Can a Brief Behavioural Assessment Improve Exercise Adherence in Older People With Musculoskeletal Conditions: A Feasibility Randomised Controlled Trial
Phase: NA
Conditions: Geriatric, Exercise Adherence
Sponsor: Oxford University Hospitals NHS Trust

                       
 
                                                      
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Study Title:  
Can a brief behavioural assessment improve exercise adherence in older 
people with musculoskeletal conditions? A feasibility randomised 
controlled trial   
Short Title  
Adherence for Exercise Rehabilitation in Older people (AERO) trial  
Ethics Ref: 18/SC/0416 
Date and Version No: 28th June 2018 Version 1.0 
Chief Investigator: 
Jonathan Room  
Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford 
University Hospitals NHS FT  
Tel: 01865 737526 
Email: jonathan.room@ouh.nhs.uk   
Investigators:  
Professor Karen Barker  
Director of Orthopaedics, Nuffield Orthopaedic Centre, Professor of 
Physiotherapy NDORMS  
Professor Helen Dawes  
Director Centre for Movement, Occupation and Rehabilitation Sciences 
(MOReS), Oxford Brookes University 
Professor Mary Boulton  
Professor of Health Sociology, Oxford Brookes University  
Sponsor:  
Oxford University Hospitals NHS Foundation Trust  
Funder: 
Physiotherapy Research Unit, Nuffield Orthopaedic Centre  
Chief Investigator Signature:  
 
Jonathan Room                            Date 28thJune 2018  
The investigators declare no conflicts of interest to declare 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, HRA, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so.

                       
 
                                                      
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TABLE OF CONTENTS 
 
1. 
SYNOPSIS .............................................................................................................................................. 4 
2. 
ABBREVIATIONS ................................................................................................................................... 4 
3. 
BACKGROUND AND RATIONALE ........................................................................................................... 5 
4. 
OBJECTIVES AND OUTCOME MEASURES .............................................................................................. 6 
5. 
STUDY DESIGN ...................................................................................................................................... 7 
6. 
PARTICIPANT IDENTIFICATION ............................................................................................................. 7 
6.1. 
Study Participants ......................................................................................................................... 7 
6.2. 
Inclusion Criteria ........................................................................................................................... 7 
6.3. 
Exclusion Criteria .......................................................................................................................... 7 
7. 
STUDY PROCEDURES ............................................................................................................................ 7 
7.1. 
Recruitment .................................................................................................................................. 8 
7.2. 
Screening and Eligibility Assessment ............................................................................................ 8 
7.3. 
Informed Consent ......................................................................................................................... 8 
7.4. 
Randomisation, blinding and code-breaking ................................................................................ 9 
7.5. 
Baseline Assessments ................................................................................................................... 9 
7.6. 
Subsequent Visits ....................................................................................................................... 10 
7.7. 
Discontinuation/Withdrawal of Participants from Study............................................................ 11 
7.8. 
Definition of End of Study ........................................................................................................... 11 
8. 
INTERVENTIONS ................................................................................................................................. 11 
9. 
SAFETY REPORTING ............................................................................................................................ 13 
9.1. 
Definition of Serious Adverse Events .......................................................................................... 13 
9.2. 
Reporting Procedures for Serious Adverse Events ..................................................................... 14 
10. 
STATISTICS AND ANALYSIS .............................................................................................................. 14 
10.1. 
Sample size ............................................................................................................................. 14 
10.2. 
Analysis plan ........................................................................................................................... 14 
10.3. 
Analysis of Outcome Measures .............................................................................................. 14 
11. 
DATA MANAGEMENT ..................................................................................................................... 15 
11.1. 
Access to Data ........................................................................................................................ 15 
11.2. 
Data Recording and Record Keeping ...................................................................................... 15 
12. 
QUALITY ASSURANCE PROCEDURES ............................................................................................... 16 
13. 
ETHICAL AND REGULATORY CONSIDERATIONS .............................................................................. 16 

                       
 
