Feasibility, Usability, Acceptability and Efficacy of a Novel Leg Strengthening Device (S-Press) for Strengthening Leg Muscles and Improving Physical Impairment During Hospital Admission
Phase: NA
Conditions: Deconditioning, Sarcopenia
Sponsor: Sheffield Hallam University

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 1 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
 
 
    
S-Press research project proposal 
(clean version) 
 
Full title of investigation: 
 
Efficacy, feasibility, usability, and acceptability 
of the S-Press leg strengthening device for 
strengthening leg muscles and improving 
physical impairment of older adults. 
Short title: 
S-Press evaluation 
 
Version of research project proposal 
 
Version 11.2 NHS. - clean version    01/12/2020 
Sponsor: 
JT Rehab Ltd 
 
Sponsor CIP number: 
JT Rehab-01 
 
Funder: 
Versus Arthritis 
 
 
 
 
 
 
 
 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 2 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
 
INDEX 
 
PAGE 
NUMBER 
INFORMATION 
PAGE  4-5 
Sponsor of study 
Principle investigators – site 1 and site 2 
Chief Investigators 
Investigation sites 
PAGE 6 
Summary of the study proposed 
PAGE 6-8 
Background and scientific justification 
PAGE 8 
Description of intended purpose and mode of action of device: 
Research aims 
PAGE 9 
Research objectives 
Type of study design 
PAGE 9-11 
Purpose of study 
Study classification 
Same size – justification 
Number of centres – justification 
Duration of study – justification 
PAGE 12 
Criteria for participant selection 
PAGE 13-14 
Criteria for participant withdrawal 
Description of the generally recognised medical diagnosis for which investigational 
testing is being proposed 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 3 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Proposed post-market clinical follow-up plan 
PAGE 14-16 
Physiological assessments – Quantitative data 
PAGE 17-18 
Data collection for qualitative study aspects 
PAGE 18-19 
Serious adverse event reporting 
PAGE 20-22 
References 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 4 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Sponsor of study 
Sponsor – JT Rehab Ltd 
 
Sponsors representative  
Mrs Jennifer-Jane Turner 
JT Rehab Ltd 
10 Everard Avenue 
Sheffield 
S17 4LZ 
 
Principle Investigator - Sites 1, 2 and 3 
Dr Bharath Lakkappa – Trust Clinical Director 
Northamptonshire Healthcare NHS Foundation 
Trust  
Bevan House Kettering Parkway, Kettering 
NN15 6XR 
 
Principle Investigator – Site 4 
Dr Paul Koranteng 
 
Berrywood Hospital 
Berrywood Dr, Duston, Upton, Northampton 
NN5 6UD 
 
Chief Investigator – Quantitative research 
Dr Tom Maden-Wilkinson 
 
Sheffield Hallam University 
Advanced Wellbeing and Research Centre 
Olympic Legacy Park 
Leeds Road 
Sheffield 
S9 3TY 
Chief Investigator – Qualitative research 
Dr Kate Walker 
Research Associate 
 
Northamptonshire Healthcare NHS Foundation 
Trust 
Innovation and Research Department 
Berrywood Hospital 
Northampton 
NN5 6UD 
 
NHS Site 1 
 
Danetre Hospital 
Northamptonshire Healthcare NHS Foundation 
Trust  
Daventry NN11 4EB 
NHS Site 2 
 
 
Isebrook Hospital 
Northamptonshire Healthcare NHS Foundation 
Trust  
Irthlingborough Rd N, Wellingborough NN8 1LP 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 5 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
NHS Site 3 
 
 
Corby Hospital 
Northamptonshire Healthcare NHS Foundation 
Trust  
Cottingham Rd, Corby NN17 2UN 
 
NHS Site 4 
 
 
Berrywood Hospital 
Berrywood Dr, Duston, Upton, Northampton 
NN5 6UD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 6 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
 
