………………………………………………………………..………… 
 
 
 
 

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Name of researcher (print name) ….…………………………………………………………. 
 
 
Signature of researcher ...…………………………………………………………………………. 
 
 
Date …..……………………………………………………………………………………………….. 
 
 
 
[1 copy for the participant, 1 copy for the file] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Clinical Care Team Notification Letter 
 
UHS Frail2Fit Feasibility Study: A feasibility and acceptability study of a virtual 
multimodal intervention delivered by volunteers to improve functional 
outcomes of frail older adults discharged from hospital 
 
Dear UHS Clinical Care Team                                                                Date: XXX 
 
Your patient, XXX, has agreed to take part in the above feasibility study. This is a quasi-
experimental mixed methods feasibility study co-ordinated by the study management team 
at the University of Southampton and the research sponsor at University Hospital 
Southampton NHS Foundation Trust.  
 
This study aims to explore the feasibility and acceptability of training hospital 
volunteers to deliver an online multi-modal intervention, including exercise, 
behaviour change and nutrition support, to older people with frailty discharged from 
hospital.  
 
This study will involve your patient completing a 12-week volunteer-led online 
intervention, including evidence-based exercise training, nutrition and behaviour 
change support. We will assess your patient’s physical activity, appetite, physical 
function, well-being, anxiety and depression, and health self-management, using 
validated questionnaires at baseline, 3 months and 6 months post-intervention. We 
will also assess objective physical activity levels using an accelerometer for 7 days 
at baseline, 3 months, and 6 months. Your patient may also be asked for an 
interview to explore their experiences participating in the intervention.  
 
Your patient has been provided with verbal and written information for the study 
(copy enclosed) which explains why s/he has been approached to take part in the 
research, that the participation is entirely voluntary, and emphasises that they are 
free to withdraw from the study at any time without prejudicing their future medical 
care.  
 
Should you have any questions or require further information about this research, 
please do not hesitate to contact the chief investigator in charge of the local study.  
 
Dr Stephen Lim, Consultant Geriatrician, Academic Geriatric Medicine, University Hospital 
Southampton NHS FT, Tremona Road, Southampton, SO16 6YD Telephone: 
02381206131. Email: s.e.lim@soton.ac.uk 
 
 
Yours sincerely,  
 
Dr Samantha Jane Meredith 
 
Research Fellow 
University of Southampton 
Academic Geriatric Medicine 
s.j.meredith@soton.ac.uk  

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University Hospital Southampton NHS Foundation Trust  
Scientific Peer Review Form 
 
PROJECT TITLE 
 
Frail2Fit 
 
CHIEF INVESTIGATOR 
Stephen Lim 
 
STUDENT (if applicable) 
 
 
 
All studies which are requesting sponsorship from University Hospital Southampton NHS 
Foundation Trust will require two supporting peer reviews to assist in the verification of the 
scientific quality and robustness of the study. 
 
Please note no internal peer review is required for projects where an external body is 
undertaking a review as part of a funding application but should include confirmation 
of the funding award with the Sponsorship request. 
 
SCIENTIFIC QUALITY PEER REVIEW 
ASSESSMENT CRITERIA 
YES 
NO 
UNCLEAR 
N/A 
1. Study Design 
 
 
 
 
Does the research have a clear protocol? 
 
 
 
 
Is the research question or hypothesis clearly stated? 
 
 
 
 
Are the project objectives described? 
 
 
 
 
Are the objectives realistic? 
 
 
 
 
Has other relevant research been reviewed? 
 
 
 
 
Is the methodology appropriate to the research question? 
 
 
 
 
Have the methods of measurement been described? 
 
 
 
 
Has the reliability and validity of measurement been 
reviewed? 
 
 
 
 

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If available, are validated scales of measurement being 
used? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
 
2. Study sample and data analysis 
 
 
 
 
Is the proposed population group appropriately 
representative? 
 
 
 
 
Is the sample size justified and realistic? 
 
 
 
 
Are the methods of data analysis (statistical or otherwise) 
described and appropriate? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
 
3. Impact and importance 
 
 
 
 
Are the expected values and benefits of the research clear? 
 
 
 
 
Will the research add to current knowledge or have training 
value? 
 
 
 
 
Is the research generalisable i.e. have potential application 
beyond the Trust? 
 
 
 
 
Will the findings lead to significant health gains and/or benefit 
the Trust/ NHS/ population? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 

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4. Dissemination 
 
 
 
 
Do the researchers intend to disseminate research findings 
in an appropriate journal ? 
 
 
 
 
Will the results of the research be made available to 
research participants? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
5. Feasibility 
 
 
 
 
Is the research feasible within the local context? 
 
