Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study
Phase: NA
Conditions: Patella Dislocation, Patella Dislocation Recurrent
Sponsor: City, University of London

 
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Study protocol 
Individualised exercise for adults with an acute 
 lateral patellar dislocation: a feasibility study 
Short title: INDEX-KD: INDividualised EXercise for Kneecap Dislocations 
Date: 17/12/2018 
IRAS ID: 251913 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Abbreviations 
AE 
Adverse Event 
CONSORT 
Consolidated Standards of Reporting Trials 
ED 
Emergency Department 
GCP 
Good Clinical Practice 
HCPC 
Health and Care Professions Council 
LPD 
Lateral Patellar Dislocation 
MRC 
Medical Research Council 
MRI 
Magnetic Resonance Imagery 
NHS 
National Health Service 
NIHR 
National Institute for Health Research 
NPC 
New Patient Clinic 
PROM 
Patient Reported Outcome Measure 
RCT 
Randomised Controlled Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SAMPL 
Statistical Analyses and Methods in Published Literature 
SOP 
Standard Operating Procedure 
TBC 
To be confirmed 
TIDieR 
Template for Intervention Description and Replication 
 
 
 
 
 
 
 

 
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Contents 
Abbreviations ................................................................................................................... 2 
SECTION 1. ADMINISTRATIVE INFORMATION .................................................................... 5 
SECTION 1.1 Title ...................................................................................................................... 5 
SECTION 1.2. World Health Organisation Registration Data Set.................................................. 5 
SECTION 1.3. Protocol version .................................................................................................. 7 
SECTION 1.4. Funding ............................................................................................................... 8 
SECTION 1.5. Roles and responsibilities ..................................................................................... 8 
1.5a Contributorship ..................................................................................................................................... 8 
1.5b Sponsor and funder ............................................................................................................................... 9 
SECTION 2. LAY SUMMARY ............................................................................................... 9 
SECTION 3 INTRODUCTION ............................................................................................. 11 
SECTION 3.1 Background and rationale ................................................................................... 11 
3.1a Background .......................................................................................................................................... 11 
3.1b Rationale for this study ....................................................................................................................... 12 
SECTION 3.2 Objectives .......................................................................................................... 13 
3.2a Primary objectives ............................................................................................................................... 13 
3.2b Secondary objectives .......................................................................................................................... 14 
SECTION 3.3 Study design ....................................................................................................... 14 
SECTION 4 METHODS: PARTICIPANTS, INTERVENTIONS AND OUTCOMES ........................ 14 
SECTION 4.1 Study setting ...................................................................................................... 14 
SECTION 4.2 Eligibility criteria ................................................................................................. 14 
4.2a Inclusion and exclusion criteria .......................................................................................................... 15 
4.2b Study personnel .................................................................................................................................. 15 
SECTION 4.3 Intervention ....................................................................................................... 16 
4.3a Intervention – modifications .............................................................................................................. 18 
4.3b Intervention – concomitant care ........................................................................................................ 19 
4.4a Primary outcomes ............................................................................................................................... 19 
4.4b Secondary outcomes ........................................................................................................................... 19 
SECTION 4.5 Participant timeline ............................................................................................ 21 
SECTION 4.6 Sample size ......................................................................................................... 22 
4.6a Target sample size ............................................................................................................................... 22 
SECTION 4.7 Recruitment ....................................................................................................... 22 
4.7a Screening and eligibility assessment .................................................................................................. 22 
SECTION 5 METHODS: DATA COLLECTION, MANAGEMENT, AND ANALYSIS ...................... 23 
SECTION 5.1 Data collection methods ..................................................................................... 23 
5.1a Outcomes and time points at which they will be assessed ............................................................... 23 

 
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5.1b Baseline data collection ...................................................................................................................... 26 
5.1c Follow up data collection .................................................................................................................... 26 
5.1d Retention ............................................................................................................................................. 26 
5.2b Data storage during and after the study ............................................................................................ 27 
SECTION 5.3 Statistical methods ............................................................................................. 29 
5.3a Statistical Methods for analysing primary and secondary outcomes................................................ 29 
5.3b Missing data ........................................................................................................................................ 29 
SECTION 6 MONITORING ................................................................................................ 30 
SECTION 6.1 Data monitoring committee ................................................................................ 30 
SECTION 6.2 Harms ................................................................................................................ 30 
6.2a Adverse events .................................................................................................................................... 30 
6.2b Serious adverse events ....................................................................................................................... 31 
SECTION 7: ETHICS AND DISSEMINATION ........................................................................ 32 
SECTION 7.1 Ethical approval .................................................................................................. 32 
SECTION 7.2 Protocol amendments......................................................................................... 32 
SECTION 7.3 Consent .............................................................................................................. 32 
SECTION 7.4 Confidentiality .................................................................................................... 33 
SECTION 7.5 Declarations of interests ..................................................................................... 33 
SECTION 7.6 Access to data..................................................................................................... 33 
SECTION 7.7 Ancillary care ...................................................................................................... 34 
SECTION 7.8 Dissemination policy ........................................................................................... 34 
7.8a Study results ........................................................................................................................................ 34 
7.8b Authorship ........................................................................................................................................... 34 
REFERENCES ................................................................................................................... 34 
 
 
 
 
 
 
 
 
 
 

 
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SECTION 1. ADMINISTRATIVE INFORMATION 
SECTION 1.1 Title 
Individualised exercise for adults with an acute lateral patellar dislocation: a feasibility study 
SECTION 1.2. World Health Organisation Registration Data Set 
Data category 
Information 
Primary registry and trial 
identifying number 
Clinicaltrials.gov 
Trial registration number: To be confirmed (TBC) 
Date of registration in 
primary registry 
TBC 
Source(s) of monetary or 
material support 
MRes Clinical Research National Institute of Health 
Research (NIHR) Studentship Award 
Primary sponsor 
City, University of London 
Sponsor’s reference 
MRes/18-19/04 
Contact for public queries 
Colin Forde 
Physiotherapy Trauma Outpatients, Level 2, John 
Radcliffe Hospital, Oxford, United Kingdom, OX3 9DU 
Tel. 01865 221540 Email: Colin.Forde@ouh.nhs.uk 
Contact for scientific queries 
Colin Forde 
Physiotherapy Trauma Outpatients, Level 2, John 
Radcliffe Hospital, Oxford, United Kingdom, OX3 9DU 
Tel. 01865 221540 Email : Colin.Forde@ouh.nhs.uk 
Public title 
INDEX-KD: INDividualised EXercise for Kneecap 
Dislocations 
Scientific title 
Individualised exercise for adults with an acute lateral 
patellar dislocation: a feasibility study 
Countries of recruitment 
England 
Health condition(s) or 
problem(s) studied 
Primary and recurrent lateral patellar dislocation 
Intervention: 
Participants will be provided with up to 6 sessions of 
individualised physiotherapy over a maximum duration 