Summary of the study proposed: 
The proposed study will examine the use and effectiveness of a novel strength training device – The 
S-Press within an NHS environment. The S-Press is a portable exercise device that can be used 
seated or lying down and specifically targets the knee extensors and flexors. The knee extensors are 
particularly important in the performance of activities of daily living such as rising from a chair, 
walking up and down stairs and walking.  
Resistance training is the most effective strategy to help to reduce muscle wasting in response to 
ageing or chronic disuse; however as current in-patient settings likely fail to produce an overload 
stimulus to the muscle for hypertrophy and strength gains, there is a need to develop new 
interventions and equipment to help deliver this. The S-Press is designed by a Physiotherapist with 
the goal of increasing muscle strength and improving physical function in patients who may be 
confined to their bed or chair or unable to join in with standard physiotherapy treatments.   
This mixed methods study will examine the efficacy of the S-Press to improve muscle size using B-
Mode Ultrasound and physical function, using sit to stand x5 with use over 6 weeks, alongside the 
qualitative experience of the use of the S-Press through a one to one semi structured interview. Data 
collected will enable CE marking of the device along with the existing data collected and enable 
onward NHS studies. 
This novel device should improve outcomes for users, with the eventual aim of easing pressure on 
NHS staff and produce NHS cost savings by helping prevent delays in discharge which cost the NHS 
£820 million each year. 
 