                                                      
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13.1. 
Declaration of Helsinki ............................................................................................................ 16 
13.2. 
Guidelines for Good Clinical Practice ...................................................................................... 16 
13.3. 
Approvals ................................................................................................................................ 16 
13.4. 
Reporting ................................................................................................................................ 16 
13.5. 
Participant Confidentiality ...................................................................................................... 16 
13.6. 
Expenses and Benefits ............................................................................................................ 17 
13.7. 
Other Ethical Considerations .................................................................................................. 17 
14. 
FINANCE AND INSURANCE.............................................................................................................. 17 
14.1. 
Funding ................................................................................................................................... 17 
14.2. 
Insurance ................................................................................................................................ 17 
15. 
PUBLICATION POLICY...................................................................................................................... 17 
16. 
REFERENCES ................................................................................................................................... 18 
17. 
APPENDIX A:  AMENDMENT HISTORY ............................................................................................ 21 

                       
 
                                                      
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1. SYNOPSIS 
Study Title 
Can a brief behavioural assessment improve exercise adherence in older 
people with musculoskeletal conditions? A feasibility randomised controlled 
trial   
Internal ref. no. / short 
title 
Adherence for Exercise Rehabilitation in Older people  (AERO) trial 
Study Design 
Feasibility Randomised Controlled Trial  
Study Participants 
People over 65 years of age with a musculoskeletal condition  
Planned Sample Size 
40-50  
Planned Study Period 
1 year  
 
Objectives 
Outcome Measures 
Primary 
 
To assess the feasibility of the study 
design to determine if a large scale 
RCT is possible. 
Recruitment numbers, dropout 
rate, fidelity and acceptability  
Secondary 
 
To assess participants exercise 
adherence, and behavioural 
regulation regarding exercise 
 
 
• 
Self-reported adherence Scale 
and exercise diary  
• 
Tilburg Fraility Indicator (TFI)  
• 
Physical Activity Scale for the 
Elderly (PASE) 
• 
EQ 5D 5L  
• 
Self-Efficacy for Exercise Scale  
• 
Exercise regulation 
Questionnaire (BREQ-3) 
• 
Global rating of change (GROC) 
• 
VAS score, self-rated capacity 
to exercise, confidence to 
exercise and motivation to 
exercise 
Tertiary  
Acceptability of the intervention 
Qualitative interviews 
 
2. ABBREVIATIONS 
 
CI 
Chief Investigator 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
HRA 
Health Research Authority 

                       
 
                                                      
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ICF 
Informed Consent Form 
NHS 
National Health Service 
NRES 
National Research Ethics Service 
PASE 
Physical Activity Scale for the Elderly 
PI 
Principal Investigator 
PIL 
Participant/ Patient Information Leaflet 
R&D 
NHS Trust R&D Department 
RCT  
Randomised Controlled Trial  
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 
TFI  
Tilburg Frailty Indicator 
 
3. BACKGROUND AND RATIONALE 
Prescribed exercise is a common treatment modality used by physiotherapists(1); surveys of practice 
confirm its use across a range of conditions(2–6) . Exercise has been documented as an effective 
treatment option for numerous conditions, including musculoskeletal complaints such as knee and hip 
osteoarthritis (7,8), back Pain (9,10), neck pain (11,12), work-related arm, neck or shoulder 
complaints(13), rotator cuff impingement (14), subacromial  impingement syndrome (15), ankle 
sprains(16), hamstring injuries (17), and falls prevention(10). This is in addition to its use in conditions 
such as diabetes (18), heart disease (10,19), chronic obstructive pulmonary disease (COPD) (10) and 
chronic fatigue syndrome (10). In a number of chronic conditions its effectiveness may be comparable to 
drug interventions (20).   
In a seminal paper on exercise adherence Slujis et al (21) found that 22% of patients were non-adherent 
with 41% being partially adherent. Similar figures have been demonstrated subsequently (22). Exercise 
adherence can affect treatment outcomes, such as pain, physical function and physical performance 
(23,24). Given that adherence may limit the effectiveness of prescribed exercise, it is an important 
consideration for those who prescribe exercise.    
Adherence to prescribed exercise is an importance consideration for older people. Exercise adherence in 
the older population is affected by health status (25), and it is known that older people are more likely to 
have long term conditions or multiple long term conditions (26), for which prescribed exercise is a 
treatment option (10). Engagement in exercise is known to be poor in the older population following 
discharge from hospital (27), or discharge from physiotherapy (28). This is an important consideration, as 
treatment outcomes in older people are linked to compliance with interventions (29). A number of 
different factors have been reported to affect exercise adherence in older people, these include low self-
efficacy, low motivation, depression, lack of interest, fear of falling, health status, physical ability, low 
expectations, socioeconomic status and exercise programme characteristics (25,27,28). It is of 