 
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of 3 months. Initially participants will be required to 
select their activity related goals from treatment. They 
will then commence a progressive exercise programme 
focussed on resolving acute knee impairments (i.e. 
swelling and reduced range of movement), improving 
lower limb strength and motor control, and facilitating a 
return to their activity related goals. The exercises 
chosen will be based on the physiotherapist’s 
assessment, adapted to the participant’s physical ability 
and agreed with the participant. Participants will be 
required to complete the exercises independently at 
least 3 times a week. Strategies to increase adherence 
will also be employed. 
Key eligibility criteria 
Ages eligible for study: ≥ 16 years of age 
Sexes eligible for study: both 
Attending the John Radcliffe hospital trauma and 
orthopaedic service New Patient Clinic (NPC) or trauma 
outpatient physiotherapy department with an acute first 
time or recurrent traumatic or atraumatic lateral patellar 
dislocation (LPD)  
Study type 
Type of study: Interventional 
Study design: Prospective observational cohort 
Phase: Feasibility 
Date of first enrolment 
January 2019 
Planned trial period 
9 months 
Target sample size 
15 
Recruitment status 
Pending 
Primary outcome(s) 
• Eligibility (proportion of participants with a 
diagnosis of LPD screened for eligibility who 
satisfy the eligibility criteria) 

 
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SECTION 1.3. Protocol version 
Date: 
10/12/2018 
Version: 
2.0 
Authors 
Colin Forde (CF), Mark Haddad (MH), Shashi Hirani (SH), 
David Keene (DK) 
Revision chronology 
Nil 
 
• Recruitment rate (proportion of eligible 
participants who consent to participate in the 
study) 
• Acceptability of the intervention (assessed by an 
internally designed participant satisfaction 
questionnaire and the proportion of participants 
lost to follow-up) 
• Adherence (proportion of scheduled 
physiotherapy sessions attended, and prescribed 
exercise sessions completed) 
Key secondary outcomes 
• Acceptability of outcome data collection 
(completion rates) of the following patient 
reported outcome measures (PROMs) at 3 
months: 
➢ Tegner Activity Score 
➢ Lysholm Knee Scoring Scale 
➢ EQ-5D-5L 
• Assess harms associated with participation in the 
study  
• Determine what assessment findings are 
consistent with a diagnosis of LPD 
• Assess delivery of the intervention 

 
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SECTION 1.4. Funding 
CF is funded by a NIHR Masters in Clinical Research studentship award. This protocol 
represents independent research funded by the NIHR. The views expressed are those of the 
authors and do not necessarily represent the views of the NIHR, National Health Service 
(NHS) or Department of Health. 
MH is supported by the NIHR (NIHR Programme Grants for Applied Research RPPG-1210-
12011). The views expressed in this publication are those of the author(s) and not 
necessarily those of the NHS, the NIHR or the Department of Health. 
SH is a Senior Lecturer in Health Services Research and Health Psychology at City, University 
of London, who support his research. The views expressed in this publication are those of 
the author(s) and not necessarily those of City, University of London. 
DK is supported by the NIHR (NIHR Post Doctoral Fellowship, Dr David Keene, PDF-2016-09-
056). The views expressed in this publication are those of the author(s) and not necessarily 
those of the NHS, the NIHR or the Department of Health. 
SECTION 1.5. Roles and responsibilities 
1.5a Contributorship 
Chief 
investigator: 
Dr Mark Haddad, Visiting Lecturer in Health Service Research, 
Honorary Senior Lecturer in Mental Health, and Senior Tutor for 
Research, City, University of London, Northampton Square, London, 
EC1V 0HB, United Kingdom. 
Tel. 020 7040 3521 Email: mark.haddad.1@city.ac.uk  
Student: 
Colin Forde, Physiotherapy Trauma Outpatients, Level 2, John 
Radcliffe Hospital, Oxford, United Kingdom, OX3 9DU.  
Tel. 01865 221540 Email: Colin.Forde@ouh.nhs.uk 
Co-investigators: 
 Dr Shashivadan Hirani, Senior Lecturer in Health Psychology / Health 
Services Research at the School of Health Sciences, City, University of 
London, Northampton Square, London, EC1V 0HB, United Kingdom. 
Tel. 020 7040 0880 Email: Shashi.hirani.1@city.ac.uk 
 

 
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Dr David Keene, University of Oxford, Nuffield Department of 
Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie 
Research Centre, John Radcliffe Hospital, Oxford, UK, OX3 9DU 
Tel. 01865 223121 Email: david.keene@ndorms.ox.ac.uk 
 
CF conceived the study idea. MH, SH and DK provided expertise on study design. All authors 
contributed to refinement of the study protocol and approved the final version of the 
protocol. 
1.5b Sponsor and funder 
The NIHR and City, University of London, had no role in study design and will have no role in 
implementation of the study, data collection and analysis, and decision to submit for 
publication. 
 
SECTION 2. LAY SUMMARY 
Background   
Kneecap dislocations are relatively common, accounting for approximately 3% of all sports 
related knee injuries. It occurs most often in mid to late adolescence, during sports and 
activities that involve twisting and changing direction. Commonly encountered problems 
after this injury include reduced activity levels, an increased risk of osteoarthritis of the 
kneecap joint in later life, and feelings of kneecap instability during sport and dynamic 
activities such as hopping and changing direction. After this injury 20-50% of patients will 
suffer another dislocation. 
There is a lack of evidence to support any one treatment for this condition but to help 
recovery most patients are referred for physiotherapy. The management of recurrent 
dislocation is more controversial as surgery is sometimes considered, but data we collected 
from our service shows that these patients are routinely referred for physiotherapy. 
The best form of physiotherapy remains to be determined. In the NHS, the average duration 
of physiotherapy after a first-time dislocation is between 7 weeks and 3 months and 