Background and scientific justification:  
Prevention of hospital associated deconditioning is an immediate healthcare unmet need. 10.5 
million vulnerable older adults are admitted into UK hospitals annually.  Muscle deconditioning 
begins within 2 days, with baseline strength reducing by up to 20% in 1 week and 68% of patients 
discharged below their pre-admission level of function (Kortebein et al., 2008; Falvey et al., 2015). 
These patients are 3x more likely to be re-admitted within 30 days and de-conditioning is 
responsible for 47% of delayed discharges (Lim et al., 2006). 
Preserving muscle strength and function has many contributing factors; with physiotherapy having a 
key role. Progressive resistance exercise (PRE) is known to increase muscle strength in even the 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 7 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
frailest individuals (Suetta et al., 2007) and researchers suggest that PRE should be used more in 
hospitals to prevent deconditioning and improve outcomes (Falvey et al., 2015). There is limited PRE 
equipment available for physiotherapists, its use compounded by a lack of clinical time and staff. The 
new S-Press portable leg strengthening device has been designed by a physiotherapist to improve 
access to effective PRE for vulnerable older patients and ease workload for physiotherapists. 
PRE benefits have been well documented since the 1950s, yet physiotherapists working in hospitals 
rarely use it with patients.  There are many reasons for this including health barriers, institutional 
barriers, changing demand on physios within the NHS and lack of appropriate equipment for 
effective use. Guthrie Smith (1943) invented the revolutionary sling/spring suspension format used 
for decades by physiotherapists. The S-Press utilises this tried and tested principle in a re-imagined 
/re-designed mechanical gym-equipment style, for portability, accessibility and use by vulnerable 
temporarily immobile patients in need of muscle strengthening if confined to their bed or chair.  
Leg muscle weakness, especially knee-extensor strength, is associated with increased falls risk 
(Tinetti 1988; Wolfson 1995) and decrease in function (Van Roie et al., 2011).  Leg strength gain is 
associated with improvements in sit to stand, gait, transfers, stair climbing and confidence (Chandler 
1998). A study is needed to assess if providing PRE to older adults via use of the S-Press device has a 
beneficial effect on muscle strength and if this translates into functional task improvement.  
PPI using expert patients and clinicians from three NHS Trusts have participated in focus groups. A 
national proof of market study run by NIHR Devices for Dignity has shown a positive response to the 
S-Press concept and recognition of its potential value.  These discussions have all contributed to the 
final S-Press design decisions and features. In-patient feedback on physiotherapy interventions 
describes a feeling of achievement and a sense of doing 'real physio' when using exercise devices, as 
compared to ‘just walking’.  Competition between patients is also known to be beneficial and 
encourages participation and improvement; all achievable with S-Press use. 
Success criteria will be to show clinically significant improvements in lower limb muscle size, sit to 
stand ability of 15 - 20 older adults, and the views on use and acceptability with users and staff, 
following   6   weeks of training with the S-Press. Evidence that this improvement in lower limb 
muscle size and strength transfers to an improvement in a range of selected validated functional 
skills and sufficient user qualitative feedback will allow CE marking of the device enabling further 
NHS studies. 
The project lead and S-Press inventor is a physiotherapist with 22 years of older people’s 
rehabilitation experience.  Researchers from Sheffield Hallam University will devise, run, and analyse 
the quantitative data from the study. The qualitative element of the real-world evaluation will be 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 8 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
performed and analysed by the research team at Northamptonshire Healthcare NHS Trust. Devices 
for Dignity have previously provided proof of market evidence and will provide regulations 
assistance, health economics and commercialisation to enable CE marking. S-Press development has 
been funded by Versus Arthritis.   
To gain CE mark as a class 1 medical device a clinical evaluation needs to be performed with older 
people. NHS patients will be perfect participants to trial this fully safety tested exercise device.   
Description of intended purpose and mode of action of device: 
The S-Press is a mechanical single leg strengthening device, using spring resistance to provide a 
progressive increase in resistance level from 3kg to 20kg resistance level.  The S-Press requires 
physical effort from the user to work, through a push or pull action of the leg whilst the leg is 
positioned on a supportive leg rest.  The S-Press can be used on the bed or positioned on the floor if 
user is sitting in a chair.  The intended purpose of the S-Press is to strengthen the quadriceps and 
hamstring muscles and provide improvement in the physical ability of the user, such as sit to stand, 
transfer and walking ability. 
Research aims: 
To assess the efficacy, feasibility, usability, and acceptability of use of the S-Press by NHS staff using 
it with an older NHS in-patient population, for strengthening quadriceps and hamstring muscles and 
improving physical impairment. 
Research objectives: 
Primary Objectives: 
The primary objectives are to quantify changes in the following in response to 12 sessions (2x per 
week for 6 weeks) of using the S-Press device supervised by a Physiotherapist. The primary 
outcomes are to assess: 
• Functional improvements using the 5x sit to stand test.  
• Morphological changes, measuring muscle thickness of the Vastus Lateralis and Rectus 
Femoris muscle using B-Mode ultrasound. 
• Any safety issues with S-Press use with older users. 
• Perceptions of usability of the S-Press with older adult users and care givers. 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 9 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Secondary Objective: 