                       
 
                                                      
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importance to understand the role of personal factors and programme characteristics. However, it is also 
critical to establish if there is anything the clinician can do to enhance exercise adherence in older 
people.  
The aim of exercise adherence interventions is to increase the likelihood that people will follow 
prescribed exercise, in this way they fulfil the definition by NICE (30) of a behaviour change intervention, 
‘…sets of techniques, used together, which aim to change the health behaviours of individuals, 
communities or whole populations’. Many previous behavioural interventions have been designed 
utilizing what Martin Eccles calls the ISLAGIATT principle, ‘it seemed like a good idea at the time’ (31). A 
recent systematic review of exercise adherence interventions for older populations concluded that there 
was a need for the development of theoretically derived interventions in the area of exercise adherence 
for older people (32).This lack of theoretical underpinning could potentially limit the effectiveness of 
interventions. Therefore this project will review exercise adherence in older people piloting a brief 
behavioural assessment and targeted adherence approaches against usual care.   
4. OBJECTIVES AND OUTCOME MEASURES 
 
Objectives 
Outcome Measures  
Time points 
Primary Objective 
To determine if a large scale RCT is 
feasible   
Recruitment 
numbers, 
dropout 
rate, 
fidelity and acceptability 
End of study  
Secondary Objectives 
To assess participants exercise 
adherence, and behavioural 
regulation regarding exercise  
 
 
Self-reported adherence Scale and exercise 
diary  
Questionnaires –  
Tilburg Fraility Indicator (TFI)  
Physical Activity Scale for the Elderly 
(PASE) 
EQ 5D 5L  
Self-Efficacy for Exercise Scale  
Exercise regulation Questionnaire (BREQ-3) 
Global rating of change (GROC) 
VAS – self rated score of capacity to 
exercise, confidence to exercise and 
motivation to exercise 
6 week follow up 
and 12 week follow  
up  

                       
 
                                                      
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Tertiary Objectives 
To determine if the intervention is 
acceptable to participants  
Qualitative interviews with sub-sample of 
participants  
Post 
12 
week 
follow up prior to 
end of study  
 
5. STUDY DESIGN 
This study will be a two arm feasibility randomised controlled trial. Participants will be randomised 
between usual care or the intervention arm which will consist of a brief behavioural assessment and 
recommended adherence strategies based on the outcome of the assessment. A sub sample of the 
population will undergo a qualitative study to assess acceptability of the intervention.  
6. PARTICIPANT IDENTIFICATION 
6.1. Study Participants 
For the main study participants will be 65 years or older who are attending physiotherapy for a 
musculoskeletal problem. For the qualitative sub-study and sub sample of the same population will be 
used in addition to physiotherapy staff that carried out the intervention.  
6.2. Inclusion Criteria 
• 
Participant is willing and able to give informed consent for participation in the study. 
• 
Male or Female, aged 65 years or above. 
• 
Referred to physiotherapy with a musculoskeletal problem  
• 
Able to converse in and read English  
6.3. Exclusion Criteria 
The participant may not enter the study if ANY of the following apply: 
• 
Any comorbidity that precludes exercising such as unstable angina, or acute illness  
• 
Dementia or cognitive impairment precluding the ability to follow an exercise programme 
• 
Patients referred to physiotherapy for post-surgery rehabilitation  
7. STUDY PROCEDURES 
This study will be a two arm feasibility randomised controlled trial. Participants will be randomised 
between usual care or the intervention arm which will consist of a brief behavioural assessment and 
recommended adherence strategies based on the outcome of the assessment.  

                       
 