 
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typically involves advice and exercises to restore movement of the knee, improve balance, 
and strengthen the muscles on the front of the thigh. The duration and content of 
physiotherapy for recurrent dislocation in the NHS is unknown. In the medical literature, 
published exercise programmes are poorly described, making it difficult to determine if they 
have been appropriately designed and of sufficient intensity. This variability in the duration 
and content of physiotherapy may explain the poor outcomes in this predominantly young, 
active population following this injury. Determining the optimal rehab programme therefore 
is a research priority 
Aims of the research 
The aim of this study is to assess areas of uncertainty relating to the implementation of an 
individualised exercise programme for patients with a recent kneecap dislocation. This will 
help determine if a future larger study is feasible and inform the design and conduct of 
future research that would aim to optimise outcomes for people after a kneecap 
dislocation. 
Research plan 
We aim to recruit 15 participants with a recent kneecap dislocation from the John Radcliffe 
Hospital. Participants will be enrolled in the exercise intervention which involves up to 6 
physiotherapy sessions over a maximum of 3 months. Our exercise programme was 
designed using the best available evidence. The programme aims to increase leg muscle 
strength. There is also a focus on facilitating a return to the participant’s usual activities, 
which may include dynamic activities such as hopping and changing of direction. The 
dynamic exercises differentiates it from other published exercise programmes. Participants 
will be required to perform the exercises at least 3 times a week independently. Strategies 
to increase adherence to the exercise programme will also be used. 
The study objectives are to determine how many patients match our eligibility criteria, to 
determine the recruitment rate, and to assess the acceptability of the intervention to the 
participants. The feasibility of using eligibility criteria and collecting outcome measures that 
would be used in a future definitive study will also be assessed. 

 
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SECTION 3 INTRODUCTION 
SECTION 3.1 Background and rationale 
3.1a Background  
Lateral patella Dislocations are a relatively common injury of the knee, accounting for 
approximately 3% of sports related knee injuries.1 Incidence rates of primary LPDs range 
from 23.1 – 42 per 100,000 person years in the general population, are similar amongst 
males and females, and peak during mid to late adolescence.2, 3  
50-60% of LPDs result from sporting activities, with the majority of these occurring during 
multi-directional and pivoting sports.4, 5 The most common mechanism of injury is thought 
to involve a combination of knee flexion and femoral internal rotation on an externally 
rotated tibia,6 and has been compared to the non-contact anterior cruciate ligament 
mechanism of injury.7 
Recurrent LPD is a commonly encountered problem with 23-30% of patients suffering a 
recurrent LPD within 10 years.2, 3 In younger patients this is significantly higher with 
recurrent ipsilateral LPD rates of 50% reported in patients under 18 years of age at 20 years 
follow-up.8 Additional negative sequalae include reduced activity levels, 9, 10 an increased 
risk of patellofemoral osteoarthritis,11 and persistent feelings of instability. 12 
Due to a paucity of high-quality evidence the optimal management of LPD is unknown.13 
There are currently no published clinical guidelines to guide the treatment of this condition 
in the United Kingdom (UK). Current expert opinion recommends conservative management 
in the form of physiotherapy for first time LPD, in the absence of an osteochondral lesion or 
fracture, with surgical intervention reserved for recurrent LPD.14 These recommendations 
however are made by clinicians based in the United States and do not necessarily reflect 
current practice within the NHS. We collected data on all patients with a diagnosis of LPD 
attending the John Radcliffe trauma service in 2017. This revealed that 76/94 patients with a 
diagnosis of LPD were referred for physiotherapy. Of these, 32 were first-time LPDs, 41 were 
recurrent LPDs and 21 were unknown. This indicates that both first-time and recurrent LPDs 
are routinely referred for physiotherapy in an NHS setting.  
In the NHS, after a first-time dislocation, physiotherapy lasts on average between 7 weeks 
and 3 months and is comprised of advice, range of movement, proprioception and 

 
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strengthening exercises, but sport specific rehabilitation is rare.15 The duration and content 
of physiotherapy in the NHS for recurrent dislocations is unknown.  Reviews of conservative 
interventions for LPDs has been unable to determine the most effective form of treatment, 
citing a lack of adequately reported interventions and well-designed trials comparing 
exercise interventions.16, 17 
This absence of evidence to inform the design and conduct of rehabilitation programmes for 
this patient cohort may explain the poor outcomes in this predominantly young, athletic 
patient population.  Determining the optimum rehab programme therefore remains a 
research priority 
3.1b Rationale for this study 
Prior to conducting a future definitive trial, current Medical Research Council (MRC) 
guidelines for the development of complex interventions recommend conducting 
preliminary research to address areas of uncertainty, thereby informing the design and 
conduct of future research.18 
Our attempts to estimate the number of patients with an acute LPD matching our eligibility 
criteria attending the John Radcliffe trauma services has been limited by insufficient 
information available in the patient’s medical records. This study aims to address this by 
determining how many patients with a LPD diagnosis satisfy our eligibility criteria.  
Determining the recruitment rates will help estimate the duration of recruitment required 
for future studies. This is important given the difficulty in recruitment of participants to 
previous trials of conservative interventions for this condition in the UK.19, 20 
As outlined previously, there is a paucity of evidence to inform the content of rehabilitation 
programmes after a LPD.16, 17 There has been only one published Randomised controlled 
trial (RCT) comparing different exercise interventions19 which showed no clinically significant 
difference between general quadriceps strengthening exercise compared to vastus medialis 
specific strengthening exercise in a cohort of first-time LPD patients. Of note, there was an 
attrition rate of 52%, significantly limiting the utility of the results. The reasons for this are 
unknown but suggest aspects of the study design were not acceptable to the participants. 
Therefore, determining the acceptability of our intervention and data collection methods 
before a future definitive trial is important. 

 
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The poor reporting of interventions has been highlighted in a review of non-operative 
treatment for LPD.17 This makes it difficult to ascertain if the exercise interventions 
complied with current guidelines to optimise muscle strength.21 There was also wide 
variability in the exercises used. Only one study incorporated a running exercise into their 
programme and none reported using hopping, change of direction or sports specific 
exercises, or were inadequately described to determine if they did. This is particularly 
concerning as these are activities this patient cohort perceive to make their patella 
unstable12 and the majority of LPDs occur during sporting activities.22, 5 
Although more progressive exercise programmes have been recommended,23, 24 trials 
incorporating these programmes are absent.  
SECTION 3.2 Objectives 
The aim of this study is to address uncertainty relating to key parameters and 
methodological processes in implementing an individualised exercise programme for 
patients with an acute LPD. It will identify aspects of the research design that are 
suboptimal and if these can be refined.18 This will provide preliminary evidence on the 
feasibility of future research, and if feasible, inform the conduct of this research. 
Numerical targets for the primary objectives (e.g. 25% recruitment rate) to determine the 
feasibility of a future study have not been set. This is due to the small sample size and the 
difficulty in determining whether a larger scale study is feasible based on preliminary work, 
particularly as it is unknown a priori if the problems encountered can be resolved.  
3.2a Primary objectives 
• To determine the number of patients presenting with a diagnosis of LPD, screened 
for eligibility, who satisfy the eligibility criteria  
• To determine the recruitment rates of eligible participants 
• To determine the acceptability of the intervention to participants by using an 
internally designed patient satisfaction questionnaire and measuring the participant 
attrition rate (% of patients who fail to complete follow up data collection at 3 
months) 