 
 
 
Is the project feasible within the timeframe and resources 
proposed? 
 
 
 
 
Is the proposed research likely to put the Trust, Trust staff, 
participants in the research or the applicants at risk, which 
are such that these should specifically be taken into account 
when deciding whether or not to support the research? 
 
 
 
 
Where relevant, has a multidisciplinary and multi-
professional approach to addressing the research question 
been adopted? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 
 
 
6. Consumer Involvement 
 
 
 
 
Where relevant, have patients or their representatives been 
involved in this project? 
 
 
 
 
If No or Unclear has been marked for any of the above then please elaborate: 
 
 

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OVERALL RATING 
(Scale of 1-5 were 1 indicates poor, 3 acceptable and 5 excellent) 
4 
 
Overall Comments 
Please provide comments you may wish to make on the proposal, particularly any 
suggestions as to how the project could be amended.  Your comments will be used to 
provide feedback to the Principal Investigator. 
 
 
Very interesting study proposal!  
It would be useful to perhaps explain further the intervention for each session, i.e. how 
long is it session, will all components be delivered each session or one component 
session etc.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REVIEWER 
RECOMMENDATION 
 
Approve: 
 
 
 
Approve with amendments described above: 
 
 
 

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Version 1.1 13th June 2022  
 
 
 
Resubmit after amendments described above:     
 
 
 
 
Reject: 
 
 
 
Signature: 
(please provide a physical 
signature and not a copy of a 
scanned example) 
 
 
Printed Name:  
 
 
Dr Qian Yue Tan 
Job Title & 
Organisation:  
 
Clinical Research Fellow and Specialty Registrar in Geriatric 
Medicine, University Hospital Southampton NHS FT 
Date: 
21st February 2022  
 
 
 
 
 
 
 
 
 
 
 

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Section 1 (to be completed with volunteers)  
 
  
 
1. Do you have any previous volunteering experience?    
Yes 
 
No 
a. and if so how many years?   
 
 
 
2. Do you have any previous experience delivering group exercises?    Yes  
 
No  
a.  
and if so how many years?    
 
 
3. Why did you choose to become a Frail2Fit volunteer? 
 
 
 
4. Gender:   
 
 
Male  □   
Female  □ 
Other  □ 
 
5. Ethnicity:   
 
…………………………………………………………………………………………………
………… 
6. Marital status: 
Single  □ 
Married  □ 
Divorced/Separated  □ 
 
 
 
               Widowed  □          Cohabiting    □            
7. DOB: 
  
 
…………………………………………………………………………………………………
………… 
8. Employment status: Employed: Part-time  □  
Full-time  □    
Unemployed  □    
Retired  □    Student  □    Other □ 
………………………………………………… 
 
Section 2 (to be completed by Research staff)  
 
 
 
1. Date attended training:
 
…………………………………………………………………………………… 
2. Date competencies achieved: 
 
…………………………………………………………………………………… 
3. Date started as Frail2Fit volunteer 
:…………………………………………………………………………………… 
Supervision required for confidence: Minimal  □ 
Moderate  □ Constant  □  
Supervision required for safety: 
Minimal  □ 
Moderate  □ Constant  □  
4. Number of interventions 
conducted:…………………………………………………………………………………… 
5. Date ceased as Frail2Fit volunteer:
 
…………………………………………………………………………………… 
6. Reasons for leaving: 
 
 
…………………………………………………………………………………… 
Collection sheet completed by: 
 
…………………………………………………………………………………… 
Date completed: 
 
 
…………………………………………………………………………………… 
 
 
 
 

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Version 1.1 13th June 2022  
 
Date Information Collected: 
 
 
 
 
 
 
 
d 
d 
m 
m 
y 
y 
Gender:  
Male = 0 
Female = 
1  
 
 
 
 
 
 
 
Date of Birth: 
 
 
 
 
 
 
 
d 
d 
m 
m 
y 
y 
    
 
SOCIAL CIRCUMSTANCES 
 
 
Marital status: 
Single = 1 
Married = 2 
Divorced or separated = 3  
Widowed = 4 
Cohabiting = 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
Usual Residence: 
Private home living alone = 1 
Private home living with friends or relatives = 2 
Sheltered accommodation = 3 
Residential/Rest Home = 4 
Nursing Home = 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Care provision: 
o No care required     = 0 
o Informal provision = 1 
o Formal provision     = 2 
 
 
 
 
Tobacco and alcohol consumption: 
 
 
 
 
 
 
Smoking 
Never = 
1 
Ex = 2 
Current = 3 
 
 
 
 
 
 
 
 
 
Cigarette pack years 
 
 
 
