A Study to Assess the Acceptability of an Online Weight Prevention Programme for New Kidney Transplant Recipients- The WEight Management in Renal Transplant Online Study (ExeRTiOn)
Phase: NA
Conditions: Kidney Transplant; Complications, Obesity, Physical Activity, Weight Gain, Health Behavior
Sponsor: King's College Hospital NHS Trust

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 1 of 19 
IRAS project ID: 241928 
 
 
 
 
 
PROTOCOL 
 
 
 
FULL TITLE: A study to assess the acceptability of an online weight prevention 
programme for new kidney transplant recipients - The wEight in Renal Transplant Online 
Study (ExeRTiOn). 
 
Short Title: The wEight management in Renal Transplant Online Study- ExeRTiOn 
 
 
Chief Investigator:   
Dr Sharlene Greenwood- Consultant Physiotherapist, King’s College Hospital. 
 
Student and Principal Investigator:  
Ellen Castle - Senior Renal Physiotherapist, King’s College Hospital 
 
Supervisors:  
 
1. Dr Sharlene Greenwood- Consultant Renal Physiotherapist, King’s College Hospital. 
2. Dr Joseph Chilcot- Health Psychology unit, Institute of Psychiatry, Psychology & 
Neuroscience (IoPPN) 
3. Professor Iain Macdougall, Consultant Nephrologist King’s College Hospital. 
 
Co-investigators: 
 
1. Dr Helen MacLaughlin- Consultant Renal Dietitian, King’s College Hospital. 
2. Fiona Sharples- Transplant Matron, King’s College Hospital. 
3. Emmanuel Mangahis- Senior Research Nurse, King’s College Hospital. 
4. Jennifer Barsana- Senior Research Nurse, King’s College Hospital. 
 
 
 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 2 of 19 
IRAS project ID: 241928 
This trial will be conducted in compliance with the protocol, GCP and the applicable 
regulatory requirements. 
 
Sponsor Representative: Liba Stones, R&D Manager, King’s College Hospital 
 
 
Funder:  King’s College Hospital 
 
Study Site: King’s College Hospital, London, SE5 9RS 
 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 3 of 19 
IRAS project ID: 241928 
 
Table of Contents 
1 
INTRODUCTION ............................................................................................................. 5 
1.1 
STUDY FLOW DIAGRAM ExeRTiOn ..................................................................... 6 
2 
BACKGROUND AND RATIONALE .............................................................................. 7 
2.1 
Primary Objective ....................................................................................................... 7 
2.2 
Secondary Objectives .................................................................................................. 7 
3 
STUDY DESIGN............................................................................................................... 8 
3.1 
Objectives and hypothesis: .......................................................................................... 8 
3.2 
The “exertion” Online Resource ................................................................................. 9 
4 
STUDY SCHEDULE ...................................................................................................... 10 
4.1 
Distress protocol ........................................................................................................ 11 
5 
CONSENT ....................................................................................................................... 12 
6 
ELIGIBILITY CRITERIA............................................................................................... 13 
6.1 
Eligibility criteria for the KTx recipient participants (n=10) .................................... 13 
6.1.1 
Inclusion criteria: ............................................................................................... 13 
6.1.2 
Exclusion criteria: .............................................................................................. 13 
6.2 
Eligibility criteria for the Transplant Health Care Professionals (n=5) .................... 14 
6.2.1 
Inclusion criteria: ............................................................................................... 14 
6.2.2 
Exclusion criteria: .............................................................................................. 14 
7 
RECRUITMENT ............................................................................................................. 14 
7.1 
Selection of Participants ............................................................................................ 14 
8 
STATISTICAL METHODS ............................................................................................ 15 
8.1 
Sample Size ............................................................................................................... 15 
8.2 
Statistical Analysis .................................................................................................... 15 
8.3 
Randomisation procedures ........................................................................................ 15 
9 
PATIENT AND PUBLIC INVOLVEMENT (PPI) ........................................................ 16 
10 FUNDING........................................................................................................................ 16 
11 DATA HANDLING AND MANAGEMENT ................................................................. 16 
12 PEER AND REGULATORY REVIEW ......................................................................... 16 
13 MONITORING AND AUDITING.................................................................................. 17 
14 INDEMNITY ARRANGEMENTS ................................................................................. 17 
15 ARCHIVING ................................................................................................................... 17 
16 PUBLICATION AND DISSEMINATION POLICY ..................................................... 17 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 4 of 19 
IRAS project ID: 241928 
17 REFERENCES ................................................................................................................ 18 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 5 of 19 
IRAS project ID: 241928 
1 
INTRODUCTION 
The primary aim of this project is to create an online weight management tool (Physical 
activity, weight management and cognitive behavioural therapy) to prevent significant weight 
gain following kidney transplantation. Designing the online interactive weight management 
resource for kidney transplant patients will involve patient and health care professional input 
through Qualitative methodology such as ‘Think-Aloud’ interviews and one-to-one semi-
structured interviews. This online resource will be called “exertion” and will be created by 
the research team, with technical support from the SPIKA Software Company.  
Results from this study will refine the resource, and lead to a study application for a 
randomised controlled feasibility trial where we plan to test the “exertion” online application.  
Therefore this project has potential to influence clinical practice for kidney transplant 
recipients. It will allow patients, who may not have routine access to physio or dietetic input 
to address weight gain with support.  A study flow chart summarising the project can be 
found below.  