                                                      
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This assessment will be based on the COM-B behaviour change model. This model posits that for 
behaviour to take place, a person needs the capacity, opportunity and motivation. On the basis of this 
assessment one or more of the following interventions may be suggested to the patient, 'review of 
exercise programme', 'review of method of delivery', 'cues', 'reminders', 'discussion of barriers and 
problem solving', 'motivational interviewing', 'decision balance sheets', 'behavioural contract', 'goal 
setting review and monitoring telephone call. These interventions and all study procedure are described 
below. Participants will be followed up at 6 and 12 weeks. Feasibility of recruitment, retention and 
acceptability of the intervention will also be assessed. A subsection of participants will also take part in a 
qualitative interview, this will explore participants experience of the trial intervention, in addition to the 
participants experience of attempting to adhere to an exercise programme. Participants will have 
consented to be contacted with the potential of being invited to take part in an interview study on their 
initial consent form. Potential participants will be contacted after they have finished their 12 week follow 
up appointment, if interested they will be supplied with a separate PIS designed for this sub-study. If 
they are happy to take part a time will be arranged for the interview to take place. Participants will be 
asked to give written informed consent using a separate consent form for this sub-study. In addition to a 
sub-sample of the study participants, a sample of physiotherapy staff who delivered the intervention will 
also be invited to take part in an interview.  Staff will be invited to participate after all participants have 
finished the intervention. If interested they will be supplied with a PIS designed specifically for staff for 
this sub-study. If they are happy to take part a time will be arranged for the interview. They will be asked 
to give written informed consent using a consent form designed for this sub-study.  
7.1. Recruitment 
Potential participants who are referred to physiotherapy will be sent an invitation letter, participant 
information sheet, reply slip and a free-post envelope with their appointment letter from the 
physiotherapy department. If participants are interested they will be requested in the invitation letter to 
contact the principal investigator via telephone, email or the reply slip which they can send back with the 
free-post envelope. Participants who respond will be given the opportunity to ask any questions that 
they feel relevant. They will also have at least 24 hours from receiving the information to decide if they 
wish to take part.  
7.2. Screening and Eligibility Assessment 
The maximum duration allowed between screening and recruitment will be three months. All referrals to 
the Nuffield Orthopaedic Centre, Physiotherapy Department will be screened by staff that routinely 
receive referrals and make appointments. Any referrals which are for people over 65 years old with a 
musculoskeletal condition will be sent an invitation letter as outlined above.  
7.3. Informed Consent 
If a potential participant agrees to take part, an appointment will be made to take informal consent prior 
to record baseline data. Where possible this will be made just prior to the participant’s physiotherapy 
appointment to minimise any disruption to the participant.  

                       
 
                                                      
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Written and verbal versions of the Participant Information and Informed Consent will be presented to 
the participants detailing no less than: the exact nature of the study; what it will involve for the 
participant; the implications and constraints of the protocol; the known side effects and any risks 
involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at 
any time for any reason without prejudice to future care, without affecting their legal rights and with no 
obligation to give the reason for withdrawal 
The participant will be allowed time to consider the information and the opportunity to ask questions 
about the study. Written Informed Consent will then be obtained by means of participant dated 
signature and dated signature of the person who presented and obtained the Informed Consent. The 
person obtaining consent will either be the Principal Investigator or another staff member of the 
Physiotherapy Research Unit, all of whom are GCP trained. A copy of the signed Informed Consent will be 
given to the participant and one copy to the medical notes. The original signed form will be retained at 
the study site. 
Qualitative sub-study  
Participants will have consented on their original consent form to be contacted with the potential of 
being invited to take part in an interview study. Potential participants will be contacted after they have 
finished their 12 week follow up appointment, if interested they will be supplied with a separate PIS 
designed for this sub-study. Participants will be given time to consider participation in this sub-study, up 
to 1 week, in addition to the opportunity to ask questions. If participants are happy to take part a time 
will be arranged for the interview to take place. Participants will be asked to give written informed 
consent using a separate consent form for this sub-study. This sub-study will also include physiotherapy 
staff who delivered the intervention.  Staff will be invited to participate after all participants have 
finished the intervention. If interested they will be supplied with a PIS designed specifically for staff for 
this sub-study. They will be given to time to consider participating, up to one week, in addition to the 
opportunity to ask questions. If they are happy to take part a time will be arranged for the interview. 
They will be asked to give written informed consent using a consent form designed for this sub-study.  
7.4. Randomisation, blinding and code-breaking 
Participants will be randomised on the basis of the physiotherapist that they are seeing. All 
physiotherapists involved in delivering treatment will be randomised at the start of the study to either 
deliver usual care or the intervention. This will take place using opaque sealed envelopes. Therefore 
participant will receive usual care or the intervention depending upon whose treatment list they have 
been placed on. The assignment of any patient to a physiotherapist is undertaken by administration 
staff. The investigator or other research staff are not involved in this process, and will not be able to 
influence treatment allocation.    
7.5. Baseline Assessments 
Baseline assessment will, where possible, take place immediately prior to the participant’s physiotherapy 
appointment, in order to reduce any burden on the participant. At baseline the following data will be 
collected:   