 
 
 
 
 
Alcohol units per week 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Version 1.1 13th June 2022  
 
Clinical Frailty Scale 
 
Frailty Score:  
≥5 for study inclusion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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EuroQol EQ-5D-5L 
Under each heading, please tick the ONE box that best describes your health 
TODAY 
 
 
Mobility 
 
I have no problems in walking about 
❑ 
I have slight problems in walking about 
❑ 
I have moderate problems in walking about 
❑ 
I have severe problems in walking about 
❑ 
I am unable to walk about 
❑ 
 
 
Self-Care 
 
I have no problems washing or dressing myself 
❑ 
I have slight problems washing or dressing myself 
❑ 
I have moderate problems washing or dressing myself 
❑ 
I have severe problems washing or dressing myself 
❑ 
I am unable to wash or dress myself 
❑ 
 
 
Usual Activities (e.g. work, study, housework, family or leisure 
activities) 
 
I have no problems doing my usual activities 
❑ 
I have slight problems doing my usual activities 
❑ 
I have moderate problems doing my usual activities 
❑ 
I have severe problems doing my usual activities 
❑ 
I am unable to do my usual activities 
❑ 
 
 
Pain / Discomfort 
 
I have no pain or discomfort 
❑ 
I have slight pain or discomfort 
❑ 
I have moderate pain or discomfort 
❑ 
I have severe pain or discomfort 
❑ 
I have extreme pain or discomfort 
❑ 
 
 
Anxiety / Depression 
 
I am not anxious or depressed 
❑ 
I am slightly anxious or depressed 
❑ 
I am moderately anxious or depressed 
❑ 
I am severely anxious or depressed 
❑ 
I am extremely anxious or depressed 
❑ 
 
 
 

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9 0 
8 0 
7 0 
6 0 
5 0 
4 0 
3 0 
2 0 
1 0 
100 
0 
 
 
 
 
 
 
• We would like to know how good or bad your 
health is TODAY 
• The scale is numbered from 0 to 100 
• 100 means the best health you can imagine 
• 0 means the worst health you can imagine 
• Mark an X on the scale to indicate how your health 
is TODAY 
• Now, please write the number you marked on the 
scale in the box below 
 
 
 
 
 
YOUR HEALTH TODAY =  
 
 
 
 
 
 
 
 
 
 
 
 
The best health 
you can imagine 
The worst heath 
you can 
imagine 

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Version 1.1 13th June 2022  
 
Mini Mental State Examination 
 
 
 
 
 
ORIENTATION 
 
 
Year 
Month 
Day 
Date 
Time 
__/5 
 
Country 
Town 
District 
Hospital 
Ward 
__/5 
REGISTRATION 
 
 
 
Examiner names 3 objects (eg apple, table, penny)  
Patient asked to repeat (1 point for each correct) 
THEN patient to learn the 3 names repeating until correct 
__/3 
ATTENTION AND CALCULATION 
 
 
Subtract 7 from 100,  then repeat from result. 
Continue 5 times:  100  93 86  79  72  65 
Alternative: spell "WORLD" backwards - dlrow. 
__/5 
RECALL 
 
 
Ask for names of 3 objects learned earlier. 
__/3 
 
 
 
LANGUAGE 
 
Name a pencil and a watch 
__/2 
Repeat “No ifs, ands or buts” 
__/1 
Give a 3 stage command.  Score 1 for each stage. 
Eg. "Place index finger of right hand on your nose and then on your left 
ear". 
__/3 
Ask patient to read and obey a written command on a piece of paper 
stating "Close your eyes". 
__/1 
Ask the patient to write a sentence. Score if it is sensible and has a 
subject and a verb. 
__/1 
 
 
 
COPY 
Ask the patient to copy a pair of intersecting pentagons: 
 
__/1 
 
 
 
Total: __/30 
 
 
 
 
 
 
 

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Charlson Co-morbidity Index 
Score ‘0’ if the disease is not present.  
Active co- morbidities 
Score 
Myocardial infarction (+1) 
 
Congestive Cardiac Failure (+1) 
 
Peripheral vascular disease (+1) 
 
Cerebrovascular accident or Transient Ischaemic Attack 
(+1) 
 
Dementia (+1) 
 
Chronic Obstructive Pulmonary Disease (+1) 
 
Connective tissue disease (+1) 
 
Peptic ulcer disease 
 
Liver disease 
• None (0) 
• Mild (+1) 
• Moderate to severe (+3) 
 
Diabetes mellitus 
• None or diet-controlled (0) 
• Uncomplicated (+1) 
• End-organ damage (+2) 
 
Hemiplegia (+2) 
 