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 6 of 19 
IRAS project ID: 241928 
 
1.1 STUDY FLOW DIAGRAM ExeRTiOn 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Study flow diagram. 
Creation of the “exertion” 
app by the research team with 
technical support from SPIKA 
Input from successful 
Weight management 
clinic resources 
Recruitment of participants: 
 10 KTx Recipients 
 5 HCP’s 
‘Think-Aloud’ Interviews and exposure to the resource: 
 5 KTx and 2 HCP recorded ‘Think Aloud’ interviews 
 Remaining participants (10 KTx and 3 HCP) exposure to 
website in lab session 
1:1 Semi-structured interviews 
5 HCP’s  
10 KTx R 
Further refinement of “exertion” application 
informed by patient and HCP data 
Prepare for feasibility RCT to test the “exertion” App. 
Technical support 
from SPIKA  
Technical support 
from SPIKA  
Qualitative data analysis 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 7 of 19 
IRAS project ID: 241928 
 
2 
BACKGROUND AND RATIONALE 
Physical activity and exercise play a beneficial role in maintaining the health of those with 
chronic illnesses however poor physical functioning among patients with chronic kidney 
disease (CKD) is well recognised (1, 2). Kidney Transplantation (KTx) is an effective 
treatment option for life threatening end-stage kidney disease and becomes cost-effective 
over the average lifespan of the transplant, although it is not without associated risk. The use 
of modern immunosuppression therapies have improved the life-expectancy of the kidney 
graft; however, there is a high prevalence of diabetes, cardiovascular disease and obesity (3, 
4). It has been established that recipients of KTx increase their physical activity level in the 
subsequent years after transplantation due to improved quality of life; however, within that 
time they do not reach the level of physical activity of those of age-matched healthy controls 
(5). A reason for this is that despite the reversal of many of the prevailing uraemic symptoms 
following KTx, functional capacity remains compromised due to a combination of prior 
deconditioning, uraemic myopathy, muscle atrophy and muscle pathology as a result of 
immunosuppression therapy (6, 7).   
 Weight gain is a significant and real issue for kidney transplant recipients (8, 9). Obesity 
remains a widespread issue for KTx recipients with an estimated two thirds of the population 
being overweight or obese (8). Research suggests that patients who gain more than 15% of 
their initial weight during the first year after receiving a kidney transplant, they have a higher 
chance of dying from conditions not related to their kidney function within ten years (9). 
Although weight gain and maintaining a programme of activity are real concerns for KTx 
recipients, they are not routinely offered specialist physical activity or weight management 
programmes in the UK.  There are some community schemes for exercise and weight 
management available.  However kidney transplant patients report they are not always 
understanding of the specific issues surrounding kidney transplantation.  Extra appointments, 
travel time, and return to work where highlighted as barriers to participate in our supervised 
kidney transplant study (10). Robust research reviews suggest that online behavioural weight 
management interventions can help people regulate food intake and activity, and on average 
can lead to clinically meaningful weight loss (11, 12). Therefore there is a need to create an 
online weight management and physical activity tool, specific to KTx recipients, imbedded 
with cognitive behavioural therapy and motivational interviewing methods to address post-
transplant weight gain. I would like to create this app with input from the research team, 
kidney transplant patients, and health care professionals (HCP’s) working in the transplant 
team at a South London Teaching Hospital. 
 