• 
To meet CE marking requirement 
• 
To enable further follow-on evaluation in different NHS environments 
• 
Commercialisation. 
Type of study design: 
This is a single-arm, mixed methods study design.  Quantitative and Qualitative research methods 
planned.   
Purpose of the study: 
To gain user data for feasibility of use and acceptability in the NHS environment and safety and 
efficacy to enable CE marking for further follow-on NHS studies. 
Study classification: 
Efficacy and feasibility study. 
Sample size justification: 
For the study we will aim to recruit 15 – 20 NHS in-patient participants across the 4 sites.  Sample 
size aligns with previous research studies using similar methodology (e.g., Dibble et al. 2006; Alkner, 
et al., 2004; Frontera, et al., 1988; Fiatarone, et al., 1990;  Grimby, et al., 1985; Pyka, et al. 1994; 
Hagerman et al. 2000; Hepple, et al. 1997) 
Typical exercise training studies of this length have 10-15 participants per arm of the trial. This 
would conventionally include a control group. As this is a feasibility trial, the advice from our RDS 
was that a control group was not required. An N of 12 has been recommended as a minimum 
number of participants per group to be recruited for a clinical trial where there is no prior 
information to guide sample size (Julious 2005). This figure is suggested to represent the lower 
threshold required to estimate the standard deviation of measures with adequate precision. We aim 
to recruit 15 – 20 participants to the study to allow for a predicted 20% attrition rate.  
This low number of patient participants per site will provide a low burden for the staff participants. 
 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 10 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Number of centres justification: 
Four NHS sites have requested to participate, this will ensure enough participants are able to be 
recruited who are able to provide informed written consent to be included and maintain a low 
burden for the participating ward staff. 
Justification for NHS staff involvement and numbers: 
The role of the NHS physio team is to enable the fastest recovery of sit to stand and transfer ability 
to enable speedy discharge of in-patient’s home to a familiar environment. Strengthening exercise 
provision is a standard treatment provided for this purpose, limited in many Trusts by availability of 
appropriate equipment. Provision of several free exercise devices per site that can deliver effective, 
specific, sit to stand muscle strengthening for the length of the trial, is a good benefit to the staff and 
the patients.   The number of patient participants is being kept at a low level of 4 patients per site.  
Senior management have buy-in from the staff and have appropriate safe staffing levels available to 
participate in the study. Number of exercise sessions will be twice a week to follow national 
recommendations for strength training, for approximately 30 minutes.  Patients are seen daily on 
the ward for therapy intervention including strengthening and mobility work. Daily, 30-minute 
sessions are the gold standard for daily therapy interventions. 
No specific number of staff participants has been set to be recruited, so there is no added pressure 
for participation. There will be 2 devices per site available so a minimum of 2 staff members per site 
is preferred for the study to maximise the benefit and use of the S-Press and for feedback. 
Duration of study – justification 
The time course of adaptations in muscle strength, mass and function is complex. During the first 
weeks of strength training, the brain responds to training by recruiting more motor units with each 
muscle contraction. This increases the force you can generate.  It also increases how rapidly these 
motor units fire, this is called neuromuscular adaptation. After 4 to 6 weeks of training, if the 
muscles have been challenged sufficiently, the muscle fibres will start to increase in size, this causes 
a greater increase in muscle strength as the muscle cross-sectional area enlarges or “hypertrophies”. 
Previous research studies (Dibble et al. 2006; Alkner, et al., 2004; Frontera, et al., 1988; Fiatarone, et 
al., 1990;  Grimby, et al., 1985)  using resistance exercise show a varied duration.  Most commonly 
studies of between 10 – 12 weeks are performed.  The S-Press research study will perform resistance 
exercises for a 6 -week period. This is the amount of time that the patients are in-patients on the 
ward and gives enough time to observe changes in strength and muscle fibres over this time. 
The study will be completed by June 2022. 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 11 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Criteria for participant selection:  
1 - NHS in-patients – quantitative and qualitative arms of the study 
Inclusion criteria: 
• 
Any in-patient admitted onto the ward sites for therapy intervention, assessed as medically 
stable and physically able to participate by nursing staff and able to provide informed 
written consent for participation.   
The implications of joining the study will be discussed with the participant to ensure full 
understanding. Written documentation with explanation of study will be left with participant for 
relatives/carers information. 
Exclusion criteria:  
• 
Any patient who is unable to give informed consent. 
• 
Significantly confused patients - may not understand or retain the information to perform 
the exercises so will be excluded from this study. 
• 
Patients with unstable or deteriorating medical conditions or are acutely unwell with an 
infection. 
• 
Patients unable to do leg press exercise 
• 
Patients who have had major surgery or myocardial infarction within the past 6 months.  
• 
Patients who have major surgery scheduled during the intervention period. 
• 
Patients currently undergoing treatment for cancer 
• 
Patients who currently have high blood pressure that is uncontrolled (Systolic >200mmHg or 
Diastolic > 110mmHg) 
• 
Patients with a physical disability that precludes safe and adequate testing. 
• 
Patients with acute pulmonary embolism, infarction, or deep venous thrombosis. 
 