Moderate to severe Chronic Kidney Disease (moderate = 
creatinine > 265 micromol/L (+2) 
 
Solid tumour 
• None (0) 
• Localised (2) 
• Metastatic (6) 
 
Leukeamia (+2) 
 
Lymphoma  (+2) 
 
AIDS (+6) 
 
Age  
• < 50 years (0) 
• 50-59 years (+1) 
• 60-69 years (+2) 
• 70-79 years(+3) 
• ≥ 80 years (+4) 
 
Total score  
 
 
Number of medications: 
 

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NUTRITIONAL INDICES (self-reported) 
Height, Weight and Body Mass Index 
 
Date Measured: 
 
 
 
 
 
 
 
d 
d 
m 
m 
y 
y 
 
Height (cm) 
 
 
 
 
 
Weight (kg) 
 
 
 
 
• 
 
 
BMI (kgm-2) 
 
 
 
 
• 
 
 
 
 
 
 
 
 
MUST Score: 
 
ACCELEROMETER  
 
Date of device applied :  
 
Date of device removed : 
 
 
Total number of days : 
 
 
 
 
 
 
 
 
 
Reason for early removal of device: 
 
No. of Hospital Readmissions:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
d 
d 
m 
m 
y 
y 
 
 
 
 
 
 
d 
d 
m 
m 
y 
y 

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Barthel Index 
Bowels 
incontinent (or needs to be given enema)  
occasional accident (once/week) 
continent  
 
0 
1 
2 
Bladder 
incontinent, or catheterized and unable to manage  
occasional accident (max. once per 24 hours) 
continent (for over 7 days)  
 
0 
1 
2 
Grooming 
needs help with personal care 
independent face/hair/teeth/shaving (implements provided)  
 
0 
1 
Toilet Use 
dependent 
needs some help, but can do something alone  
independent (on and off, dressing, wiping)  
 
 
0 
1 
2 
Feeding 
unable 
needs help cutting, spreading butter, etc. 2 = independent (food provided within 
reach)  
 
0 
1 
Transfer 
unable – no sitting balance 
major help (one or two people, physical), can sit  
minor help (verbal or physical) 
independent  
 
0 
1 
2 
3 
Mobility 
Immobile 
wheelchair independent, including corners, etc. 
walks with help of one person (verbal or physical) 
independent (but may use any aid)  
 
0 
1 
2 
3 
Dressing 
dependent 
needs help, but can do about half unaided 
independent (including buttons, zips, laces etc)  
 
0 
1 
2 
Stairs 
unable 
needs help (verbal, physical, carrying aid) 
independent up and down  
 
0 
1 
2 
Bathing 
dependent 
independent (or in shower)  
 
 
0 
1 
Total Score:  

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PASE 
Leisure Time Activity 
1. Over the past 7 days, how often did you participate in sitting activities such as 
reading, watching TV, or doing handcrafts? 
 
0) Never (go to question 2) 
1) Seldom (1-2 days) (go to question 1a and 1b) 
2) Sometimes (3-4 days) (go to question 1a and 1b) 
3) Often (5-7 days) (go to question 1a and 1b) 
1a. What were these activities ? 
 
1b. On average, how many hours did you engage in these sitting activities ?  
0) Less than 1 hour 
1) 1-1.9 hours 
2) 2-4 hours 
3) >4 hours 
 
2. Over the past 7 days, how often did you take a walk outside your home or 
yard for any reason? For example, for fun or exercise, walking to work, 
walking the dog, etc 
 
0) Never  (go to question 3) 
1) Seldom (1-2 days) (go to question 2a) 
2) Sometimes (3-4 days) (go to question 2a) 
3) Often (5-7 days) (go to question 2a) 
 
2a. On average, how many hours per day did you spend walking ? 
 
0) Less than 1 hour 
1) 1-1.9 hours 
2) 2-4 hours 
3) >4 hours 
 
 
3. Over the past 7 days, how often did you engage in light sport or recreational 
activities such as bowling, golf with a cart, shuffleboard, fishing from a boat or 
pier or other similar activities? 
 
0) Never (go to question 4) 
1) Seldom (1-2 days) (go to question 3a and 3b) 
2) Sometimes (3-4 days) (go to question 3a and 3b) 
3) Often (5-7 days) (go to question 3a and 3b) 
3a. What were these activities ? 
3b. On average, how many hours did you engage in these light sport or recreational 
activities?  
 
0) Less than 1 hour 
1) 1-1.9 hours 

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2) 2-4 hours 
3) >4 hours 
 
4. Over the past 7 days, how often did you engage in moderate sport and 
recreational activities such as doubles tennis, ballroom dancing, hunting, ice 
skating, golf without a cart, softball or other similar activities? 
 