 
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• To determine participant adherence by measuring the proportion of scheduled 
physiotherapy sessions attended and prescribed exercise sessions completed by 
participant self-reporting 
3.2b Secondary objectives 
• To determine the acceptability of outcome data collection to participants by 
measuring the completion rates of PROMs 
• Assess harms associated with participation in the study  
• To determine what assessment findings are consistent with a diagnosis of LPD.  
• Assess delivery of the intervention 
SECTION 3.3 Study design 
This study is a feasibility study as defined by the NIHR – a study conducted to provide 
further information about certain parameters to inform a future larger study, as opposed to 
a pilot study in which all aspects of a full study are conducted in a miniature form.25 
 
SECTION 4 METHODS: PARTICIPANTS, INTERVENTIONS AND 
OUTCOMES 
SECTION 4.1 Study setting 
Participants will be recruited from the John Radcliffe hospital only. Potential participants will 
be identified at the trauma service NPC or from referrals to the trauma outpatient 
physiotherapy department. Eligibility of potential participants identified at the NPC will be 
determined by a physiotherapist or orthopaedic surgeon working as part of the orthopaedic 
and trauma team. Eligibility of potential participants identified from referrals to the trauma 
outpatient physiotherapy department will be determined by CF. 
SECTION 4.2 Eligibility criteria 
To reflect current local practice where patients with a diagnosis of LPD are routinely 
referred to a conservative management pathway with physiotherapy, all participants ≥16 
years of age diagnosed with LPD by a member of the trauma and orthopaedic team will be 
considered eligible for the study.  

 
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4.2a Inclusion and exclusion criteria 
Inclusion criteria: 
 
• Male or female ≥16 years of age  
• Attending the John Radcliffe trauma and orthopaedic service NPC or referred to the 
trauma outpatient physiotherapy department 
• First time or recurrent LPD (traumatic or atraumatic) meeting the diagnostic criteria 
of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma 
and orthopaedic team.  
Exclusion criteria: 
• Concurrent anterior cruciate ligament or posterior cruciate ligament injury 
confirmed by negative Lachman’s and posterior drawer test or confirmed by 
Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament 
injury requiring application of a hinged knee brace or surgical repair; concomitant 
injury that would prohibit participation in the exercise intervention 
• > 4 weeks from injury to presentation to acute care (ED or trauma services) 
• Unable to give written informed consent 
• Previous surgery on the affected knee 
• Presence of fracture on plain radiograph including osteochondral fractures 
• Medial patellar dislocation 
• Considered inappropriate for referral to physiotherapy (by member of trauma and 
orthopaedic team assessing the patient) 
• History of severe neuromuscular or congenital disorders 
• Patients referred for orthopaedic opinion who are subsequently listed for surgery 
prior to completion of the study intervention 
• Unable to understand written or spoken English 
• Unable to attend physiotherapy sessions at the John Radcliffe trauma outpatient 
physiotherapy department 
4.2b Study personnel 
The intervention will be administered by Health and Care Professions Council (HCPC) 
registered physiotherapists. Physiotherapists will be provided with information on study 

 
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rationale, objectives and intervention in the form of a clinician handbook and will be 
required to attend either one-to-one or group practical training on administering the 
exercise intervention.  
SECTION 4.3 Intervention 
All participants will receive the study intervention in addition to standard management of 
acute LPD by the trauma and orthopaedic service at the John Radcliffe hospital. Typically, 
this involves the provision of a lateral buttress splint and referral to physiotherapy with no 
limitations on weight-bearing or knee range of movement. Patients may receive advice on 
pain management, gait re-training and instruction of basic knee exercise from a member of 
the orthopaedic team or physiotherapist working in the NPC. No attempt will be made to 
modify this but what has been delivered in addition to the study intervention will be 
recorded in the study treatment logs to help characterise what acute care was delivered 
overall.  
The intervention will be comprised of up to 6, one-to-one, physiotherapy sessions over a 
maximum duration of 3 months. 1 or 2 more sessions will be allowed only if deemed 
clinically essential. Additional sessions and the reasons for these will be recorded to 
understand if the intervention would need adapting for future studies. Less than 6 
physiotherapy sessions can be agreed with the participant if they are self-managing 
effectively and their goals have been achieved, (these stopping rules will be recorded). A 
treatment duration of up to 3 months is representative of current care in the NHS for first-
time LPD.15 Initial physiotherapy sessions will be 45-60 minutes and subsequent 
physiotherapy sessions will be 30 minutes as per local practice. 
The exercise intervention has been designed to address the biomechanics associated with 
the LPD mechanism of injury, improve common lower limb strength deficits in this patient 
population and facilitate a return to the participant’s desired activities which may include 
activities such as running, hopping and twisting. 
The LPD mechanism of injury is thought to result from a quadriceps contraction with the 
knee in a position of slight knee flexion, femoral internal rotation and tibial external rotation 
which forces the patella laterally.6, 7 This is supported by studies demonstrating peak lateral 
displacement of the patella at angles of 0-30° knee flexion in patients with patellofemoral 

 
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instability27 and increased contact pressures on the lateral aspect of the patella with femoral 
internal rotation and tibial external internal rotation.28 Movement patterns at the trunk and 
lower limb known to increase knee abduction loading29, 30 will also be targeted as increased 
knee abduction loading at reduced knee flexion angles during sport specific tasks is 
associated with other common knee injuries such as patellofemoral pain and anterior 
cruciate ligament injury.31 Correction of these movement patterns will be achieved by 
advising participants on correct technique during the performance of their exercise 
programme and through strengthening of the lower limb muscles that control these 
movements. 
Strengthening exercises will be a core component of the exercise intervention as reduced 
strength of the hip extensors, abductors and external rotators is associated with greater 
knee valgus during single leg drops landing,32 and reduced quadriceps strength is common in 
patients with a history of LPD4, 16 and a risk factor for the development of patellofemoral 
osteoarthritis.33 
To ensure the intervention is standardised, exercises prescribed to participants will be from 
a pre-determined list of exercises categorised into range of movement, strength and 
neuromotor exercises of progressive difficulty. Physiotherapists will also have the option of 
choosing one exercise not on this list if they feel it is necessary for the participant’s 
rehabilitation. This will be recorded in the study treatment logs. Exercises will be selected 
based on the physiotherapist’s assessment, and the participant’s preferences and activity 
related goals.  
To ensure progressive improvements in muscle strength, the prescribed dose of 
strengthening exercises will be in line with current guidelines.21 There is currently a lack of 
evidence to inform the most effective dose for exercises that incorporate sport specific and 
functional tasks such as agility, hopping and balance.34 Therefore, the dose of these 
exercises prescribed will be at the discretion of the physiotherapist and noted in the study 
treatment log. Patients will be required to perform the exercise programme independently 
a minimum of three times per week on non-consecutive days as recommended.21, 34 Initially 
when pain may limit participants attaining the prescribed exercise intensity for 
strengthening exercise, participants can perform their exercises more frequently if they find 
this beneficial. 