 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 12 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
2 - NHS Staff – Qualitative arm of the study only 
Inclusion criteria: 
• 
Any NHS staff delivering therapy care to in-patients (for example: qualified physiotherapists, 
physiotherapy assistants or technical instructors, trained nurses, clinical support assistants, 
and activity co-ordinators).   
Staff will be trained to set up and deliver the S-Press exercise session with the patients.  This should 
constitute minimal additional work burden as they would be exercising with these patients during 
their normal 30-minute physio session and will give alternative therapeutic options for treatment 
sessions. 
Exclusion criteria: 
• 
Any staff who do not deliver therapy care (for example catering and domestic staff).  
Criteria for participant withdrawal 
Participants (both NHS staff and in-patients) may voluntarily withdraw from the study at any point. 
Participants will be informed that their participation is voluntary and that they may withdraw from 
the study at any time without giving a reason and without it affecting their clinical care or legal 
rights. Any data provided to that point will be used unless the patient requests otherwise. If the 
patient requests to have their data withdrawn, all data relating to that participant will be securely 
destroyed. From a clinical perspective, any in-patient participant that experiences an adverse event 
will be removed from the study. During exercise sessions, heart rate and blood pressure will be 
monitored, and where necessary sessions ceased. For blood pressure measures, exercise sessions 
will be stopped a systolic blood pressure measurement of >210mmHg for men and >190mmHg for 
women or a decrease of systolic blood pressure >10mmHg from resting values will be considered as 
stop points (American College of Sports Medicine, Guidelines for exercise testing and prescription, 
10th Edition).  The occurrence of such event will be classed as criteria for withdrawal from the study 
on safety grounds. 
There is a very small chance of joint injury around the knee or an increase in pain associated with 
osteoarthritic joints. Knee injury risk will be reduced by the supervision of sessions and 
individualised set up of the S-Press device. A significant increase in joint pain resulting from using the 
device will be a withdrawal criterion. 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 13 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Should participant withdrawal occur, this will be followed-up by the chief investigator and 
documented with the study findings. 
Description of the generally recognised medical diagnosis for investigational testing 
The generally recognised medical diagnosis of muscle weakening due to the de-conditioning effect, 
post injury or illness, and sarcopenia and natural age-related muscle weakening is being proposed 
for the study. 
Proposed post-market clinical follow-up plan: 
There is no specific post-market follow-up set up yet due to this being a preliminary efficacy and 
feasibility study.   
On-going evaluation of products on the market will be performed through planned customer 
feedback and customer services.  Only through constant systematic market surveillance (post-
market surveillance) can JT Rehab guarantee that the S-Press provides the promised benefit to 
patients as well as the lack of any unrestrained risks. 
 If "regular market surveillance" does not provide sufficient data, post-market clinical follow-up 
studies regarding the manufacturer may become necessary. 
To meet MDR requirements, JT Rehab will design and run PMCF studies with three major goals in 
mind: 
• 
Confirming device safety and clinical performance 
• 
Ensuring continued acceptability of identified risks 
• 
Detecting emerging risks based on factual evidence 
Physiological Assessments (Quantitative Data) 
These assessments will be conducted at baseline (start) and at the end of the intervention period (6 
weeks). Post testing will be conducted 48-72 hours post final exercise session to allow for any fluid 
changes within the muscle to subside and minimise fatigue of participants. There will be a 
familiarisation session for all participants prior to completing the baseline assessments to minimise 
any learning effects of the assessments.  
 