0) Never (go to question 5) 
1) Seldom (1-2 days) (go to question 4a and 4b) 
2) Sometimes (3-4 days) (go to question 4a and 4b) 
3) Often (5-7 days) (go to question 4a and 4b) 
 
 
4a. What were these activities ? 
 
 
4b. On average, how many hours did you engage in these moderate sports or 
recreational activities ? 
 
0) Less than 1 hour 
1) 1-1.9 hours 
2) 2-4 hours 
3) >4 hours 
 
 
 
 
 
5. Over the past 7 days, how often did you engage in strenuous sport and 
recreational activities such as jogging, swimming, cycling, singles tennis, 
aerobic dance, skiing (downhill or cross-country) or other similar activities? 
 
0) Never (go to question 6) 
1) Seldom (1-2 days) (go to question 5a and 5b) 
2) Sometimes (3-4 days) (go to question 5a and 5b) 
3) Often (5-7 days) (go to question 5a and 5b) 
 
5a. What were these activities? 
 
5b. On average, how many hours did you engage in these strenuous sport or 
recreational activities? 
 
0) Less than 1 hour 
1) 1-1.9 hours 
2) 2-4 hours 
3) >4 hours 
 

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6. Over the past 7 days, how often did you do any exercises specifically to 
increase muscle strength and endurance, such as lifting weights or pushups, 
etc.? 
 
0) Never (go to question 7) 
1) Seldom (1-2 days) (go to question 6a and 6b) 
2) Sometimes (3-4 days) (go to question 6a and 6b) 
3) Often (5-7 days) (go to question 6a and 6b) 
6a. What were these activities ? 
 
6b. On average, how many hours did you engage in these exercises to increase 
muscle strength ? 
 
0) Less than 1 hour 
1) 1-1.9 hours 
2) 2-4 hours 
3) >4 hours 
Household Activity 
7. During the past 7 days, have you done any light housework, such as dusting 
or washing dishes? 
1) No 
2) Yes 
8. During the past 7 days, have you done any heavy housework or chores, such 
as vacuuming, scrubbing floors, washing windows, or carrying wood? 
1) No 
2) Yes 
 
9. During the past 7 days, did you engage in any of the following activities? 
Please answer YES or NO for each item. 
 
a) Home repairs like painting, wallpapering, electrical work, etc. 
b) Lawn work or yard care, including snow or leaf removal, wood chopping, etc. 
c) Outdoor gardening 
d) Caring for another person, such as children, dependent spouse, or another 
adult 
 
Work-Related Activity 
10. During the past 7 days, did you work for pay or as a volunteer? 
 
1) NO 
2) YES (go to questions 10a and 10b) 
 
10a. How many hours per week did you work for pay and or as a volunteer? ____ 
hours 
 
10b. Which of the following categories best describes the amount of physical activity 
required on your job and or volunteer work? 

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1) Mainly sitting with some slight arm movement (Examples: office worker, 
watchmaker, seated assembly line worker, bus driver, etc.) 
2) Sitting or standing with some walking (Examples: cashier, general office 
worker, light tool and machinery worker) 
3) Walking with some handling of materials generally weighing less than 50 
pounds (Examples: mailman, waiter/waitress, construction worker, heavy tool 
and machinery worker) 
4) Walking and heavy manual work often requiring handling of materials 
weighting over 50 pounds (Ex: lumberjack, stone mason, farm or general 
labourer)

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Short Nutritional Assessment Questionnaire (SNAQ) 
1. My appetite is: 
a. Very Poor 
b. Poor 
c. Average 
d. Good 
e. Very Good 
 
2. When I eat: 
a. I feel full after eating only a few mouthfuls 
b. I feel full after eating about a third of a meal 
c. I feel full after eating over half a meal 
d. I feel full after eating most of the meal 
e. I hardly ever feel full 
 
3. Food tastes: 
a. Very bad 
b. Bad 
c. Average 
d. Good  
e. Very good 
 
4. Normally I eat: 
a. Less than one meal a day 
b. One meal a day 
c. Two meals a day 
d. Three meals a day 
e. More than three meals a day 
 
 
Total Score: _________/20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Warwick-Edinburgh Well-Being Scale (WEMWBS) 
 
None of the 
time 
Rarely 
Some of 
the time 
Often 
All of the 
time 
I’ve been feeling optimistic 
about the future 
 