                       
 
                                                      
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• 
Demographics: Age, gender, condition referred for, marriage status, ethnicity  
• 
Tilburg Frailty Indicator (TFI)(33): This is a self-report measure of frailty, it consists of two 
sections, detriments of frailty and component of frailty, the latter being divided into physical, 
psychological and social components.  
• 
Physical Activity Scale for the Elderly (PASE) (34): This is a physical activity self-report 
questionnaire that takes around 5-10 minutes to complete.  
• 
EQ 5D 5L (35,36): This self-report questionnaire is a measure of health-related quality of life. 
• 
Self-Efficacy for Exercise Scale (37): This self-report scale measures self-efficacy expectations to 
continue to exercise in the face of barriers to exercise.   
• 
Exercise Regulations Questionnaire (BREQ-3) (38,39): This self-report questionnaire measures 
motivation for exercise, it measures forms of intrinsic and extrinsic regulation of exercise 
behaviour. 
• 
VAS self-rated capacity to exercise, confidence to exercise and motivation to exercise: 
Participants will be asked to rate their perceived capacity, confidence and motivation to exercise 
on a scale of 0-10, where 0 is no capacity/confidence/motivation’ and 10 is maximum 
capacity/confidence/motivation 
7.6. Subsequent Visits 
A six week and a twelve week follow up will take place; these follow ups will be a research visit and not a 
standard clinical appointment. At both the 6 and 12 week follow up appointments the following data will 
be collected. This appointment can be conducted at either the participant’s home, or within the 
physiotherapy department at the Nuffield Orthopaedic Centre.  
• 
Self-Reported Adherence: This is a self-report scale ranging from 0-10, where patient will be 
asked to rate their adherence over the previous six weeks, ranging from 0 = ‘no exercises 
performed’ to 10 = ‘all exercise performed as instructed’, this scale has been used in previous 
exercise adherence studies(42,43)  
• 
Exercise Adherence Rating Scale (EARS): This is a 6 item self-report questionnaire, that asks 
people to record the answer to 6 question on exercise adherence, on a 5 point Likert scale (40)  
• 
Exercise diary: This diary will have been completed post physiotherapy, recording the number, 
sets and reps of exercises that the patient has been undertaken.  
• 
Global rating of Change:  This is the participants’ perception of their change since their initial 
appointment; scores include ‘very much worse’ ‘much worse’, ‘a little worse’, ‘about the 
same/no difference’, ‘a little better’, ‘much better’, ‘very much better’  
• 
Physical Activity Scale for the Elderly (PASE) (36): This is a physical activity self-report 
questionnaire that takes around 5-10 minutes to complete.  
• 
EQ 5D 5L (37,38): This self-report questionnaire is a measure of health-related quality of life. 
• 
Self-Efficacy for Exercise Scale (39): This self-report scale measures self-efficacy expectations to 
continue to exercise in the face of barriers to exercise.   
• 
Exercise Regulations Questionnaire (BREQ-3) (40,41): This self-report questionnaire measures 
motivation for exercise, it measures forms of intrinsic and extrinsic regulation of exercise 
behaviour. 
• 
VAS self-rated capacity to exercise, confidence to exercise and motivation to exercise: 
Participants will be asked to rate their perceived capacity, confidence and motivation to exercise 

                       
 