 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 14 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Familiarisation 
Following obtaining informed consent, participants will be provided with an opportunity to have a 
practice attempt/s at each of the assessments and also the exercise session. For the exercise 
sessions this will be used to identify the starting point in terms of resistance for each individual. All 
exercise sessions and assessments will be performed on the ward minimising extraneous travel costs 
for participants.  
The physiological assessments are as follows: 
Muscle thickness  
The muscle thickness of the Vastus Lateralis and Rectus Femoris of each leg will be determined by B-
Mode Ultrasonography (Healcerion, UK), this will be conducted by a qualified member of the 
research team with the appropriate skills and training. The measurements will be conducted at 50% 
of femur length, determined by the distance between knee joint space and greater trochanter as 
defined by palpation. Muscle thickness will be quantified using ImageJ (NIH, USA) post-hoc. Images 
will be saved on the Healcerion system as anonymised codes, i.e. SPRESS-1-Pre. Images will then be 
anonymised and coded by another member of the team before being analysed blindly by Dr Tom 
Maden-Wilkinson (Co-I), using ImageJ Software (NIH,USA) 
5 x sit to stand 
In-patient participants will be timed for how long it takes them to complete 5x sit to stand. 
Participants will be allowed to use their ambulatory aides if required and this noted. Participants will 
have an investigator near them to prevent an adverse falls or loss of balance. Where this takes 
longer than 60s, the number of complete movements and the time it took for those will be recorded. 
Participants will be asked to complete this 3x if possible, with sufficient rest in between each 
attempt, to enable an average to be taken. 
Exercise Sessions 
First, participants will be asked to warm up supervised by the physiotherapist, this will incorporate 
some low intensity range of movement exercise and light stretching. 
Staff participants will set up the patient participant using the S-Press protocol for set up.  Patients 
can remain on the bed or in the chair so will not require transferring or position change by the staff 
for use. 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 15 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
Initial assessment of appropriate resistance level will be examined at the beginning of the first 
session, by assessing the patient participants 1 repetition max (1RM) level (maximum resistance 
level ability - Instructions stated in set up protocol). 
Participants will then complete 3 sets of 10 repetitions on each leg firstly for the knee extensors and 
then the knee flexors. The S-Press allows both Concentric and Eccentric muscle actions, so muscle 
groups are performed independently. A guide of 1 minute’s rest will be provided in between sets 
and legs, although more rest will be allowed if required by the participants. The amount of time per 
exercise session will be approximately 30 minutes.  
Blood pressure and heart rate will be measured before the exercise session begins, mi-way through 
and again at the end of the session.  This is to ensure that there is maintenance of optimal levels of 
blood pressure and heart rate and monitoring of any adverse effects. These measurements are 
regularly taken by therapy staff to assess their patients’ conditions before and during physical 
intervention. 
Data from the assessments will be analysed using paired t-tests. As this trial is an efficacy and 
feasibility trial descriptive statistics (mean, standard deviation and % Change) will be calculated. In 
addition, Cohen’s D will be used to determine effect sizes to quantify the magnitude of any 
differences in variables. A p value of p<0.05 will be used to determine significance, with effect size of 
<0.2=small; 0.5= moderate; >0.8 large.  
Data collection – for Qualitative study aspects 
The 15-20 NHS in-patient participants who have participated in the 6-week exercise trial will be 
invited to consent to a one-to-one semi-structured interview by telephone or online if able (due to 
Covid-19 restrictions), to explore their experience of the usability and acceptability of the device. 
The clinician/PI will provide patient with PIS and consent statement for them to read. If a patient 
agrees to participate, the interview will be scheduled no sooner than 48 hours afterwards, to ensure 
time for consideration 
On the interview date, the participant will be invited to provide informed verbal consent. This 
consent will be recorded on a separate recorded file, which will be stored on a secure NHS server. 
Any participants whom the NHS staff identify as requiring communication support to understand 
and/or answer questions will be offered the option of nominating a friend or relative to support 
them in the answering the interview questions. 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 16 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
NHS staff who have observed at least one treatment session will also be invited to participate in a 
semi-structured one to one interview by telephone or online (due to Covid-19 restrictions) to 
explore their perspective on usability and feasibility of the device within the setting they work in.  No 
set sample size target is set for this group to ensure staff do not feel under any obligation to take 
part.  The Ward Managers have considered their staffing levels and consented to participation of 
eligible staff where informed consent is given.   
Objectives: 
To explore feasibility, usability, and acceptability of the device with: 
• 
NHS staff who have supported the 15-20 in-patient participants who have used the device 
• 
15-20 in-patients who have used the device 
Semi-structured interviews will be undertaken with both the staff and patients, on a one-to-one 
basis. The interviews will be recorded and transcribed verbatim. 
Analysis: 
Qualitative Thematic Analysis will be undertaken, as informed by Braun and Clarke (2006) involving a 
6-step framework analysis approach. Interviews will be coded using a prori topical codes according 
to the three assessment areas of interest, feasibility, usability, and acceptability. NVivo will be used 
to organise and analyse the data. The 6-steps followed will be: 
1) Familiarisation with the data: Data will be transcribed, read, and re-read, and initial codes 
noted. Any missing or ambiguous data will be resolved at this stage. 
2) Generating initial codes: Interesting features across the data set will be coded, and data 
relevant to each code collated. 
3) Searching for themes: Codes will be collated into potential themes, and the data relevant to 
them gathered. A theme index of the themes and subthemes will be created. 
4) Reviewing themes: Themes will be assessed, combined, refined, separated, and discarded 
accordingly. A framework will be developed which comprises a matrix for each theme. 
5) Defining and naming themes: Operationalisation of each theme and subtheme and a clear 
working definition that capture the essence of each theme will be developed. 