1 
2 
3 
4 
5 
I’ve been feeling useful 
 
1 
2 
3 
4 
5 
I’ve been feeling relaxed 
 
1 
2 
3 
4 
5 
I’ve been feeling interested 
in other people 
 
1 
2 
3 
4 
5 
I’ve had energy to spare 
 
1 
2 
3 
4 
5 
I’ve been dealing with 
problems well 
 
1 
2 
3 
4 
5 
I’ve been thinking clearly 
 
1 
2 
3 
4 
5 
I’ve been feeling good 
about myself 
 
1 
2 
3 
4 
5 
I’ve been feeling close to 
other people 
 
1 
2 
3 
4 
5 
I’ve been feeling confident 
 
1 
2 
3 
4 
5 
I’ve been able to make up 
my own mind about things 
 
1 
2 
3 
4 
5 
I’ve been feeling loved 
 
1 
2 
3 
4 
5 
I’ve been interested in new 
things 
 
1 
2 
3 
4 
5 
I’ve been feeling cheerful 
 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 

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Hospital Anxiety and Depression Scale (HADS) 
 
 
 
Total Score: Depression (D) _____________________    
Anxiety (A) ___________________________ 
 
 

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Self-efficacy for managing chronic disease 
We would like to know how confident you are in doing certain activities. For each of the 
following questions, please choose the number that corresponds to your confidence that you 
can do the tasks regularly at the present time. 
 
 
1. How confident do you feel that you 
can keep the fatigue caused by your  
disease from interfering with the 
things you want to do? 
 
2. How confident do you feel that you 
can keep the physical discomfort or 
pain of your disease from interfering 
with the things you want to do? 
 
3. How confident do you feel that you 
can keep the emotional distress 
caused by your disease from 
interfering with the things you want 
to do? 
 
4. How confident do you feel that you 
can keep any other symptoms or 
health problems you have from 
interfering with the things you want 
to do? 
 
5. How confident do you feel that you 
can do the different tasks and 
activities 
needed to manage your health 
condition so as to reduce your need 
to see a doctor? 
 
6. How confident do you feel that you 
can do things other than just taking 
medication to reduce how much your 
illness affects your everyday life? 
 
 
SCORE _______________ 
 
 
 
 

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Frail2Fit study  
Semi-structured interview schedule for volunteers 
1. Tell me your views about being physically active in general. 
a. Explore general perception on physical activity 
b. What are the potential benefits? 
c. Any potential harm? 
 
2. In your view, what are the things/factors that could discourage older people to be more 
active? 
a. Explore environmental factors, motivation, cost, accessibility, fear of injury/falls 
and any other additional factors 
 
3. What are the things/factors that could encourage older people to be more active? 
a. Explore environment, social support, interest, accessibility and any other 
additional factors 
b. Explore types of physical activity which older people are more likely to engage 
with, including frequency, and duration. 
 
4. What are your general views about diet / nutrition for older people?  
a. Explore general perception on nutrition and eating 
b. What are the potential benefits for older adults following a healthy eating pattern? 
c. Are there any drawbacks, or disadvantages from altering diet / nutrition? 
 
5. In your view what are the things that could encourage older people to eat healthily?  
a.  Explore food acquisition and preparation 
b. Explore nutritional knowledge, environment, social support, interest 
c. Explore types of foods that older people may prefer to eat  
 
6. In your view what discourages older people from eating healthily?  
a. Explore social and environmental factors e.g., cost of food, lack of help in preparing 
meals 
b. Explore appetite, taste preferences and dietary habits 
 
7. What motivated you to volunteer for the role? 
 
8. What are your views on the use of trained volunteers to deliver group exercise and 
nutrition support to older people in the community? 
a. Can you describe your experience with these classes? Any advantages or 
disadvantages? 

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b. What was good about these groups? And what things do you think need 
improvement? 
c. What were the benefits? 
d. Were there negative experiences? 
 
9. In your view, what has it been like as a volunteer encouraging participants to be more 
active?  
a. Explore if it worked for some but not others, including reasons for this. 
 
10. In your view, what has it been like as a volunteer delivering the nutrition wheel and 
encouraging participants to eat healthily? 
a. Explore if it worked for some but not others, including reasons for this. 
 