 
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The intervention will also incorporate simple behaviour change techniques known to 
increase participant adherence to exercise. These will include goal setting, provision of 
written instruction, and demonstration and participant practice of the selected exercises.35, 
36 Guidance and recommendations on how to implement these strategies into practice have 
been developed37, 38 and have informed the design of our intervention. 
At the initial assessment, participants will be required to select an activity related long-term 
goal. Short-term goals to be achieved by the next treatment session will be selected at all 
subsequent appointments except the last one. Participants will be facilitated in setting 
appropriate goals by their physiotherapist using recommended guidelines.37 
Written information will be provided in the form of a participant information booklet. This 
will contain information about the nature of their injury, self-management and guidance on 
the exercises to be completed.  Rationale for the intervention and proposed benefits 
associated with this will be re-emphasised throughout the intervention. 
Physiotherapists will demonstrate the selected exercises followed by participants. Feedback 
will be provided, and participants will be asked if they would like to be recorded performing 
the exercises on their smartphone to increase technique compliance. The patient will be 
asked about their intention to adhere. If the intention is low, the barriers to adherence will 
be elicited and strategies to overcome them will be explored (following the principals of 
patient centred goal setting). 
Participants will be provided with, and asked to complete, an exercise diary containing their 
exercises and guidance on achieving an effective dose. At the end of each session 
participants will be encouraged to ask questions, their understanding will be assessed and 
any clarifications needed will be provided. At each review session participant adherence and 
achievement of short-term goals will be reviewed and strategies to overcome any barriers 
will be explored 
4.3a Intervention – modifications 
In the event of increased pain or swelling while completing the exercise intervention 
participants will, where possible, be advised to complete less repetitions or sets while 
remaining within the prescribed set and repetition range of the exercise identified as 
provoking their symptoms, or to regress to the previous level of this exercise, until 

 
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symptoms are at a level the participant is happy to continue to exercise with. If a specific 
exercise cannot be identified as the cause of the symptoms, all exercises will be reduced to 
a level, or set and repetition range, the patient is happy to continue to exercise with. If it is 
not possible to continue exercising for that exercise session, advice about application of ice, 
analgesia and relative rest will be provided where necessary and the patient will be 
reviewed at the next exercise session. 
4.3b Intervention – concomitant care 
As the efficacy of the intervention is not in question, concomitant health care such as 
medication use will not be recorded, and other aspects of care will continue as usual. 
SECTION 4.4 Outcomes 
4.4a Primary outcomes 
• Eligibility defined as the % of participants with a diagnosis of LPD, screened for 
eligibility, who satisfy the eligibility criteria 
• Recruitment rates defined as the % of eligible participants who consent to 
participate in the study 
• Acceptability defined as the % attrition rate (participants who fail to complete follow 
up data collection at 3 months) and participant response to a patient satisfaction 
questionnaire 
• Adherence defined as the % of scheduled physiotherapy sessions attended and 
participant self-reported intervention adherence defined as the % of prescribed 
exercise sessions completed 
4.4b Secondary outcomes 
• Acceptability of outcome data collection by participants defined as the % completion 
of the PROMs outlined below.  
➢ The Tegner Activity Scale39 measures activity on a scale from 0-10, with higher scores 
indicating higher activity. It has shown good reliability and content validity in 
patients with acute patellar dislocation and prior dislocation/subluxation and shown 
to measure a distinct aspect of recovery demonstrated by its low correlation with 
knee specific and general health questionnaires in this cohort.40 It has previously 
been used to assess the effect of conservative management in patients with first 

 
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time LPD patients. 19, 41 It will be completed after informed consent has been 
obtained prior to the first physiotherapy session based on pre-injury activity levels 
and at 3 months after the first physiotherapy session based on their activity levels at 
that time. It will be administered as a patient completed questionnaire. The change 
in Tegner Activity Scale scores will be used for analysis. 
➢ The Lyhsolm Knee Scoring Scale was originally developed for patients with knee 
ligament injuries42 and subsequently revised.39 It is scored from 0-100 with lower 
scores indicating higher pain and disability. It has since demonstrated good test-
retest reliability in patients with first time LPD and prior subluxation/dislocation and 
was able to discriminate between those who subsequently developed recurrent 
instability and those who did not.40 It has been used to assess the effect of 
conservative management in patients with first time LPD19 and recurrent LPD.43 It 
will be completed after informed consent has been obtained prior to the first 
physiotherapy session and 3 months after the first physiotherapy session based on 
current knee symptoms at that time. It will be administered as a patient completed 
questionnaire. The change in Lysholm Knee scores will be used for analysis. 
➢ The EQ-5D is a commonly used quality of life questionnaire.44 It will be completed 
after informed consent has been obtained prior to the first physiotherapy session 
and 3 months after the first physiotherapy session based on current symptoms at 
that time. It will be administered as a patient completed questionnaire. The change 
in EQ-5D scores will be used for analysis. 
• Harms. For this study harms will be defined as any unfavourable sign or symptom 
related to completing the study intervention. The recording of harms has been 
recommended in feasibility studies to inform future research design and processes.45 
This will be measured from commencement of the intervention to 3 month follow-
up as outlined is section 6.2a. 
• Determine what assessment findings are consistent with a diagnosis of LPD. A 
member of the trauma and orthopaedic team will be required to assess the 
presence/absence of proposed assessment findings to include in the eligibility 
criteria for future studies as outlined in section 5.1. This will inform the feasibility of 
using these assessment findings in the eligibility criteria for future studies. 

 
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• Intervention delivery. Treatment logs will be analysed to record the duration from 
injury to commencing the intervention, the number of physiotherapy sessions 
received by participants, the duration of intervention and the exercises prescribed.  
 