             
                       
        
 JT REHAB LTD 
Short title: S-Press   
Sponsor code: JT Rehab-01 
IRAS number: 251647 
 
Page 17 of 20 
Research proposal    Version 11.2 NHS  01/12/2020 – clean version 
6) Producing the report: The overall learning from the qualitative data analysis will be 
presented in a report summarising the themes and illustrating these with noteworthy 
(anonymised) quotes and tables of descriptive quantitative data. 
This process will be completed with attention to the guidance on principles of Credibility, 
Transferability, Dependability and Confirmability (Cochrane Collaboration Qualitative Methods 
Group, 2011), and following guidelines by Shenton (2004). 
Serious adverse event reporting: 
Potential adverse events that are common to novel physical activity such as delayed muscle 
soreness, feeling faint as well as temporary increases in heart rate, breathing rate and blood 
pressures, are planned for within the study and risk minimized with a thorough warm up and cool 
down with participants as well as supervision throughout the session. 
There is a very small chance of joint injury around the knee or an increase in pain associated with 
osteoarthritic joints. Knee injury risk will be reduced by the supervision of sessions and 
individualised set up of the S-Press device. A significant increase in joint pain resulting from using the 
device will be a withdrawal criterion. 
Although there is a risk associated with physical activity, numerous studies have shown that physical 
activity is safe, and beneficial to the health of patients in this environment (Henskens et al., 2018; 
Kalinowski et al., 2012). The most severe risks associated with physical activity are death or serious 
cardiac event (Vuori 1986).  
Increasing or maintaining skeletal muscle mass has also been shown to increase quality of life and 
reduce the incidence of MSK injuries caused by trips and falls (Skelton & Beyer 2003).  
Participants will be made aware of all the processes involved in data collection stages before the 
beginning of the study. Individual clinicians will be aware of their medical history and will have up-
to-date training on first aid and dealing with any adverse events that could potentially occur. 
Individual sessions will be postponed or cancelled if an individual is feeling unwell. If the session has 
started and participants suddenly feel ill whilst performing exercises or they experience tissue 
viability issues to do with skin integrity or damage caused by the S-Press or signs of cardiac event, 
then nursing staff will be alerted and session ended. Any adverse event, serious or not will be 
reported back to nursing staff and reported with the daily log and data collection sheets. 
Data will be collected in line with the NIHR guidance on good clinical practice. The PI will ensure the 
study is carried out in accordance with the protocol (equipment calibrated, facilities suitable and 

             
                       
        
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health and safety measures in place). All correspondence with participants will be recorded in the 
site file, and any adverse findings, procedural errors or amendments to the protocol will be 
explained in detail to participants as soon as possible. All deviations will be reported to the MHRA. 
 
 
 
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resistance training amplifies muscle hypertrophy and functional gains in persons with 
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IRAS number: 251647 
 
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Grimby, G., Aniansson, A., Hedberg, M., Henning, G.B., Grangård, U., & Kvist, H. (1992). Training can 
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Effects of High-Intensity Resistance Training on Untrained Older Men. Journal of 
Gerontology, 55A(7), B336-B346 
Hepple, R.T., Mackinnon, S.L., Goodman, J.M., Thomas, S.G., & Plyley, M.J. (1997). Resistance and 
aerobic training in older men: effects on VO2peak and the capillary supply to skeletal 
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Kortebein, P., Brock Symons, T., Ferrando, A., Paddon-Jones, D.,  Ronsen, O., Protas, E.,  Conger, S., 
Lombeida, J., Wolfe, R., & Evans, W.J.  (2008). Functional impact of 10 days of bed rest in 
healthy older adults. Journal of Gerontology: Biological Sciences, 63(10), 1076-81. 
Lim, S.C., Doshi, V., Castasus, B., Lim, J.K., & Mamun, K. (2006). Factors causing delay in discharge of 
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Pyka, G., Lindenberger, E., Charette, S., Marcus, & R.  J Gerontol. (1994). Muscle strength and fiber 
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Tinetti, M.E., Speechley, M., & Ginter, S.F. (1988). Risk factors for falls among elderly persons living 
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Van Roie, E.,  Verschueren, S.M., Boonen, S., Bogaerts, A., Kennis, E., Coudyzer, W., & Delecluse, C. 
(2011). Force velocity characteristics of the knee extensors: An indication of the risks of 

             
                       
        
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IRAS number: 251647 
 
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physical frailty in elderly women. Archives of physical medicine and rehabilitation, 92(11), 
827-1832.  
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