11. What were your experiences with the volunteer training? 
a. Explore training content and timing 
b. Explore opinions regarding training resources, such as booklets and videos 
c. Explore if any improvements are needed for volunteer training 
d. Explore their perceptions of available support e.g., support given, impact on 
confidence levels, availability of peer support  
 
12. Do you have any suggestions or comments about the intervention? 
a. Explore things that went well 
b. Explore things that could be improved 
 
13. What were your experiences with delivering the support online? 
a. Explore any barriers to accessing, or using the online intervention e.g., tech 
knowledge, general perceptions of using technology, any misconceptions regarding 
online platforms, visibility and sound during sessions 
b. Explore the things that helped / facilitated use of online tech  
 
14. In your opinion, how could these volunteer-led sessions be continued and extended to 
other clubs? 
a. Explore participants views on barriers and facilitators to the implementation of 
the intervention in other settings 
 
15. How can we improve the volunteering experience for future volunteers in this 
intervention?  
a. Explore factors to aid retention and recruitment of others  
 

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Frail2Fit study  
Semi-structured interview schedule for patients 
1. Since being discharged from hospital how have things been going for you at home? 
a. Could you explain what a typical day is like for you? (Build rapport and understand 
what life is like for them) 
b. Explore functional capacity 
c. Explore meaningful activities and general day to day motivation 
d. Explore any concerns or barriers to recovery post-discharge  
 
2. Tell me your views about being physically active in general. 
b. Explore general perception on physical activity 
c. What are the potential benefits? 
d. Any potential harm? 
 
3. In your view, what are the things/factors  that could discourage older people to be more 
active? 
a. Explore environmental factors, motivation, cost, accessibility, fear of injury/falls  
 
4. What are the things/factors that could encourage older people to be more active? 
a. Explore environment, social support, interest, accessibility 
b. Explore types of physical activity which older people are more likely to engage 
with, including frequency, and duration. 
 
5. What are your general views about diet / nutrition? What is your eating and diet like? 
d. Explore general perception on nutrition and eating 
e. What are the potential benefits of following a healthy eating pattern? 
f. Are there any drawbacks, or disadvantages from altering diet / nutrition? 
 
6. In your view what are the things that could encourage older people to eat healthily? 
What helps you to eat more healthily? 
d.  Explore food acquisition and preparation 
e. Explore nutritional knowledge, environment, social support, interest 
f. Explore types of foods that older people may prefer to eat  
 
7. In your view what discourages older people to eat healthily? What stops you eating 
more healthily? 
c. Explore social and environmental factors e.g., cost of food, lack of help in preparing 
meals 
d. Explore appetite, taste preferences and dietary habits 

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8. What are your views on the use of trained volunteers to deliver group exercise and 
nutrition support to older people in the community? 
a. Can you describe your experience with these exercise and nutrition sessions? 
Any advantages or disadvantages? 
b. What was good about these groups? And what things do you think need 
improvement? 
c. What were the benefits? 
d. Were there negative experiences? 
 
9. In your view, how effective were the trained volunteers at delivering the exercises and 
encouraging participants to be more active? 
 
10.  In your view, how effective were the trained volunteers at delivering the nutrition wheel 
and encouraging participants to eat healthily? 
 
11. Do you have any suggestions or comments about the intervention? 
a. Explore things that went well 
b. Explore things that could be improved 
 
12. What were your experiences with using the device and receiving the support online? 
c. Explore any barriers to accessing, or using the online intervention e.g., tech 
knowledge, general perceptions of using technology, any misconceptions regarding 
online platforms, visibility and sound during sessions 
d. Explore the things that helped / facilitated use of online tech  
 
13. In your opinion, how could these volunteer-led sessions be continued and extended to 
other clubs? 
c. Explore participants views on barriers and facilitators to the implementation of 
the intervention in other settings 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Frail2Fit study  
Semi-structured interview schedule for family members 
1. Since being discharged from hospital how have things been going for your family 
member at home? 
e. Could you explain what a typical day is like for them? (Build rapport and understand 
what life is like for them) 
f. Explore functional capacity 
g. Explore meaningful activities and general day to day motivation 
h. Explore any concerns or barriers to recovery post-discharge  
 
2. Tell me your views about being physically active in general. 
e. Explore general perception on physical activity 
f. What are the potential benefits? 
g. Any potential harm? 
 
3. In your view, what are the things/factors  that could discourage older people to be more 
active? 
a. Explore environmental factors, motivation, cost, accessibility, fear of injury/falls  
 
4. What are the things/factors that could encourage older people to be more active? 
c. Explore environment, social support, interest, accessibility 
d. Explore types of physical activity which older people are more likely to engage 
with, including frequency, and duration. 
 
5. What are your general views about diet / nutrition? What is your family member’s 
eating and diet like? 
g. Explore general perception on nutrition and eating 
h. What are the potential benefits of following a healthy eating pattern? 
i. Are there any drawbacks, or disadvantages from altering diet / nutrition? 
 
6. In your view what are the things that could encourage older people to eat healthily? 
What helps your family member to eat more healthily? 
g.  Explore food acquisition and preparation 
h. Explore nutritional knowledge, environment, social support, interest 
i. Explore types of foods that older people may prefer to eat  
 
7. In your view what discourages older people to eat healthily? What stops your family 
member eating more healthily? 

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e. Explore social and environmental factors e.g., cost of food, lack of help in preparing 
meals 
f. Explore appetite, taste preferences and dietary habits 
  
8. What are your views on the use of trained volunteers to deliver group exercise and 
nutrition support to older people in the community? 
e. Can you describe your family member’s experience with these exercise and 
nutrition sessions? Any advantages or disadvantages? 
f. What was good about these groups? And what things do you think need 
improvement? 
g. What were the benefits? 
h. Were there negative experiences? 
 
9. In your view, how effective were the trained volunteers at delivering the exercises and 
encouraging your family member to be more active? 
a. Explore impact of the exercise programme on family members health and 
activity levels. 
b. Explore positive and negative experiences of the intervention. 
 
10.  In your view, how effective were the trained volunteers at delivering the nutrition wheel 
and encouraging your family member to eat healthily? 
a. Explore impact of the nutrition programme on family members health and eating 
behaviours. 
b. Explore positive and negative experiences of the intervention. 
 
11. Do you have any suggestions or comments about the intervention? 
d. Explore things that went well 
e. Explore things that could be improved 
 
12. What are your views on your family member using online tech to access the 
intervention?  
e. Explore any barriers to accessing, or using the online intervention e.g., tech 
knowledge, general perceptions of using technology, any misconceptions regarding 
online platforms, visibility and sound during sessions 
f. Explore the things that helped / facilitated use of online tech  
 
13. In your opinion, how could these volunteer-led sessions be continued and extended to 
other clubs? 
a. Explore participants views on barriers and facilitators to the implementation of 
the intervention in other settings 
 
 

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Screening and Escalation Plan 
 
Screening at the start of each support session 
(5 – 10 minutes) 
 
• Exercise: It is essential to use Table 1 (Exercise Screening at each 
Session)to identify any changes in participant-specific considerations (or 
comorbidities)and if necessary, to take the appropriate action defined in 
Figure 1 (Escalation Process). Please also report any actions taken or 
concerns to the Frail2Fit team on (insert number here), or (insert email 
here). 
• Nutrition: Any marked change in appetite, eating habits (including change 
inability to eat or drink) and perceived unintended weight loss: Do not 
exercise and notify trial team on (insert number and email here). 
• Medications: If participant has started any new medications, report this to 
the Frail2Fit team. Ensure patient has taken prescribed medications as 
normal. If they haven’t contact the Frail2Fit team on (insert number and 
email here). 
 
If a concern arises please refer to the SAFETY ESCALATION PROCESS 
outlined in Figure 1. 
 
Table 1. Exercise Screening at each Session 
 
Has the participant been experiencing any of the following? 
Delayed onset muscle soreness 
If yes, observe and modify exercises accordingly 
Has the participant experienced any of the following?  
Contacted GP  
Visited A&E  
Been admitted to hospital?  
If yes, please contact Frail2Fit trial team before delivering the exercise 
support session.  
Has the participant experienced any of the following?  
Fever or infection  
Nausea, vomiting or diarrhea  
Recent dizziness or fainting  

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Any new or worsening of symptoms (e.g., pain) 
If yes, no exercise – alert trial team  
Emergency Scenario  
Chest, arm or jaw pain Dial 999  
Anything that the instructor feel’s is an emergency  
When appropriate please alert the Frail2Fit team  
 
Safety Escalation 
 
Based on your screening results you may need to escalate to the trial team for 
further advice before proceeding with your session – if this is the case please 
record this in your session completion log.  
There may also be circumstances where you need to escalate during or after 
your session as outlined in Figure 1.  
 
Patient safety is our highest priority, so if you have any concerns or doubts, 
please just call us.  
 
KEY REMINDER: Please remember to alert the trial team to any changes in 
the participants’ status such as:  
 
- New medical diagnosis or co-morbidity  
- Start of new medication and removal of a medication  
- Admission to hospital or visit to A&E or GP  
- New investigations that have been arranged  
- New onset of symptoms or worsening of previous symptoms  
- Change in known co-morbidities  
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1. Safety Escalation Process 
 
 
Low Risk
• Defined as a scenario where telephone advice is required
• Ring Frail2Fit team on (insert number here)
Intermediate 
Risk
• Defined as a scenario where the volunteer is unsure whether 
proceeding with the session is safe or requires further advice opost 
session. These scenarios may or may not require further action.
• Ring Frail2Fit team on (insert number here)
Emergency 
Scenario
• This is defined as anything the volunteer feels is an emergency
• Ring 999 or refer participant to 999 / 111 if able
• When appropriate please alert the Frail2Fit team on (insert number 
here)