                                                      
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on a scale of 0-10, where 0 is no capacity/confidence/motivation’ and 10 is maximum 
capacity/confidence/motivation  
Qualitative Interviews  
A subsample of the study sample will be invited to take part in an interview to determine if the 
intervention is acceptable to participants. This will take place after the participants have completed their 
12 week follow up.  
7.7. Discontinuation/Withdrawal of Participants from Study 
Each participant has the right to withdraw from the study intervention at any time. The attending 
investigator may also request the participant is withdrawn from receiving the study intervention. Where 
possible the participant will continue to be followed up. The PI (or delegated individual) will record any 
reason for withdrawal on the study CRF and the participant will be asked if the study team may use the 
data collected to the point of withdrawal and/or contact them for collection of patient reported follow 
up data. 
7.8. Definition of End of Study 
The end of the study will be the date of the last qualitative interview being conducted.  
8. INTERVENTIONS 
For those randomised to usual care, the physiotherapy session will continue as normal, the only change 
being that after physiotherapy participants will be asked to complete an exercise diary. For those 
randomised to the intervention, prior to their physiotherapy appointment they will be given a sheet with 
four short questions to answer.  This will be done whilst sitting in the waiting room before the 
physiotherapy appointment. Following this the participant will be called in and assessed as normal. As 
part of the treatment they will be given an exercise programme as standard within physiotherapy. 
Following the exercise programme the participant will be asked to answer a further seven short 
questions; depending on the answers to both sets of questions, and following any discussion based on 
the answers as required, the physiotherapist will suggest one or more adherence approaches form a list 
of suggestions. These are; Review of exercise programme; Review of method of delivery; Cues or 
prompts; Discussion of barriers and problem solving; Motivational interviewing, Decision balance sheets; 
Behavioural contract; Goal setting review; Monitoring telephone call; Reminders. These are described 
below. 
• 
Review of exercise programme: here the exercise programme the participant has been given can 
be reviewed with the physiotherapist. They will be able to demonstrate and pattern the exercise 
to the participant. It will be encouraged that the participant practices all sets and repetitions 
required with the physiotherapist. 
• 
Review of method of delivery: this involves reviewing the way in which information about the 
participants’ exercise is given to them, for example would the participant like their exercise 

                       
 
                                                      
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programme drawn out on paper, or perhaps they want to take a video on their phone. The 
participant will be asked how they would prefer to receive this information. 
• 
Cues or prompts: here it will be suggested that participants could use a cue or prompt to help 
them to remember to undertake their exercise programme, for example a post-it note in a 
location they will be in when they need to think about exercise.   
• 
Discussion of barriers and problem solving: here the therapist will discuss any potential barriers 
to undertaking exercise and attempt to suggest strategies that overcome those barriers; this 
could for example be a suggestion to do the exercise programme before sitting down at the end 
of the day, when it feels much hard to get up again and do it.  
• 
Motivational Interviewing: this is a style of counselling that attempts to review and resolve 
participants’ ambivalence. The motivation to change comes from the participant, rather than 
being imposed on them.  
• 
Decision balance sheets: here participants can complete a decision balance sheet with regard to 
undertaking their exercises. These sheets allow a person to record the pros and cons of 
undertaking a behaviour, or ‘what might happen if I do the behaviour’ versus ‘what might 
happen if I don’t’.  
• 
Behavioural contract: this involves the therapist and participant signing a contract regarding the 
behaviour (exercise programme) to be undertaken, e.g. I will exercise daily, 2-3 sets a day for 10 
repetitions of the exercises prescribed. It can also include a section on when, where and how the 
participant is going to do their exercise programme. 
• 
Goal setting review: this will involve reviewing the participants’ goal(s) and making sure it is clear 
how the exercises included in their programme relate to the goal(s), 
• 
Monitoring telephone call: if it is felt to be useful, participant can receive a telephone call to see 
how things are going, and to make any suggests that might help with regard to sticking with the 
exercise programme. 
• 
Reminders: if helpful, participants can be asked to set reminders, e.g. reminder on phone, or 
alarm to remember to undertake their exercise programme. 
To avoid contamination between the treatment groups, i.e. the chance that participants in the usual care 
group end up receiving elements of the intervention. The importance of non-contamination in the trial 
will be articulated to the physiotherapists delivering treatment. Additionally the physiotherapist 
delivering the intervention arm will be told not to discuss the intervention with colleagues in the 
department delivering the control arm. 
All participants in both groups will be asked to complete an exercise diary recording the number of sets 
and repetitions that they completed. This will form the basis of the adherence outcome at 6 and 12 
weeks after the initial treatment session.  The number of exercises, sets and reps will be compared 
against the number of exercises, sets and reps prescribed in the treatment session. A percentage score 
of adherence will be calculated, total number of exercises, sets and reps undertaken divided by the total 
number of exercises, sets and reps prescribed multiplied by 100 (Ex-undertaken/Ex-Prescribed X 100), 
e.g. if a participant is given 2 exercises to perform with 3 sets of 10 repetitions daily for a week, the total 
number of prescribed exercises would be 420 for that week (3(sets) x 10 (reps) x 2 (different exercises) x 
7 (number of days)); if the participant followed all their reps, sets and exercise for 6 days out of 7 and 

                       
 