2.1  Primary Objective  
To create a patient focused online weight management and physical activity tool for new 
transplant recipients called “exertion”. 
2.2 Secondary Objectives  
 
a) To explore the current themes through qualitative data collection: 
 Components of the “exertion” resource that are helpful/ unhelpful 
 Any difficulties/ barriers to using the “exertion” application 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 8 of 19 
IRAS project ID: 241928 
 Any difficulties/ barriers to participating in the study? 
 Strengths of the “exertion” resource 
 Weaknesses of the resource 
 Patient experience and learning using the online resource 
 Transplant health care professional experience and knowledge reviewing the online 
resource 
 
3 
STUDY DESIGN 
This study is a qualitative study and intervention planning study to create and refine an online 
resource for weight management in new kidney transplant recipients, which will be named 
“exertion”. 
 
3.1 Objectives and hypothesis: 
The aim of this qualitative study is to use qualitative methods to create and refine a weight 
management, exercise/ physical activity online resource for patients with kidney transplant 
recipients. 
This study involves data collection via: 
 Think-aloud interviews- 5 KTx patients and 2 HCP working in the transplant team 
will have recorded think aloud interviews using the resources. Other participants will 
be exposed to the resource during a routine lab session. 
 Semi-structured interviews of transplant HCP’s and KTx recipients. 
 Demographic data including age, gender, occupation, smoking history, medical 
history, medication lists and baseline body weight (kg). 
 Website/ resource log in data  
 Field notes and observations from Think Aloud interviews, lab sessions and semi-
structured interviews 
 
We aim to recruit 10 new kidney transplant recipients and 5 transplant health care 
professionals to explore the following themes through ‘Think-Aloud’ interviews: 
 The functionality of the “exertion” online resource for KTx recipients 
 The functionality of the “exertion” online resource from a HCP perspective 
 KTx participants interpretation of the “exertion” modules and resource as a whole 
 HCP participants interpretation of the “exertion” modules and resource as a whole  
 Thought processes involved to use the “exertion” application 
 Recommendations from participants 
o Likes/dislikes 
o Barriers/ easier to use sections 
 Highlight individual differences in the use of the “exertion” resource 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 9 of 19 
IRAS project ID: 241928 
 
 
We aim to explore the following themes through semi-structured individual interviews and 
focus groups: 
 What components of the online resource (exertion) are helpful/ unhelpful from a 
kidney transplant perspective 
 What components of the online resource are helpful/unhelpful from a kidney 
transplant HCP perspective 
 Are there any difficulties/ barriers participating in the study?  
o And are they what were expected or different? 
 Patients experiences and learning using the online application, and when the changes 
were noticed 
 Anything missing/ they would recommend adding to the application. 
 
Trial duration per participant: One study visit. 
Estimated total trial duration: 9 months in total to create resource and have it reviewed by 
patients and health professionals (3 months to create, 3 months to test and 3 months to 
refine). 
 
3.2 The “exertion” Online Resource 
The “exertion” (exercise in renal transplant online) resource will be created by the research 
team, including physiotherapists and dietitians working in renal specific weight management, 
with technical software support from SPIKA Company. This is a single centre study at 
King’s College Hospital recruiting 10 kidney transplant recipients and 5 health care 
professionals from the transplant clinical team. As this study will involve patient interviews 
and qualitative data, ethical approval will be sought. 
The resource will include individually tailored physical activity (PA) (e.g.: walking and 
cycling), recorded using a pedometer or smart phone apps. PA will be based on current 
guidelines recommending a minimal amount of 1000 kcal/week expended for health benefits, 
with optimal benefits associated with 1500-2000kcal/ week. Dietary information from the 
existing weight management programme at King’s College Hospital (KCH) will be 
accessible to the patients online, including resources like “managing cravings”, “goal setting” 
and “problem solving”. The intervention will involve monthly web-based sessions that will 
start at 6 weeks post transplantation and continue until 12 months post-transplant surgery. For 
the purpose of this current study, participants will only have access to the online application 
in a one of session to review and refine the resource. It is clinical practice at our centre for 
KTx recipients to be cleared to resume structured physical activity post ureteric stent removal 
which occurs approximately 6 weeks post-surgery.  
The packages will focus on modelling prescribed PA and healthy eating advice, and will 
involve cognitive behavioural techniques to support behavioural change. Recognised 
behavioural change techniques will be used which will include goal setting, evaluating 
outcome expectancies and values, self-regulation action planning), and behaviour monitoring 
will form the core principles. The sessions will also aim to increase treatment self-efficacy 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 10 of 19 
IRAS project ID: 241928 
(physical activity) and reduce fear avoidance (using basic acceptance and commitment 
therapy principles). Tailored feedback will include encouragement and virtual rewards if 
maintaining weight. Weight gain will trigger initial referral to an automated recovery 
package. This package will be built into the interventional platform and automatically 
activate given an increase in weight. The nature of this package is to ensure that following 
weight gain, the patient remains engaged with this interventional programme and will provide 
additional behavioural support. The online tool will be accessible either online, or via a smart 
phone or tablet as a health application (app). 
 
We plan for the resource to allow participants to select modules to work through on a 
monthly basis over a 12 month period. Behavioural change tools and resources will be 
embedded within the “exertion” resource. For this current study, participants will access the 
online exertion resource at a one off supervised research visit. Participants will not have 
exposure or access to this online resource outside this study visit. The main modules will 
include information and interactive text on the following areas: 
1. Managing cravings and prednisolone 
2. Goal setting for activity and food planning 
3. Portion sizes and the NHS healthy plate 
4. Patient examples of strategies to plan activity (physical activity planning) 
5. Patient examples of strategies to eating out/ holidays with low fat diets (food 
planning) 
6.  Reading food labels and making healthy food choices 
7. Identifying barriers 
8. Problem solving 
9. Relapse prevention 
10. Planning for the future 
To ensure the modules are interactive, participants will be asked questions relating to: 
- 
Number of steps and self-reported physical activity levels 
- 
Weight, height, BMI  
- 
Portion sizes 
- 
Individual SMART goals regarding food and activity. The participants will be asked if they 
have achieved these set goals. 
- 
Problem solving questions for activity and food 
- 
Rating the importance and confidence in ability to make changes to food an activity using a 
VAS (visual analogue scale) 
 
4 
STUDY SCHEDULE 
 
Assessments: 
After written consent is received, participant’s demographic baseline information at entrance 
to the trial will be recorded.  5 of the KTx recipients and 2 of the HCP will undergo ‘Think-
aloud’ interviews to assess the usability of the exertion resource. Usability is defined as how 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 11 of 19 
IRAS project ID: 241928 
easily someone can use and interact with the online system without any formal training (13). 
‘Think-Aloud’ interviews are a qualitative research technique that assesses how the user 
interacts with the system and a sample of five can uncover 80% of usability problems and 
issues (13). ‘Think-aloud’ interviews provide a valid source of data concerning participant 
thinking as the participant is asked to vocalise as they perform a task, supervised by the 
researcher (14). Therefore in this study, the main researcher will record verbatim from 
participants as they talk out loud whist accessing and using the exertion resource. The 
researcher will also record field observation notes during the think aloud interviews. Verbal 
speech and site log in data will be recorded from these sessions. We estimate these interviews 
will take 60-90 minutes.  
 
The remaining participants (5 KTx and 3 HCP), will have the same amount of time reviewing 
the resource at the start of the session (60-90 minutes). After the ‘Think-aloud’ interviews or 
review of resources, participants will complete a one-on-one semi-structured interview to 
review their thoughts and experiences on using the exertion resource. Please refer to 
summary of study flow diagram on page 5 and schedule of assessment (Table 1) below.  
Having the semi-structured interviews on the same day as the ‘Think-aloud’ interviews or the 
reviewing of the resource will minimise patient burden and recall bias.  
 
Table 1- Schedule of Assessment 
Procedure 
Recruitment 
Visit 1 
Screening and  informed written consent 
X 
 
Medical history and demographics 
 
X 
‘Think-Aloud’ interviews: 
- 
5 KTx 
- 
2 HCP 
- 
Estimate 60-90 minutes total 
 
X 
Exposure to the resource lab sessions 
Estimate 60-90minutes total 
 
X 
Semi structured individual interviews 
(n=9 KTx, n=5 HCP) 
 
X 
 
 
4.1 Distress protocol 
As participants will be discussing exercise and food intake whilst using the online resource 
and during the semi-structured interviews the team have devised a distress protocol (modified 
from Distress Protocol for qualitative data collection, C.Haigh and G. Witham, Department of 
Nursing Manchester Metropolitan University). 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 12 of 19 
IRAS project ID: 241928 
 
Figure 2. Distress Protocol  
 
5 
CONSENT 
Patients will be screened and identified by clinicians working in the transplant team, and also 
the main researcher (EC). Potential participants will initially be provided with patient 
information sheet (the current Research Ethics Committee (REC) and Health Research 
Authority (HRA) approved version) and a covering letter explaining the trial to them and 
inviting them to participate in the trial. The research team will meet the potential participants 
face to face during their clinical visit to offer the patient information letter and cover letter. 
They will have time to consider the trial and decide whether or not they wish to take part, and 
to discuss the trial with their family and friends if they would like to. If they are non-english 
speakers, they will be offered the opportunity to discuss the study in detail and ask any 
questions via the language line phone translation service.  Transplant staff members will also 
be approached and provided with the information sheet, cover letter and ample time to 
consider consenting to the trial (a minimum of 24 hours). 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 13 of 19 
IRAS project ID: 241928 
 At their next clinic appointment, potential KTx participants will have plenty of time to 
discuss the trial further and to have any questions that they may have about the trial answered 
from a member of the research team. The nature and requirements of the trial will be 
carefully explained. The investigator will explain that there is no obligation for a potential 
participant to enter the trial, that trial entry is entirely voluntary, and that it is up to the 
potential participant to decide whether or not they would like to join. It will also be explained 
that they can withdraw at any time during the trial, without having to give a reason and that 
their decision will not affect the standard of care they receive. Any reasons for non-
participation will be recorded if the information is volunteered. 
 Participants if willing to participate will be consented as per the GCP guidelines. Only adults 
above the age of 18, with capacity to consent will be accepted into the study. Non-english 
speakers will be consented via language-line phone translation service. The participant and 
responsible clinician will sign the informed consent form and the responsible clinician will 
perform a final confirmation of eligibility. Informed consent will be obtained before any trial-
related procedures are undertaken. A copy of the signed informed consent form will be given 
to the participant. The original signed form will be retained at the study site in the 
Investigator Site File and a copy placed in the medical notes. A copy will also be sent to the 
Chief Investigator of the study. With KTx participant’s prior consent, their General 
Practitioner (GP) will also be informed of their participation of the study. 
6 
ELIGIBILITY CRITERIA 
Participants will be included based on the following inclusion and exclusion criteria. Those 
who are ineligible, or decline to participate will be captured on the secure and encrypted 
recruitment and screening log. 
 
6.1 Eligibility criteria for the KTx recipient participants (n=10) 
 
6.1.1  Inclusion criteria: 
 Adult patient (18 years+) 
 male or female 
 Able to provide written informed consent 
 < 3 months post-transplant. NB. Our team has decided to recruit patients within the 
first three months post transplants as most patients at our centre are not cleared to start 
a formal physical activity or exercise plan until they have ureteric stents removed 
which usually occurs at 6 weeks post-transplant surgery. 
 Access to Internet connected computer, smart-phone or tablet. NB. Our team has 
completed a waiting room survey and our patients often use internet to view their 
clinical blood results through "renal patient view", therefore do not perceive internet 
access as a barrier to this study. 
 A Body Mass Index (BMI) greater than or equal to 18.5 (healthy range). 
 
6.1.2 Exclusion criteria: 
 Age < 18 years of age 
 Pregnancy 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 14 of 19 
IRAS project ID: 241928 
 Unstable medical conditions such as angina, uncontrolled hypertension or diabetes, 
congestive cardiac failure, active myocarditis, cardiac arrhythmia, co-morbid 
catabolic condition, psychiatric illness. 
 Participated in a structured exercise or physical activity intervention in the last three 
months  
 BMI of less than 18.5 (classified as underweight) 
 Significant cognitive impairment preventing them from engaging with online 
interactive material 
 
6.2 Eligibility criteria for the Transplant Health Care Professionals (n=5) 
 
6.2.1 Inclusion criteria: 
 A nephrologist, kidney doctor, nurse or member of the multi-disciplinary team 
who actively work with kidney transplant patients at King’s College Hospital 
 Adult above 18 years of age 
 Able to provide written consent 
 Access to Internet connected computer, smart-phone or tablet. 
 
6.2.2 Exclusion criteria: 
 Pregnancy 
 Unstable medical conditions such as angina, uncontrolled hypertension or diabetes, 
congestive cardiac failure, active myocarditis, cardiac arrhythmia, co-morbid 
catabolic condition, psychiatric illness. 
 
7 
RECRUITMENT 
 
7.1 Selection of Participants 
All participants will be recruited from King’s College Hospital renal outpatients. Potential 
participants will be identified when presenting for their routine post-transplant hospital clinic 
visits by the transplant clinical team.  Patients who fulfil the inclusion criteria will have their 
eligibility confirmed by the research team. Each patient must meet all of the inclusion 
criteria, and none of the exclusion criteria at entry to the trial. After confirming eligibility, 
eligible patients will be approached by an appropriately trained member of the research team 
who routinely work in the transplant clinic, to ascertain interest in entering the study. This 
individual (likely to be either the PI or CI of the study) will give a comprehensive verbal 
explanation of the trial (explaining both the investigational and standard treatment options 
and highlighting any possible benefits or risks relating to participation). Time for questions 
throughout the discussion will be given and questions adequately addressed. Potential 
participants will also be given a written information sheet about the trial and be given 
sufficient time (providing they have received the patient information sheet and had at least 24 
hours to read and fully understand the implications of the trial) to consider the study 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 15 of 19 
IRAS project ID: 241928 
information prior to deciding whether to take part. Participants that agree to enter the study 
will then be asked to consent to undergo study assessments.  If the participant is willing to 
take part then they will be asked to sign the consent form with a member of the research team 
countersigning.  Screening logs will be kept on the secure “renal physio” drive and will be 
encrypted for confidentiality. All eligible and ineligible patients, plus those declining to 
participate will be logged on the secure screening log. 
 
Throughout the trial duration, participants will be encouraged to ask questions and will be 
reminded that they can withdraw at any time without their clinical care being affected. No 
payment is to be offered to the participants taking part in the trial. 
8 
STATISTICAL METHODS 
 
8.1 Sample Size 
We will interview a purposive sample of KTx patients to include a range of gender and age.  
We will aim to also recruit a purposive sample of kidney transplant HCP.  ‘Think-aloud 
interviews produce large amounts of rich data and it is suggested that site 80% of usability 
problems are identified with 5 think aloud interviews. Therefore this research team aims to do 
think aloud interviews on 5 KTx recipients and 2 HCPs.  
 Individual semi-structured interviews will utilise appropriate topic guides that will be 
developed and discussed with the patient advisory group, and the steering group. We will 
continue with individual interviews until we reach data saturation, there is no new data, no 
new themes, no new coding and we are able to replicate the study (15, 16).  
 
8.2 Statistical Analysis 
Baseline demographics of the patients will be described using summary statistics. Continuous 
variables will be summarised using the mean and standard deviation (SD) if approximately 
normally distributed. Continuous variables that are not normally distributed will be 
summarised using the median and IQR.  
Qualitative analysis: Data will be collected through in-depth feedback about our online 
intervention materials; field notes, individual interviews and ‘Think-aloud’ interviews.  
‘Think-aloud’ interviews will be used to elicit participants’ reactions to sessions of the online 
intervention; participants will be observed and asked to comment aloud on reactions to every 
aspect of the different sessions. Semi-structured interviews will explore participants’ overall 
impressions of the online intervention. These qualitative techniques will allow for themes and 
sub-themes to emerge. The website will be designed to record user entries, and observational 
field notes about participants' use of the intervention will also be collected. Individual 
interviews will be transcribed verbatim and analysed using an inductive thematic analysis 
approach (17), informed by techniques of grounded theory (15), including line-by-line open 
coding grounded in data and constant comparison of all instances of codes. Deviant case 
codes will be employed to ensure that perspectives that diverge from dominant trends are not 
overlooked.  
 
8.3 Randomisation procedures 
 There is no randomisation in this study.  

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 16 of 19 
IRAS project ID: 241928 
9 
PATIENT AND PUBLIC INVOLVEMENT (PPI) 
Patient and public involvement is crucial for developing and evaluating this resource. Our 
renal care group is fortunate to have a group of patients from across the Chronic Kidney 
Disease trajectory in our research group. They have reviewed all associated study 
documentations to ensure it is appropriate for patients. This group of patient experts will also 
assist in reviewing lay summaries for dissemination of research.  
 
PPI is crucial to this project to create and refine a resource for the patients by transplant 
patients and members of the transplant HCP team. 
10 FUNDING  
The research team has been awarded £25,000 to create the “exertion” resource through the 
King’s College Hospital charity fund. The team are in the process of applying to the Allied 
Health Professional Kidney Research UK (KRUK) Fellowship. If successful, this fellowship 
would cover the student’s salary, study fees. If the team are unsuccessful in securing the 
KRUK grant, this study will be absorbed by the renal rehab team with adjusted time-lines. 
11 DATA HANDLING AND MANAGEMENT 
All paper data recording sheets will be stored in lockable filing cabinets at the renal rehab 
team office for 5 years. Documents will also be archived using the secure iron mountain 
software. Electronic data spreadsheets will be kept on the private renal rehab team drive and 
will be password protected. All patient indefinable details (name, address, hospital number) 
will be removed in place of trial ID numbers. 
All staff involved in this research project will ensure data is handled with strict 
confidentiality in line with local trust policies. Data will be reviewed regularly by the student, 
and monitored by the supervisors. The lead researcher (EC) will transcribe all interviews. 
Information gathered from the online resource will be anonymised and protected by a secure 
log in feature. 
12 PEER AND REGULATORY REVIEW 
 
 
This study has been peer reviewed within KCH, by an independent and relevant peer 
reviewer/committee, the renal research governance board on the 11th of October 2017. The 
Sponsor has accepted these reviews as adequate evidence of peer review.  
 
  
The study was deemed to require regulatory approval from the following bodies (list). Each 
approval will be obtained before the study commences.  
• 
HRA 
• 
REC 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 17 of 19 
IRAS project ID: 241928 
13 MONITORING AND AUDITING 
The Chief Investigator will ensure there are adequate quality and number of monitoring 
activities conducted by the study team. This will include adherence to the protocol, 
procedures for consenting and ensure adequate data quality.  
 
The Chief Investigator will inform the sponsor should he/she have concerns which have 
arisen from monitoring activities, and/or if there are problems with oversight/monitoring 
procedures. 
14 INDEMNITY ARRANGEMENTS 
KCH will provide NHS indemnity cover for negligent harm, as appropriate and is not in the 
position to indemnify for non-negligent harm. NHS indemnity arrangements do not extend to 
non-negligent harm and NHS bodies cannot purchase commercial insurance for this purpose; 
it cannot give advance undertaking to pay compensation when there is no negligence 
attributable to their vicarious liability. The Trust will only extend NHS indemnity cover for 
negligent harm to its employees; substantive and honorary, conducting research studies that 
have been approved by the R&I Department. The Trust cannot accept liability for any activity 
that has not been properly registered and Trust approved. Potential claims should be reported 
immediately to the R&I Office. 
15 ARCHIVING 
During the study, all data will be kept securely and confidentially at the Renal Physio office. 
After the study has ended, paper data recording sheets, the Trial Master file and patient 
consent forms will be kept locked and secure for 5 years. All documents will be archived at a 
long term storage facility (Iron Mountain) for 5 years. Data spreadsheets will be encrypted, 
name and contact details removed, and stored on a private renal physio team folder with 
limited access. 
16 PUBLICATION AND DISSEMINATION POLICY 
The research team plans to disseminate the study research findings in the following settings: 
 Conference presentation of study process and resource design of “exertion” at either 
the American Society of Nephrology conference and the British Renal Society 
Conference  
 Conference presentation of study results at either the American Society of 
Nephrology conference or the British Renal Society Conference 
 Publication of the resource design of “exertion” resource 
 Publication of the study findings 
 
 
 
 

 
 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 18 of 19 
IRAS project ID: 241928 
 
 
 
17 REFERENCES 
 
1. 
Koufaki P, Greenwood SA, Macdougall IC, Mercer TH. Exercise therapy in individuals with 
chronic kidney disease: a systematic review and synthesis of the research evidence. Annual review of 
nursing research. 2013;31(1):235-75. 
2. 
Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane 
Database of Systematic Reviews. 2011;Oct 5(10):CD003236. 
3. 
Friedman A, Miskulin DC, Rosenburg IH, Levey AS. Demographics and trends in overweight 
and obesity in patients at the time of kidney transplantation. American Journal of Kidney Diseases. 
2003;41:480-7. 
4. 
Gordon EJ, Prohaska T, Siminoff LA, Minch PJ, Sehgal AR. Needed: Tailored Exercise Reimiens 
for kidney transplant recipients. American Journal of Kidney Diseases. 2005;45(4):769-74. 
5. 
Nielens H, Lejeune TM, Lalaoui A, Squifflet JP, Pirson Y, Goffin E. Increase of physical activity 
level after successful renal transplantation: a 5 year follow‐ up study. Nephrology Dialysis 
Transplantation. 2001;16(1):134-40. 
6. 
Barnett N, Mamode N. Kidney Transplantation. Surgery. 2011;29(7):330-5. 
7. 
Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, et al. Kidney disease as 
a risk factor for development of cardiovascular disease a statement from the American Heart 
Association Councils on kidney in cardiovascular disease, high blood pressure research, clinical 
cardiology, and epidemiology and prevention. Circulation. 2003;108(17):2154-69. 
8. 
Jezior D, Krajewska K, Madziarska B, Kurc-Darak D, Janczak D, Patrzalek K. Post transplant 
Overweight and Obesity: Myth or Reality? Transplantation Proceedings. 2007;39(9):2772-5. 
9. 
Vega J, Huidobro, E. J., De La Barra, S., & Haro, D. Influence of weight gain during the first 
year after kidney transplantation in the survival of grafts and patients. Revista medica de Chile. 
2015;143(8):961-70. 
10. 
Greenwood SA, Koufaki P, Mercer TH, Rush R, O'Connor E, Tuffnell R, et al. Aerobic or 
Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot 
Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial) [Published online ahead 
of print 22 July]. American Journal of Kidney Diseases. 2015:doi: 10.1053/j.ajkd.2015.06.016. 
11. 
Shaw K, O'Rourke P, Del Mar C, Kenardy J. Psychological interventions for overweight and 
obesity. Cochrane Database of Systematic Reviews. 2005;2:CD003818. 
12. 
Powell LH, Calvin JEr, Calvin JE, Jr. Effective obesity treatments. Am Psychol. 2007;62(3):234-
46. 
13. 
Benbunan-Fich R. Using protocol analysis to evaluate the usability of a commercial web site. 
Information & Management. 2001;39:151-63. 
14. 
Charters E. The use of Think-aloud Methods in Qualitative Research An Introduction to 
Think-aloud Methods. Brock Education Journal. 2003;12(2). 
15. 
Strauss A, Corbin J. Basics of Qualitative Research: Techniques and Procedures for 
Developing Grounded Theory. California, London and New Delhi: Sage Publications; 1998. 
16. 
Guest G, Bunce, A., & Johnson, L. How many interviews are enough? An experiment with 
data saturation and variability. Field Methods. 2006;18(1):59-82. 
17. 
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 
2006;3(2):77-101. 

 
ExeRTiOn Protocol version 3.0 – 6th March 2018       
 
 
Page 19 of 19 
IRAS project ID: 241928 
Appendix 1: PROTOCOL VERSIONS 
Version No 
Version Date 
Detail the reason(s) for the protocol update 
1.0 
31.10.2017 
Original protocol involved two phases: 1) designing resource 
and 2) Feasibility Randomised Controlled Trial to further test 
online resource. As per guidelines by the South-London REC 
committee, the research team has separated this study into 
separate applications.  
2.0 
11.01.18 
NA this is the current version of the protocol of the qualitative 
study to design the exertion resource 
3.0 
06.03.18 
Changes as per suggestions from the REC and HRA