Additional demographic data will be collected as part of the study. Further information on 
this and the time points for data collection are outlined in section 5.1 
SECTION 4.5 Participant timeline 
Participant time line schematic diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient with LPD, screened for 
eligibility criteria, participant 
information sheet provided 
Consent obtained, enrolled in 
study, baseline questionnaires 
obtained 
Excluded: did not 
meet eligibility 
Usual care 
Approach for consent 
Intervention (up to 6 session over maximum 
duration of 3 months) 
Completion of intervention, 
follow up data collection via 
postal questionnaires at 3 
months, study ends 

 
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SECTION 4.6 Sample size 
4.6a Target sample size 
Data we collected from the John Radcliffe trauma service for 2017 conservatively estimates 
31 LPD patients match our eligibility criteria and 51 LPD patients are of unknown eligibility, 
due to the required information not being available in the patient’s medical records. Of 
those of unknown eligibility, 23 are due to the direction of dislocation not being reported. 
As medial patellar dislocations are exceedingly rare46 a conservative estimate would be 54 
eligible participants per year and 27 for our planned recruitment period of 6 months.  
We aim to recruit 15 participants over 6 months. Recruitment will cease at the end of the 
designated recruitment period of 6 months or earlier if the target of 15 participants is 
achieved. 
Previous trials in the UK investigating conservative interventions for this condition have 
reported low recruitment rates but not explicitly stated what these rates were.19,20 This 
makes it difficult to estimate recruitment rates for this study and why it forms one our 
primary objectives. We feel a recruitment target of 15 participants is feasible due to our 
conservative estimate of eligible participants and the broader inclusion criteria in our study 
compared to previous studies. 19,20 
As this is a feasibility study, no power calculation has been performed. A sample size of 15 is 
a pragmatic choice. This has been used for a study similar to ours, a single group prospective 
study investigating the acceptability and feasibility of exercise for patients with endometrial 
cancer. 47 
SECTION 4.7 Recruitment 
4.7a Screening and eligibility assessment 
Clinic lists for the trauma and orthopaedic NPC will be screened for patients with a knee 
injury. Patients will be assessed by a member of the trauma and orthopaedic team as per 
their usual practice.  Patients subsequently diagnosed with a LPD will be assessed to see if 
they meet the study eligibility criteria (as described in section 4.2a). Eligible participants will 
be provided with the participation information sheet and asked if they wish to participate in 
the study.  

 
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Referrals to the trauma outpatient physiotherapy department at the John Radcliffe hospital 
will also be screened to identify additional potential participants (e.g. patients referred to 
physiotherapy directly from the Emergency Department (ED) and not seen in the trauma 
and orthopaedic NPC). Information packs, containing an invitation letter and participation 
information sheet, will be sent to potential participants with CF’s email address and phone 
number. The invitation letter and participant information sheet will advise that consent to 
participate in the study is strictly voluntary, ongoing and can be withdrawn at any time (as 
described in section 7.3). Patients interested in participating in the study will register their 
interest by telephone or email. An initial consultation to review eligibility criteria and obtain 
informed consent will be arranged at the time of their first physiotherapy appointment to 
limit participant inconvenience. 
Eligible patients who decline to participate will have their age and gender recorded. They 
will also be asked their reasons for declining to participate, and if given, these will also be 
recorded. This will allow us to compare the characteristics of those recruited and those who 
chose not to participate. Those who do not meet the eligibility criteria or who decline to 
participate will be referred to their local physiotherapy provider (including the John 
Radcliffe trauma outpatient department where appropriate) as they normally would. 
Informed consent for eligible participants who wish to participate in the study will be 
obtained as outlined in section 7.3.  
 
SECTION 5 METHODS: DATA COLLECTION, MANAGEMENT, AND 
ANALYSIS 
SECTION 5.1 Data collection methods 
5.1a Outcomes and time points at which they will be assessed 
Outcome 
Measurement 
Time point 
Demographics 
Age, sex, height, weight, affected knee, mechanism 
of injury (traumatic/atraumatic), 
previous history of ipsilateral patella dislocation, 
previous history of contralateral patella dislocation, 
Baseline 
 

 
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time from injury to presentation to acute care (ED or 
trauma services), family history of patella dislocation, 
employment status, level of education, ethnicity 
Assessment 
findings  
Presence/absence of the following on: 
• A convincing patient history of a visible 
deformity on the lateral aspect of the knee or 
a sensation of the patella ‘popping’ out of 
joint followed by spontaneous reduction  
• Presence of a haemarthrosis or joint effusion 
on clinical examination 
• Tenderness along the medial patellofemoral 
complex (tenderness at the following bony 
landmarks or at any point extending between 
these two points: at or just proximal to the 
medial epicondyle of the femur and the 
midpoint of the medial aspect of the patella 
extending to the junction of the medial 
quadriceps tendon and the patella)26 
• Apprehension on laterally directed force of 
the patella 
Baseline 
Eligibility 
% of participants with a diagnosis of LPD who meet 
the eligibility criteria 
Completion of 
study 
Recruitment 
% of eligible participants who consent to participate 
in the study 
Reasons for not consenting will also attempt to be 
collected 
Completion of 
study 
Adherence 
% of scheduled physiotherapy sessions attended 
 
 
 
 
Completion of 
intervention 
 
3 months 
post first 

 
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Participant self-reported % of prescribed home 
exercise sessions completed 
physiotherapy 
session 
Acceptability 
% attrition rate 
 
Patient satisfaction questionnaire 
Completion of 
study 
3 months 
post first 
physiotherapy 
session 
Follow up  
 
% of participants who consent to treatment who 
return 3 month questionnaires 
Completion of 
study 
Knee function, 
pain and 
instability 
Lysholm Knee Scoring Scale 
Baseline, 3 
months post 
first 
physiotherapy 
session 
Activity level 
Tegner Activity Scale 
Baseline, 3 
months post 
first 
physiotherapy 
session 
General health 
status 
EQ-5D-5L 
Baseline, 3 
months post 
first 
physiotherapy 
session 
Intervention 
delivery 
Duration from LPD to first physio session, initial 
injury management, number of physiotherapy 
sessions attended, number of physiotherapy 
appointments participants unable to attend/did not 
attend, duration of the intervention from enrolment 
to discharge, exercises and dose of exercise 
Completion of 
intervention 

 
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prescribed from treatment logs completed by 
therapists 
Harms 
Patient and staff reported adverse events including 
any recurrent patellar dislocation, subsequent listing 
for knee surgery for mechanical instability and any 
increases in pain or swelling resulting from the 
exercise intervention lasting > 1 week 
From 
beginning of 
intervention 
to 3 months 
post first 
physiotherapy 
session 
 
5.1b Baseline data collection 
All baseline data will be collected after informed consent to participate in the study has 
been obtained prior to the first physiotherapy session. Participants will be asked to 
complete a questionnaire at baseline to capture the demographic information and PROMs 
outlined in section 5.1a. Telephone or email contact will be used to obtain a score, where 
relevant, if baseline data collection is subsequently identified as being incomplete.  
5.1c Follow up data collection 
Follow up data collection will take place 3 months after the first physiotherapy session. For 
participants whose final physiotherapy appointment is within 1 week of this time, 
questionnaires will be administered after this appointment. Follow-up data collection for all 
other participants will be via postal questionnaire.  
At least one reminder, via telephone or email, will be sent to participants who do not return 
postal questionnaires. Telephone or email contact will be used to obtain a score if follow up 
data collection is subsequently identified as being incomplete. 
5.1d Retention 
Participants will be informed their participation is voluntary and they can withdraw at any 
time with no obligation to explain why and without affecting the quality of their care. CF will 
attempt to contact participants who wish to withdraw, or do not adhere to the exercise 
intervention, to determine if they are willing to participate in follow up data collection. 
Participants who withdraw from treatment but participate in data collection will not be 

 
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considered withdrawals. Participant data prior to withdrawal will be used unless the 
participant expressly refuses consent to use of this data. The reason to withdraw, if 
provided, will be recorded on the study withdrawal case report form. Participants may be 
withdrawn after enrolment by the authors if it is subsequently determined they do not meet 
the eligibility criteria. 
SECTION 5.2 Data management 
5.2a Data entry                                                                                                                                                
Each participant will be assigned a unique subject code/number. All study documents, 
except the signed consent form and contact details for postal questionnaires, will refer to 
the patient by their unique subject code/number only.  
Data from paper questionnaires, case reports forms and treatment logs will be entered by 
CF into an electronic database that will be password protected, and on computers at the 
John Radcliffe hospital, that are swipe card access for NHS employees only. 
Study personnel collecting data will be provided with detailed written information outlining 
how to record and store outcome data. This will include how to complete case reports 
forms, advice to complete case report forms in ink, to avoid use of correction fluid, the 
normal range of values where appropriate and how to store case report forms on site. 
Standard physiotherapy notes will be made in accordance with standard local practice and 
documented on the local electronic notes system (EPR). These will not include any data 
recorded for the study that is not routinely collected during standard practice. 
5.2b Data storage during and after the study 
All study documents will be stored securely in locked filing cabinets accessible by study staff 
and authorised personnel only. Any personal details (e.g. addresses for postal 
questionnaires) will be held separately to outcome data. Electronic data will be password 
protected and stored on computers with swipe card access for authorised personnel only. 
Follow-up outcome data will be collected from participants via stamped pre-addressed 
envelope to CF at the physiotherapy trauma outpatient department at the John Radcliffe 
Hospital 

 
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Any study related data transferred from CF to his supervisors will refer to participants by 
their unique code/number only and be transferred using an encrypted memory stick device. 
This data will be deleted as soon as it is no longer needed. 
Personal data will be stored for up to 12 months after the study and then destroyed. 
Anonymised research data will be stored securely at City, University of London for 10 years 
after the study has finished. 
Oxford University Hospital NHS Foundation Trust will collect information participant 
information from their medical records for this research study in accordance with our 
instructions. Oxford University Hospital NHS Foundation Trust will use the participant’s 
name, NHS number and contact details to contact participants about the research study, 
make sure that relevant information about the study is recorded for their care, and to 
oversee the quality of the study. Individuals from City, University of London and regulatory 
organisations may look at the participant’s medical and research records to check the 
accuracy of the research study. Oxford University Hospital Foundation Trust will pass these 
details to City, University of London along with the information collected from the 
participant and/or their medical records. The only people in City, University of London who 
will have access to information that identifies participants will be people who need to 
contact the participants to monitor the conduct of the study or audit the data collection 
process. The people who analyse the information will not be able to identify participants 
and will not be able to find out the participant’s name, NHS number or contact details.  
City, University of London is the data controller for the personal data collected for this 
research project. Participant personal data will be processed for the purposes outlined in 
this notice. The legal basis for processing participant personal data will be that this research 
is a task in the public interest. 
 

 
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SECTION 5.3 Statistical methods 
5.3a Statistical Methods for analysing primary and secondary outcomes 
Statistical methods and results will be reported, where possible, in accordance with SAMPL 
guidelines.48 All analyses will be conducted using the latest version of SPSS (IBM Corp. 
Armonk, NY).  
Eligibility, recruitment, acceptability and adherence will be described using descriptive 
statistics and expressed as integers and percentages where relevant.  
Tegner Activity scores will represent ordinal data. Baseline and 3 months post 1st 
physiotherapy session scores will be described using descriptive statistics using median and 
inter-quartile range. 
Lysholm scores will represent continuous data. Baseline and 3 months post 1st 
physiotherapy session scores will be described using descriptive statistics using mean and 
standard deviations if scores are normally distributed or median and inter-quartile range if 
data is skewed. 
EQ-5D-5L scores will represent continuous data. Baseline and 3 months post 1st 
physiotherapy session scores will be described using descriptive statistics using mean and 
standard deviations if scores are normally distributed or median and inter-quartile range if 
data is skewed. 
Patient satisfaction scores will be described using descriptive statistics. Ordinal data will be 
expressed using medians and inter-quartile ranges, and categorical data will be expressed as 
integers and percentages. 
Baseline characteristics and additional outcome data on intervention delivery and harms will 
be expressed using descriptive statistics. Continuous variables will be described using means 
and standard deviations for normal distributions or medians and inter-quartiles range for 
non-normal distributions. Categorical data will be expressed as integers and percentages. 
5.3b Missing data 
Missing data for each questionnaire and item level missingness will be reported to help 
select future study outcome instruments. 
 

 
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SECTION 6 MONITORING 
SECTION 6.1 Data monitoring committee 
A data monitoring committee will not be formed. The intervention is of a relatively short 
duration and not substantially different from ‘usual care’ and therefore considered to be of 
minimal risk. Oversight of the conduct of the study will be provided by MH, SH and DK.  
SECTION 6.2 Harms  
6.2a Adverse events 
For this study an adverse event (AE) will be described as any unfavourable sign or symptom 
related to completing the study intervention.  
This study involves rehabilitation after a recent LPD. No additional risks are foreseen 
compared to usual rehabilitation at the John Radcliffe Trauma Outpatient Physiotherapy 
department. 
Possible (expected) complications of rehabilitation are: 
Newly acquired or temporary increases in knee pain and knee swelling; delayed onset 
muscle soreness, persistent patellar instability and recurrent patellar dislocation. Some of 
these may require the need for further surgery. 
Symptoms such as delayed onset muscle soreness and increases in knee pain or swelling 
lasting less than 1 week that do not require medical attention will not be regarded as AEs, as 
these are common after commencing a new exercise regime post injury. These will be 
managed as outlined is section 4.3a and explained in the participation information booklet. 
In the unlikely event of a further patellar dislocation patients will be referred to the trauma 
and orthopaedic service for assessment and treatment. If physiotherapist become aware of 
any AEs while administering the intervention, whether the AE is related to the intervention 
will be determined by the physiotherapist and verified by CF in discussion with his 
supervisors. All AEs will be recorded on case report forms by the participant’s 
physiotherapist. 
AEs related to the intervention will also be recorded by participant reported questionnaire 
at 3 month follow-up. 

 
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6.2b Serious adverse events 
A serious adverse event (SAE) 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, or 
• 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. 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. 
A SAE arising due to completion of the exercise intervention during this study is unlikely.  If a 
SAE occurs during the period from commencing to finishing the exercise intervention, a SAE 
form must be completed by the participant’s clinician and forwarded to CF or one of his 
academic supervisors within 24 hours. CF in discussion with his supervisors SH, MH and DK 
will determine if the SAE is attributable to the intervention.  
Only SAEs that are: 
• 
Related to the study (i.e. they resulted from administration of any of the research 
procedures) and 
• 
Unexpected (i.e. not listed in section 6.2a as an expected occurrence) 
will be reported to the Research Ethics Committee (REC) who granted the study a 
favourable opinion approval and the study sponsor within 15 days of CF or his supervisors 
becoming aware of the event. It will be followed up until conclusion. If it is not deemed 
related to the intervention it will be recorded in the case report form. 
 

 
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SECTION 7: ETHICS AND DISSEMINATION 
SECTION 7.1 Ethical approval 
UK NHS ethical approval for this protocol and associated documents will be sought from the 
local REC prior to enrolment of the first study participant. The study will be conducted in 
accordance with ethical standards which include Good Clinical Practice (GCP) and the 
Declaration of Helsinki. 
SECTION 7.2 Protocol amendments 
Any amendments to the protocol after ethical approval that affect the safety of study 
subjects, scientific value of the study, conduct or management of the study will be classed 
as substantive. Decisions to implement substantive amendments to the protocol will be 
taken by members of the study team in conjunction with the study sponsor and 
communicated to the local REC and the Health Research Authority (HRA) within 3 days by 
means of an amendment form generated through Integrated Research Application System 
(IRAS). All protocol amendments will be accompanied by an appropriate amendment to the 
protocol version and date. If substantive amendments are made after enrolment of the first 
participant, these will be outlined in the final study report. 
SECTION 7.3 Consent  
Written consent will be obtained in accordance with GCP guidelines and by a researcher 
identified in the delegation log as being able to take consent. Participants will be informed 
about the study design, aims of the study and what it will involve for them. Participants will 
be informed the purpose of the study is not to assess the efficacy of the intervention. 
Participants will also be provided with written information in the form of a participant 
information sheet and offered an opportunity to ask questions. Participants will be offered 
time to consider their participation in the study should they wish to do. Participants will be 
informed their participation is voluntary and ongoing, and they can withdraw consent at any 
time with no obligation to explain why and without affecting the quality of their care.  
If participants are happy to proceed to enrolment in the study the consent form will be 
signed and dated by the participant and the researcher. A copy will be provided to the 
patient, a copy will be placed in the patient’s medical notes, and the original kept by the 
study team.  

 
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SECTION 7.4 Confidentiality 
The study staff will ensure participant’s anonymity is maintained. Each participant will be 
assigned a unique subject code/number. All study documents, except the signed consent 
form and contact details for postal questionnaires, will refer to the patient by their unique 
subject code/number only. All study documents will be stored securely in locked filing 
cabinets accessible by study staff and authorised personnel only. Only staff involved in 
running the study and responsible members from Oxford University Hospital Foundation 
Trust, the sponsor City, University of London, and other authorities that audit and quality 
assure health research the NHS will have access to this information. The study will comply 
with the Date Protection Act and GDPR protocols, which state all data should be 
anonymised as soon as it is practical to do so and stored in accordance to their guidelines. 
SECTION 7.5 Declarations of interests 
CF is in receipt of a MRes Clinical Research NIHR Studentship Award and employed by 
Oxford University Hospital Foundation Trust as a band 6 trauma outpatient physiotherapist. 
Competing interests: none. 
MH is supported by the NIHR (NIHR Programme Grants for Applied Research RPPG-1210-
12011) Competing interests: none. 
SH is supported by City, University of London and has funding for research from the Bart’s 
Charity, NIHR RfPB scheme, and the EPSRC. Competing interests: none. 
DK is supported by the NIHR (NIHR Post Doctoral Fellowship, Dr David Keene, PDF-2016-09-
056). Competing interest: none. 
SECTION 7.6 Access to data 
CF, MH, SH and DK will have access to an anonymised version of the dataset. 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. Upon 
completion of the study, and with participant consent, fully anonymised research data may 
be shared with other organisations and researchers. 

 
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SECTION 7.7 Ancillary care 
Any AEs related to the study intervention will be managed as outlined in section 5.2a. Any 
serious adverse events will be managed by standard local NHS pathways.  
SECTION 7.8 Dissemination policy  
7.8a Study results 
The study will be reported in line with the Consolidated Standards of Reporting Trials 
(CONSORT) guidelines for pilot and feasibility trials.45 The exercise intervention will be 
reported in line with the Template for Intervention Description and Replication (TIDieR) 
guidelines for reporting of interventions.49 
CF will initially write up the results as a dissertation for a Masters in Clinical Research at City, 
University of London. Following submission all authors will review and agree upon the final 
version to be submitted for publication to a peer reviewed academic journal. Submission for 
publication will be made regardless of study results. Participants will be asked if they wished 
to be informed of study results as part of the consenting process. 
7.8b Authorship 
Authorship will be granted in accordance with the International Committee of Medical 
Journal Editors’ guidelines.50 Contributors who do not meet these criteria will be 
acknowledged. 
7.8C Reproducible research 
The study will be prospectively registered on ClinicalTrials.gov. prior to enrolment of the 
first participant.  
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