                                                      
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then did not do anything for the 7th day, they would have completed 360 exercises. Therefore they 
would have an adherence percentage score of 85.71% (360/420 x 100).  
The only exception to the above is there is a small chance that the participant will not be given an 
exercise programme. Should this occur then the participant will have to be withdrawn from the study as 
it is obviously not possible to adhere to an exercise programme that you have not been given, therefore 
no outcome measure would be possible. It is not envisaged that this is likely to be a significant problem 
as the number of patients receiving no exercise from physiotherapy are negligible, but should this 
happen with any kind of regularity this information will be of use in assessing the feasibility of this 
project.   
Qualitative study  
In addition to the trial outlined above a qualitative study will also take place with a subgroup of 
participants (approximately n=15) and clinicians who delivered the intervention (approximately n=5). 
They will undergo one-one interview. The aim of the interviews will be to obtain views about the 
intervention and how it was delivered in addition to exploring the experience of those trying to adhere 
to an exercise programme.  
Training  
The physiotherapists delivering the interventions will undergo training before the start of the study. This 
training will cover  
• 
The premise of the COM-B model  
• 
The model’s definition of capability, opportunity, and motivation 
• 
How to use the trial paperwork to make an assessment of these three components  
• 
The adherence approaches that can be considered on the basis of the assessment       
9. SAFETY REPORTING  
9.1. Definition of Serious Adverse Events 
A serious adverse event is any untoward medical occurrence that: 
• 
results in death 
• 
is life-threatening 
• 
requires inpatient hospitalisation or prolongation of existing hospitalisation 
• 
results in persistent or significant disability/incapacity 
• 
consists of a congenital anomaly or birth defect. 
Other ‘important medical events’ may also be considered serious if they jeopardise the participant or 
require an intervention to prevent one of the above consequences. 

                       
 
                                                      
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NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the 
participant was at risk of death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe. 
9.2. Reporting Procedures for Serious Adverse Events 
A serious adverse event (SAE) occurring to a participant will be reported to the REC that gave a 
favourable opinion of the study where in the opinion of the Chief Investigator the event was ‘related’ 
(resulted from administration of any of the research procedures) and ‘unexpected’ in relation to those 
procedures. Reports of related and unexpected SAEs should be submitted within 15 working days of the 
Chief Investigator becoming aware of the event, using the HRA report of serious adverse event form (see 
HRA website). 
10. STATISTICS AND ANALYSIS 
10.1. 
Sample size  
The sample size for the feasibility randomised controlled trial will be 40 to 50 participants, allowing for 
up to 25 participants per group. Whitehead et al (41) suggests that pilot trials recruit 20 participants per 
group, or 25 participants per group, for an 80% powered main trial or a 90% powered main trial 
respectively, assuming a small effect size of 0.1 to 0.3  
10.2. 
Analysis plan 
This is feasibility RCT, therefore the aims relate to the feasibility of several components of the trial and 
whether a large scale RCT is possible. The following components will be analysed in relation to feasibility. 
• 
Recruitment – The number of recruited participants in the recruitment window will be clear, but 
additional information will be analysed, such as the number of participants screened to allow for 
the recruitment target to be met. Also the reason for non-entry into the trial will be recorded, in 
order to provide realistic expectations of recruitment for a future larger scale RCT.  
• 
Randomisation – Is randomisation acceptable to participants in this study? Does randomisation 
create comparable groups?  
• 
Intervention acceptability – Is the intervention acceptable to participants? Do any participants 
attempt to cross groups? These issues will be explored in more depth as part of the qualitative 
study. 
• 
Retention of participants – Drop outs and wherever possible the reason for drop out will be 
recorded. 
• 
Fidelity - The principal investigator will conduct fidelity checks, this will involve observing 
treatment sessions to check adherence to the protocol. 
10.3. 
Analysis of Outcome Measures 

                       
 
                                                      
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Participant characteristics will be summarised using descriptive statistics. Participants will be analysed on 
an intention to treat basis according to the group they were randomised to.  The outcomes will be 
analysed by comparing differences in mean scores. As this is a feasibility trial the main aim of the analysis 
is to review the aspects of feasibility given in the preceding section, and not to find statistically significant 
results to demonstrate effectiveness of the intervention. In the future if a larger scale RCT is undertaken, 
the primary outcome measure is almost certainly going to be the percentage of exercise adhered to, 
taken from participants exercise diaries. This outcome will be compared (mean scores) across both 
groups.  
Qualitative Interviews  
The data from the interviews will be analysed using thematic analysis, using six steps proposed by Braun 
and Clarke(42) transcribing the data, generating initial codes, searching for themes, reviewing themes, 
defining and naming themes and producing the report. Data will be transcribed from the audio 
recordings, whilst initial ideas are recorded. Then data will then be coded, before codes are grouped into 
themes. To aid in the process of data analysis NVIVO 10 (or later version) software will be used. This 
computer programme is designed for the analysis of qualitative data. It allows the collection, sorting and 
analysing of data from qualitative methods such as interviews.  
11. DATA MANAGEMENT 
11.1. 
Access to Data 
Direct access will be granted to authorised representatives from the Sponsor and host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
11.2. 
Data Recording and Record Keeping 
All study data (pseudonymised by study number) will be entered on to Microsoft Excel 2010 or SPSS 
(SPSS version 22.0 or newer) computer software using password protected files on a password protected 
OUH FT Trust or Oxford Brookes University computer. This database will be accessible only to members 
of the study team. The participants will be identifiable by participant number in the database and the 
code list will not leave the Physiotherapy Research Office at the Nuffield Orthopaedic Centre.  
The participants’ name and any other identifiable details will not be included in any study data electronic 
files. The code list linking the study participant number to the name of the participant will be stored 
separately on an encrypted file on a password protected NHS computer at the Physiotherapy Research 
Office in the Nuffield Orthopaedic Centre. Qualitative transcripts will use pseudo initials and all 
identifiable information regarding people or place will be removed from transcripts. Forms containing 
personal data such as the consent form or reply slip will be stored in a lockable filing cabinet in the 
research office and accessible to only research members involved in the study. The Physiotherapy 
Research office is always locked if no staff are present.  

                       
 
                                                      
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The research members will ensure that the participants’ anonymity is maintained. The study will comply 
with the Data Protection Act which requires data to be anonymised as soon as it is practical to do so.  
At the end of the study the site file will be archived in the Physiotherapy Research Unit at the Nuffield 
Orthopaedic Centre. The office is accessible to only research members and is locked when empty. The 
study master file will be stored securely in the office premises for 5 years. The study database will be 
archived in an encrypted folder and stored securely on NHS servers.  
12. QUALITY ASSURANCE PROCEDURES 
The study may be monitored, or audited in accordance with the current approved protocol, GCP, 
relevant regulations and standard operating procedures. 
13. ETHICAL AND REGULATORY CONSIDERATIONS 
13.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki. 
13.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 
13.3. 
Approvals 
The protocol, informed consent form, participant information sheet and any proposed advertising 
material will be submitted to an appropriate Research Ethics Committee (REC), and HRA for written 
approval. 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
13.4. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the 
REC Committee, HRA (where required) host organisation and Sponsor. In addition, an End of Study 
notification and final report will be submitted to the same parties. 
13.5. 
Participant Confidentiality 
The study staff will ensure that the participants’ anonymity is maintained.  The participants will be 
identified only by a participant ID number on all study documents and any electronic database, with the 
exception of the CRF, where participant initials may be added.  All documents will be stored securely and 

                       
 
                                                      
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only accessible by study staff and authorised personnel. The study will comply with the Data Protection 
Act, which requires data to be anonymised as soon as it is practical to do so. 
13.6. 
Expenses and Benefits 
Reasonable travel expenses for any visits additional to normal care will be reimbursed on production of 
receipts, or a mileage allowance provided as appropriate. 
13.7. 
Other Ethical Considerations 
The study does not involve participants who are not able to consent for themselves. 
14. FINANCE AND INSURANCE 
14.1. 
Funding 
The project is funded by the Physiotherapy Research Unit, Nuffield Orthopaedic Centre 
14.2. 
Insurance 
NHS bodies are legally liable for the negligent acts and omissions of their employees. If you are harmed 
whilst taking part in a clinical research study as a result of negligence on the part of a member of the 
study team this liability cover would apply. 
Non-negligent harm is not covered by the NHS indemnity scheme. The Oxford University Hospitals NHS 
Foundation Trust, therefore, cannot agree in advance to pay compensation in these circumstances. 
In exceptional circumstances an ex-gratia payment may be offered. 
15. PUBLICATION POLICY 
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 in accordance with the 
ICMJE guidelines and other contributors will be acknowledged. 
 
 

                       
 
                                                      
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17. APPENDIX A:  AMENDMENT HISTORY 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes made