Outcomes of a Pre-operative Exercise Regimen for Patients Undergoing Hand-assisted Liver Donor Nephrectomy and Transplantation
Phase: NA
Conditions: Kidney Transplant, Kidney Transplant Donor, Kidney Transplant Recipient
Sponsor: University of Manchester

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 1 of 23 
OPERATe Research Protocol 
RESEARCH PROTOCOL 
 
 
Outcomes of a Pre-operative Exercise Regimen for patients undergoing hand-
assisted live donor nephrectomy and Transplantation (OPERATe) 
 
Contents 
 
 
1) 
RESEARCH TEAM & KEY CONTACTS 
2 
2) 
introduction 
4 
3) 
Background 
4 
4) 
STUDY OBJECTIVES 
6 
5) 
STUDY DESIGN & PROTOCOL 
6 
6) 
STUDY PARTICIPANTS 
12 
7) 
OUTCOME MEASURES 
15 
8) 
DATA COLLECTION, SOURCE DATA AND CONFIDENTIALITY 
15 
9) 
STATISTICAL CONSIDERATIONS 
16 
10) MONITORING AND QUALITY ASSURANCE 
17 
11) SAFETY CONSIDERATIONS AND ADVERSE EVENTS 
17 
12) PEER REVIEW 
18 
13) ETHICAL and REGULATORY CONSIDERATIONS 
18 
14) STATEMENT OF INDEMNITY 
19 
15) FUNDING and RESOURCES 
19 
16) PUBLICATION POLICY 
20 
17) REFERENCES 
22 
 
 
 
 
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 2 of 23 
OPERATe Research Protocol 
 
1) RESEARCH TEAM & KEY CONTACTS  
Chief Investigator: 
 
Name: Gareth Kitchen 
 
Address:    
AV Hill Building,  
Manchester,  
M13 9PT 
 
Email: gareth.kitchen@manchester.ac.uk 
 
Telephone: 07977280019  
 
Co-investigator(s): 
 
Name: Hussein Khambalia 
 
Address:    
Manchester Royal Infirmary,  
Oxford Road,  
Manchester,  
M13 9WL 
  
Email: hussein.khambalia@mft.nhs.uk 
 
Telephone: 07450531853 
Co-investigator: 
Name: Zia Moinuddin 
 
Address:    
Manchester Royal Infirmary,  
Oxford Road,  
Manchester,  
M13 9WL 
  
Email: zia.moinuddin@mft.nhs.uk 
 
Telephone: 07711679756 
Co-investigator: 
Name: Tunde Campbell 
 
Address:    
Manchester Royal Infirmary,  
Oxford Road,  
Manchester,  
M13 9WL 
 
Email: tunde.campbell@mft.nhs.uk 
 
Telephone: 07792056907 
 
Co-investigator: 
 
Name: Sophie Collinson 
 
Address:    
Manchester Royal Infirmary,  
Oxford Road,  
Manchester,  
M13 9WL 
 
Email:  sophie.collinson1@nhs.net 
 
Telephone: 07766827099 
 
Co-investigator: 
 
Name: Raman Dhanda 
 
Address:    
Manchester Royal Infirmary,  
Oxford Road,  
Manchester,  
M13 9WL 
  
Email: raman.dhanda@mft.nhs.uk 
 
Telephone: 07954591579 
 
Co-investigator: 
 
Name: Anthony Wilson 
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 3 of 23 
OPERATe Research Protocol 
 
Address:    
Manchester Royal Infirmary,  
Oxford Road,  
Manchester,  
M13 9WL 
 
Email:  anthony.wilson@mft.nhs.uk 
 
Telephone: 07812521050 
 
Sponsor(s): 
 
Name: The University of Manchester  
Sponsor contact: Ms Lynne Macrae, Faculty 
Research Practice Governance Coordinator 
 
Address:  
Faculty of Biology, Medicine and Health  
5.012 Carys Bannister Building  
University of Manchester 
M13 9PL 
 
Email: FBMHethics@manchester.ac.uk 
 
Telephone: 0161 275 5436 
Lead R&D Trust contact(s): 
 
Name: Elizabeth Mainwaring 
 
Address:    
The Manchester University NHS Foundation Trust 
Research Office 1st floor 
The Nowgen Centre 
29 Grafton Street  
Oxford Road,  
Manchester,  
M13 9WU 
 
 
Email: R&D.applications@mft.nhs.uk  
 
Telephone:0161 276 3340  
 
 
 
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 4 of 23 
OPERATe Research Protocol 
 
2) INTRODUCTION 
This is a feasibility study to investigate the effectiveness of a prehabilitation programme for 
live renal transplantation donors and transplant recipients. Participants will undergo a 6 
week, at home exercise programme prior to their procedure. This programme of 
prehabilitation will be monitored using an exercise diary and wearable technology. The data 
will be utilised, along with participant feedback to assess their compliance and physiological 
effects of the exercise regimen.  
This study will inform the research group on the feasibility of bespoke prehabilitation 
pathways in transplantation, and how digital technology can inform this. The results of this 
will inform the grant application of a much larger study into the effects of prehabilitation in 
transplantation.  
 
3) BACKGROUND  
Prehabilitation programmes have been shown to have significant benefits for patients 
undertaking surgery in cardiothoracic, general and orthopaedic surgical procedures (1). 
Benefits include reduction in post operative complications, reduced morbidity and 
mortality, decreased post operative length of stay (LOS), faster recovery and return to work 
(1–7). These significant benefits have been found in a spectrum of interventions that 
concentrate on the three key principles of prehabilitation; exercise, nutrition and 
psychological support. However, there is a paucity of evidence supporting the use, and 
demonstrating the feasibility of a prehabilitation programme in transplantation (8).  
We already have evidence in other populations that decreased anaerobic threshold is a 
marker for being high risk for post operative complications (9). Therefore, acting within this 
period to improve physical fitness is perceived to improve post operative outcomes. 
Prehabilitation works by acting prior to the insult of surgery to improve a patient’s baseline 
characteristics, such as lean body weight, muscle mass and cardiorespiratory reserve.   
Live renal transplantation is an example of one of the most profound altruistic acts in our 
community. Therefore, it is vital that we optimise all stages of this journey, both in terms of 
preparation and post operative recovery of the recipient, and importantly for the donor. 
The aim of this would be to increase satisfaction, reduce post operative LOS, reduce time 
to being back to work (particularly for the donor who has no baseline medical condition 
prior to the surgery), and reduce post operative complications.  

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 5 of 23 
OPERATe Research Protocol 
Not all prehabilitation interventions have shown improvement in their study populations. 
There are multiple reasons for this, including drop out of exercise programs, or that control 
groups may significantly benefit from interventions that are meant to act as controls rather 
than intervention. An example of this includes a prehabilitation study in colorectal cancer 
that showed no difference between walking and cycling group, but the walking intervention 
control group did see an improvement in their function from baseline as they also increased 
their physical activity as part of the study (10). There is also the consideration that patients 
are not prepared appropriately for the intervention. Asking patients prior to surgery to 
participate in prehabilitation exercises without understanding the benefits they bring leads 
to poor compliance (10,11). This is particularly relevant to this study population who may 
experience post dialysis fatigue, deconditioning and baseline poor mobility (12).  
By creating an exercise program that is directly suitable to specific populations, studies have 
demonstrated this can remove some of the barriers to compliance, as well as leading to 
improved physical fitness and mental wellbeing (13). In the proposed study the use of 
electronic vital sign monitors with live feedback of results will act to reinforce the 
achievement that participants experience by engaging in a pre-surgical exercise plan. There 
is evidence for the use of wearable technology helping to deliver prehabilitation services in 
other surgical populations in a similar method that we aim to use (14–16).    
Ideally the behavioural change introduced by prehabilitation can be transitioned into the 
regular lives of patients. This would have a longer lasting impact on patients’ health and 
quality of life (17). This study provides an education and application that can be followed 
simply in participants own homes and fit around other commitments they have. The 
patients will be directed by the surgical team as to when physical activities can be restarted 
post-surgery.  
This study will provide key information into how the set-up of the trial and delivery of this 
service will be met. The study is not powered to detect statistically significant differences in 
outcome of the two groups, although statistical analysis will be performed to determine 
whether the impact of this intervention on its participants has led to a measurable change 
in physiological and clinical outcomes. This study provides the opportunity to test the set-
up of a new team, and how the wearable technology can be utilised in this cohort of 
patients. 
We will assess 4 key areas (18). First, we will evaluate the recruitment capability though the 
transplant team at MRI. This determines the ability and expected speed of recruitment of a 
much larger study. Secondly, this will evaluate and refine our data collection procedure in 
terms of data extraction, time for data collection and inform the need for future grants for 
research staff to be allocated time for OPERATe. Thirdly, this will evaluate the acceptability 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 6 of 23 
OPERATe Research Protocol 
and suitability of the intervention. As already discussed, exercise interventions for 
prehabilitation programmes have struggled previously with finding an acceptable method 
of exercise intervention, particularly one which participants will remain compliant with. 
Finally, this will provide a preliminary evaluation of participant responses to the 
intervention, in terms of improved post operative outcomes and patient satisfaction 
(18,19). Each of these key areas will provide important actionable information that will lead 
to a more refined and improved larger study, thereby saving time, funding, and limiting 
wasteful interaction with participants in the future (20).  
Funding 
Funding for consumer wearables has been provided by the Kidney for Life charitable fund.  
4) STUDY OBJECTIVES  
4.1 Primary Question/Objective:  
• Is it feasible for renal transplant patients and live kidney donors to participate in a 
prehabilitation programme in combination with a piece of wearable technology?  
4.2 Secondary Question/Objective:  
• Are transplant outcomes improved by prehabilitation regimens delivered by video 
instruction?  
• Are there discernible perioperative digital signatures provided by the wearable that 
link to outcomes?  
• Is the quality of perioperative sleep linked to outcomes?  
 
5) STUDY DESIGN & PROTOCOL 
This is a prospective study investigating the impact of prehabilitation in live kidney donors 
and their recipients.  
 
Duration 
Initially, the study will recruit patients over a 9-month period, or until all 10 live donor pairs 
(20 participants) have been recruited. During this time, participants will wear a wearable 
smart device (Oura ring, Withings watch or Corsano wristband) for 2 weeks to collect 
baseline data before engaging with a prehabilitation programme for 6 weeks. The devices 
will be worn for a further 6 weeks after surgery, leading to participants being involved for a 
total 14-week period. Finally, a 3-month period will follow the completion of data collection 
when data analysis and write up will be completed.  

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 7 of 23 
OPERATe Research Protocol 
5.1 Participants 
The study aims to recruit a minimum of 20, maximum of 40 participants, half of whom will 
be live donors for renal transplantation and hald of whom will be the recipients of the live 
kidney transplant.  
5.2 Study Intervention and/or Procedures  
Potential participants will be identified for by the renal transplant team in preoperative 
outpatient clinic. They will be provided with all information about the study in a participant 
information sheet and highlighted to the research team following completion of a consent 
to contact form.  
 
Interested participants will then be contacted by a member of the research team, no sooner 
than 24 hours later. If the potential participant is deemed suitable following telephone 
screening, and would like to enrol in the study, they will be invited to a face-to-face meeting 
with a member of the research team. This meeting will take place in The Wearables Lab, 
Manchester Royal Infirmary. The participant will complete the consent form. The 
participant will then need to go through the baseline exercise questionnaire and circadian 
rhythm questionnaire. The participant will be sized and given a wearable device to use. 
Sizing, comfort, and stock availability of the different devices will determine which device 
the participant receives. The participant will be given manufacturer’s instructions on the 
use of the wearable device (instructions in the box), charging it and when it is required to 
remove the device, for example devices are not MRI compatible. The participant will 
complete a hand grip strength test, which is a surrogate measurement for sarcopenia and 
important marker of frailty, measurements will be interpreted using both the International 
and European guidance on sarcopenia (24–26). They will then be instructed as to which 
exercise videos they should follow as part of their prehabilitation programme. The 
participant will be shown how to access the videos, how often they should use the video 
and given a folder of paper surveys and blank notebook to keep a ’patient journal.’ 
 
The participant will wear their chosen device for 2 weeks before starting the prehabilitation 
programme to allow for the collection of baseline data. On starting their programme, the 
participant will be asked to complete their exercise videos at least four times a week. After 
each time, the participant will complete a short paper-based survey of how they feel and 
their interaction with the video. Participants are encouraged to keep a patient journal on 
their thoughts/feeling during this study. Every 2 weeks a member of the research team will 
contact the participant by phone. This is to provide encouragement for their interaction 
with the study and any feedback from their device data. The participant may be instructed 
at this point to use a higher or lower intensity exercise video.  

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 8 of 23 
OPERATe Research Protocol 
 
On admission for surgery, a member of the research team will visit the patient pre-
operatively on the ward. Participants will submit their paper post-exercise surveys at this 
time. The participant will repeat the hand grip strength test and complete an end of 
prehabilitation questionnaire. The participant will remove their device during their 
inpatient stay.  
 
On discharge from hospital the patient will reapply their wearable device until their 6 week 
follow up appointment. At this point they will return their device, any outstanding surveys, 
and complete the final questionnaire.  
 
 
 
 
 
 
 
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 9 of 23 
OPERATe Research Protocol 
Study Overview: 
 
 
 
 
 
 
Study enrolment, consent, setting up with 
wearable device and exercise assessment. 2 
weeks wearing device to collect baseline 
data.
6 weeks of prehabilitation whilst wearing 
their device. Contact from the research 
team every 2 weeks to update on the 
prehabilitation programme. 
Live kidney transplantation, either as a 
donor or a recipient. Device is removed for 
surgery. End of prehabiliation programme 
questionnaire.
Discharge from hospital. Wearable is worn 
again for the next 6 weeks during recovery.
6 week follow up. Wearable device given 
back and end of study questionnaire 
completed. 
End of study

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 10 of 23 
OPERATe Research Protocol 
 
 
5.3 Prehabilitation exercise program  
 
 
 
Oura Ring 
The Oura ring is a commercially available wearable device. On enrolment to the study the 
research team will size and provide details on the ring to the participant. This includes how 
to use the ring and incidences when it should be removed. The participant will be asked to 
download the OURA ring app to their smart device so that the ring is able to upload its 
information.  
 
 
Initial Assessment
Questionnaire determining baseline level of function, frailty assessment and decision for which 
level of exercise program to begin with.
Approximately 1 hour in person assessment.  
Prehabilitation assessment 1
Assessment 2 weeks after starting prehabilitation 
Aim to review available data and instruct participant to continue at current exercise level, 
increase or decrease level. 
Approximately 15 minute phone call. 
Prehabilitation assessment 2
Assessment 4 weeks after starting prehabilitation 
Aim to review available data and instruct participant to continue at current exercise level, 
increase or decrease level.
Approximately 15 minute phone call. 
Completion of prehabilitation exercise program
Complete end of prehabiliation programme questionnaire. 
Approximately 30 minute questionnaire to complete. 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 11 of 23 
OPERATe Research Protocol 
Withings Watch 
The Withings watch is a commercially available wearable device. On enrolment to the study 
the research team will provide details on the watch to the participant. This includes how to 
use it and incidences when it should be removed. The participant will be asked to download 
the Withings Health Mate app to their smart device so that the watch is able to upload its 
information.  
 
Corsano Wristband 
The Corsano wristband is an FDA approved; CE marked wearable wrist device. On enrolment 
to the study the research team will provide details on the wristband to the participant. This 
includes how to use it and incidences when it should be removed. The participant will be 
asked to download the Corsano Research app to their smart device so that the wristband is 
able to upload its information. 
 
Data from all device applications is uploaded to the Cloud via Wi-Fi. Biometric data (heart 
rate, heart rate variability, respiratory rate, blood pressure, SpO2, core body temperature), 
activity data (step and workout count) and sleep data from the wearable devices will be 
extracted from the Cloud by a member of the research team. This will be stored on 
encrypted NHS Trust computers. Some of the information is available to participants 
through the relevant app. Should any of this be of concern to the participant they will be 
able to share this with their primary care team. A letter will be sent to each participant’s 
primary care physician on enrolment to the study.  
 
 
 
5.5 End of study  
 
The end of the study will be when the final participant has completed their 6-week post-
transplant review. Participants will complete their final questionnaire and be asked to 
return their wearable device and journal. This can take place during their scheduled 
outpatient appointment to prevent repeated returns to hospital for the participant. 
Following return, devices will be passed to the research team for cleaning and returned to 
factory status. Participants will not be entitled to keep their wearable device. 
 
An end of study notification will be submitted to the HRA within 90 days of the end of the 
study.  
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 12 of 23 
OPERATe Research Protocol 
6) STUDY PARTICIPANTS 
Study participants must meet all inclusion criteria. Meeting any of the exclusion criteria 
means that they would be unable to participate in the trial. Should any of the exclusion 
criteria take place after enrolment then the participant will be removed from the study.  
6.1 Inclusion Criteria:  
• Aged 18 years and over 
• Live kidney donor or transplant recipient 
6.2 Exclusion Criteria:  
• Deceased donor transplant recipient 
• Patients unable to wear or tolerate the wearable device 
• Unstable angina pectoralis, recent myocardial infarction, recent cerebrovascular 
accident, or new arrhythmia  
• Patient declines or is unable to participate in the exercise programme 
• Patient lacks capacity to give informed consent to participate in the trial  
• Non-English language  
• Patient has no access to a smart device to download the OURA/Withings Health 
Mate/Corsano Research Trials app 
6.3 Recruitment:  
Participants will be recruited at Manchester Royal Infirmary through the transplant team. 
The transplant team will identify candidates for recruitment from their outpatient work 
when reviewing potential donors and recipients for live kidney transplantation. At the time 
of identification potential participants will be provided with a participant information sheet 
to read about the study at a time convenient for them and complete a consent to contact 
form. Interested participants will then be contacted via a phone call after a minimum of 24 
hours has passed. The potential participant will verbally consent to be screened for whether 
they would be suitable for the trial.  
 
If a potential participant is deemed suitable for enrolment after telephone screening, they 
will be invited to an in-person meeting where they will be required to sign a consent form 
to be involved in the study. This meeting will take place in The Wearables Lab, Manchester 
Royal Infirmary. After completion of the consent form the participant will complete a paper-
based baseline exercise and circadian rhythm questionnaire and be allocated their device. 
The participant will be shown the prehabilitation exercise videos and instructed as to which 
video(s) they should be using as part of their initial prehabilitation. Participants will also 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 13 of 23 
OPERATe Research Protocol 
receive a folder of paper-based post exercise surveys and a blank notebook to keep an 
informal patient journal.   
 
 
 
 
 
 
 
6.4 Participants who withdraw consent [or lose capacity to consent]:  
Participants can withdraw consent at any time without giving any reason, as participation 
in the research is voluntary, without their care or legal rights being affected. There is no 
change to their usual management based on their participation, or withdrawal, from this 
study.  
Participants will be asked whether any pseudonymised data collected so far, can be used as 
part of the analysis of the study. Data would include wearable data (biometric, activity, 
sleep) and paper surveys linked to their study ID only. Links between their study ID and any 
identifiable data would be permanently erased at the time of consent withdrawal. 
Once full data collection has been completed, all data will be anonymised and no longer 
linked to a study ID. It would not be possible to remove individual participant data from the 
analysis of this trial after the point of anonymisation.  
Participants will continue to be involved with data collection after discharge from hospital, 
therefore any loss of capacity to consent during anaesthesia and/or whilst a patient on 
intensive care will be resolved at discharge. For any patient that may die during their 
Potential participant identified by the 
transplant team
Potential participant is contacted by a 
member of the research team and 
verbally consents to screening. 
Potential participant completes the 
screening questions and is suitable to 
be included in the trial. The participant 
must complete a written consent form. 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 14 of 23 
OPERATe Research Protocol 
admission, however unlikely, will also be included in analysis as this is an extremely 
important adverse outcome of surgery.  
Withdrawal from study 
The reasons why participants will be withdrawn from the study are as follows:  
• Participant’s decision to withdraw from the study 
• Investigator decision 
• Safety reasons  
• Severe non-compliance to protocol as judged by the investigator (participating in 
less than 50% of exercise sessions as monitored by their diary and wearable 
technology). 
If a participant decides to withdraw: 
• Monitoring with the wearable device will cease. 
• Participants will continue with the normal standard of care. 
6.5 Special circumstances 
The study team will counsel participants on safe use of their wearable device in accordance 
with the manufacturer's instructions. This will include circumstances when the device 
should be removed and any side effects the participant may experience. Participants will be 
provided with contact details for the study team so that they can contact the team if they 
have questions. This will be an email address and phone number through which the 
research team will be contactable 09:00-17:00 Monday to Friday.  
6.6 Training and support for participants 
Participants will be given detailed instructions on their wearable device and initial 
troubleshooting will be provided. Participants will be provided with a telephone number 
and study email address should they have any difficulties using their device or interacting 
with the software.  
There is a small possibility that the participant may become concerned when reviewing their 
own vital sign data on their smart device. In this case the participants will be encouraged to 
contact the research team via telephone and/or email address. Participants will then be 
signposted to the appropriate service if necessary. In some cases, participants will be able 
to show their device data on their smart phone to their primary care physician, if required.  
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 15 of 23 
OPERATe Research Protocol 
7) OUTCOME MEASURES  
This is a feasibility study, the results of which will inform the development and planning of 
a much larger clinical study into prehabilitation in live renal transplant patients and the use 
of wearable technology to augment this. The hypothesis is that prehabilitation may have a 
significant positive impact on the outcomes for recipients and donors in live kidney 
transplants.  
This study will examine the interaction between participants and the prehabilitation 
exercise videos, the set up for this additional service within the transplantation team and 
test the methods of data extraction.  
This study will perform data analysis which may show benefit of prehabilitation for kidney 
transplant recipients and live donors, although this is not powered. 
 
8) DATA COLLECTION, SOURCE DATA AND CONFIDENTIALITY 
8.1 Recruitment 
Consent to contact, screening proformas, consent forms, all questionnaires and patient 
journals will be retained in the study documentation. A copy of consent form will also be 
uploaded to their electronic patient records.  
8.2 Questionnaires 
Questionnaires will be completed in writing. Questionnaires will then be stored with the 
study information by the PI in a locked cabinet. After completion of the questionnaire these 
will be given to the PI at the earliest opportunity. Answers from the questionnaire will be 
transcribed into pseudonymised data collection tools.  
8.3 Data Extraction  
Demographics, current and past medical history, social status, planned operation date, 
medications, GP information and operation notes will be accessed through electronic 
patient records with their informed consent. This data will be pseudonymised and linked to 
their assigned study ID only. At the end of the study, when full data collection is complete 
study IDs will be removed, and data fully anonymised prior to analysis.  
8.4 Oura ring/Withings watch/Corsano wristband 
Only relevant data from the participant’s wearable device will be accessed from the Cloud 
by a member of the research team with their informed consent. Relevant data includes 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 16 of 23 
OPERATe Research Protocol 
biometric (heart rate, heart rate variability, respiratory rate, blood pressure, SpO2, core 
body temperature), activity (step and workout count) and sleep data.  
8.5 Data Management 
• Participants will be assigned a study ID at the time of informed consent taking, only 
known to the research team. A key linking personalised details (name and NHS 
number) to the study ID will be stored as an encrypted file on NHS Trust platform, 
only available to those in the research team.  
• Data will be pseudonymised via the individual ID whilst data collection for this study 
is being conducted  
• Data will be fully anonymised after data collection has been completed and the ID 
key permanently deleted. 
• Anonymised data from this study will be held by the principal investigator for 5 years 
after the completion of this study.  
• Data will be held under password protected files on password protected NHS trust 
computers.  
• Only data pertinent to this study (mentioned above) will be extracted from the 
wearable devices via the Cloud. 
• Following return of devices at the end of participant involvement, they will be 
restored to factory settings.   
• No hard or soft data copies will be transferred to University of Manchester (UoM).  
• Study data and materials may be looked at by UoM individuals, from regulatory 
authorities or the NHS trust for monitoring and auditing purposes.  
 
9) STATISTICAL CONSIDERATIONS 
9.1 Statistical Analysis 
9.11 Study analysis 
All variables will be explored descriptively with graphs and summary statistics. Key 
characteristics, such as overall recruitment, compliance with the prehabilitation 
programme and qualitative analysis of responses to open questions will be used to assess 
the primary research question.  
Description analysis will be performed on all appropriate variables, within the limits of an 
unpowered study. This will include number (%), mean, median, maximum and minimum 
values, standard deviation and interquartile range. 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 17 of 23 
OPERATe Research Protocol 
The number of potential participants screened, the number enrolled, withdrawals and 
completion of study will all be listed outcomes.  
Qualitative values, such as post operative complications will be listed. 
9.12 Thematic Analysis 
Where possible, depending on the quality and quantity of responses, anonymised free text 
answers to questionnaires or direct quotes from patient journals will be analysed through 
thematic analysis. The framework method will be used to examine for themes within 
participants responses (27). This involves the researcher immersing themselves in the data 
to familiarise themselves. Next themes and codes will be drawn from the data before 
charting and summarising the data. A matrix will be used to summarise the data before 
interpretations are drawn from this. This analysis will then be included in the write up with 
anonymised quotations, where suitable.  
9.2 Sample Size:  
This is a feasibility study to assess the role and interaction between prehabilitation services 
prior to transplantation and the use of wearable technology to augment this. Therefore, a 
power equation has not been used. The results of this study and its feasibility will indicate 
the need and success of a successive powered study. A provisional sample size of 10 donors 
and 10 recipients of live renal transplantation has been deemed suitable to determine the 
success of a successive trial. This is in part limited by the availability of wearable devices to 
run this study. 
 
10) MONITORING AND QUALITY ASSURANCE  
The responsibility for monitoring the study and its quality assurance is the chief investigator 
(CI) Dr Gareth Kitchen. Vital sign data will be monitored and commented upon at two-week 
intervals as per the study protocol. Each participant will be closely monitored by the 
transplant team, as per their usual standard of care. The research team will meet every 3 
months to monitor the study for recruitment and discussion of any adverse events. 
 
11) SAFETY CONSIDERATIONS AND ADVERSE EVENTS 
Adverse events (AEs) will be recorded by investigators during any face-to-face interactions 
and during the fortnightly telephone reviews. These events will be documented on the CRF 
and reported to the CI. Participants will be requested to contact the research team via 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 18 of 23 
OPERATe Research Protocol 
phone or email to highlight any AEs that arise between interactions. The research team will 
meet to discuss AEs every 3 months, or sooner should any urgent safety measures arise.  
Possible adverse events (as per separate risk assessment):   
• Localised skin irritation or dermatitis  
• Injury, exacerbation of underlying medical condition, slip or fall 
• Inappropriate fit, catching environment/clothing  
• Minor electric shock  
Any new underlying pathology that is identified through this study will be highlighted to the 
transplant team that is primarily involved in the patients care.  
Participants will be advised that they should stop exercising if they begin to feel unwell, that 
they let someone know and take usual medications as appropriate (such as salbutamol 
inhaler or GTN spray if they are already prescribed them), and to call 999 if none of the 
above help. This is the same as a participant would do if exerting themselves during their 
normal activities. 
The CI is responsible for:   
1. Receiving and assessing AEs and adverse reactions, noted by the research or clinical 
teams 
2. Reporting AEs and urgent safety measures to the sponsor and REC as per the 
requirements of the Research Ethics Service  
3. Maintaining a log of AEs occurring during the study and making this available to the 
sponsor on request. 
Cutoff date for recording of SAEs will be at the participant 6-week post-operative follow 
up outpatient appointment when wearable devices will be removed and returned to the 
clinical team.  
12) PEER REVIEW  
Input for the design of this study has been taken from the prehab for cancer (P4C) team 
from their varied experience in setting up prehabilitation services for patients awaiting 
cancer related surgery in the Northwest, whilst wearing Oura ring and Withings watches. 
 
13) ETHICAL and REGULATORY CONSIDERATIONS  
13.1 
Approvals  
NHS REC and HRA approval will be obtained before commencing research. The study will be 
conducted in full conformance with all relevant legal requirements and the principles of the 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 19 of 23 
OPERATe Research Protocol 
Declaration of Helsinki, Good Clinical Practice (GCP) and the UK Policy Framework for Health 
and Social Care Research 2017.  
 
13.2 
Risks   
13.21 Risk related to exercise 
 
Risks to participants will be minimised by careful selection criteria. Those at risk of cardiac 
ischaemia or arrhythmia are excluded from this study as participants will be undertaking 
unsupervised exercise. Each participant will complete an initial questionnaire to assess their 
baseline fitness and decide on the level of prehabilitation exercise video they should follow. 
Participants will be given information of when they should stop exercise (such as chest pain 
and excessive shortness of breath) and when to call for help.  
 
13.22 Oura Ring, Withings Watch, Corsano Wristband 
The Oura ring and Withings watch are commercially available non-medical vital sign 
monitor. The devices will not be used outside of their marketed function. Corsano wristband 
is an FDA approved medical bracelet. Participants will receive verbal instruction on how to 
use and charge their device. It does require connection to a smart phone. Full manufacturer 
instructions are included in all device boxes. There is a separate risk assessment form 
available. Information from the devices will not be used to guide clinical care. 
The risk of pressure injuries or dermatitis in the conscious participant is low, as conscious 
participants can notice and react to discomfort from the device prior to injury. Devices are 
removed on admission to hospital.  
 
14)    STATEMENT OF INDEMNITY  
The University has insurance available in respect of research involving human subjects that 
provides cover for legal liabilities arising from its actions or those of its staff or supervised 
students. The University also has insurance available that provides compensation for non-
negligent harm to research subjects occasioned in circumstances that are under the control 
of the University. 
 
15)    FUNDING and RESOURCES  
Funding has been provided by the charity Kidneys for Life to allow for the purchase of 
wearable devices, which are required to run this study.  
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 20 of 23 
OPERATe Research Protocol 
16)    PUBLICATION POLICY 
The outcomes of this study will be published, with anonymised data used, through internal 
education and research meetings at Manchester Royal Infirmary and the University of 
Manchester, external academic conference presentations, media publications and 
academic journal publications. Social media may be used to advertise the publications, such 
as journal articles. 
 
 
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 21 of 23 
OPERATe Research Protocol 
Appendix 1 - Scheme for Participants Contact 
Contact 1: Screening  
Participants will be screened by one of the research team members. This will either be over 
the phone or in person using the Screening proforma.  
Contact 2: Consent and set-up 
Patients will be formally consented to participate in the trial. They will complete baseline 
questionnaires and be set up with their wearable device. Participants will undergo a non-
invasive hand grip strength test. Participants will be instructed as to which video(s) to use 
at home for their prehabilitation programme, which they will start after 2 weeks of baseline 
data collection. Participants will be contacted by telephone to remind them of their 
prehabilitation start date.  
Contact 3:  Prehabilitation programme review 1 
Participants will be contacted approximately 2 weeks after starting their prehabilitation 
programme. This will discuss any difficulties they have experienced and confirm the plan 
for the video(s) to follow for the next 2 weeks of prehabilitation.  
Contact 4: Prehabilitation programme review 2 
Participants will be contacted approximately 4 weeks after starting their prehabilitation 
programme. This will discuss any difficulties they have experienced and confirm the plan 
for the video(s) to follow for the next 2 weeks of prehabilitation.  
Contact 5: Completion of prehabilitation programme 
On admission to hospital the participants will repeat the hand grip strength test and 
complete a questionnaire on how they feel the prehabilitation programme has gone. 
Wearable devices will be removed during their inpatient stay and reapplied on discharge 
for a further 6 weeks of monitoring. 
Contact 6: End of study 
Participants will be contacted at their 6 week follow up point after surgery, to complete the 
end questionnaire and return their wearable device and patient journal.  
 
 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 22 of 23 
OPERATe Research Protocol 
17)    REFERENCES 
1. 
Banugo P, Fcai B, Amoako D, Frca M. Prehabilitation. [cited 2023 Mar 14]; Available from: 
https://academic.oup.com/bjaed/article/17/12/401/4083340 
2. 
Nielsen PR, Andreasen J, Asmussen M, Tønnesen H. Costs and quality of life for 
prehabilitation and early rehabilitation after surgery of the lumbar spine. BMC Health Serv 
Res [Internet]. 2008 Oct 9 [cited 2023 Mar 14];8(1):1–7. Available from: 
https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-8-209 
3. 
Santa Mina D, Hilton WJ, Matthew AG, Awasthi R, Bousquet-Dion G, Alibhai SMH, et al. 
Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial. Surg 
Oncol [Internet]. 2018 Jun 1 [cited 2023 Mar 14];27(2):289–98. Available from: 
https://pubmed.ncbi.nlm.nih.gov/29937184/ 
4. 
Minnella EM, Awasthi R, Loiselle SE, Agnihotram R V., Ferri LE, Carli F. Effect of Exercise and 
Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A 
Randomized Clinical Trial. JAMA Surg [Internet]. 2018 Dec 1 [cited 2023 Mar 
14];153(12):1081–9. Available from: https://pubmed.ncbi.nlm.nih.gov/30193337/ 
5. 
Nakajima H, Yokoyama Y, Inoue T, Nagaya M, Mizuno Y, Kadono I, et al. Clinical Benefit of 
Preoperative Exercise and Nutritional Therapy for Patients Undergoing Hepato-Pancreato-
Biliary Surgeries for Malignancy. Ann Surg Oncol [Internet]. 2019 Jan 15 [cited 2023 Mar 
14];26(1):264–72. Available from: https://pubmed.ncbi.nlm.nih.gov/30367303/ 
6. 
Mohan R, Huey CWT, Junnarkar S, Low JK, Shelat VG. Prehabilitation in elderly patients 
scheduled for liver resection and protocol for Recovery Of Surgery in Elderly. Hepatoma 
Res. 2020 Mar 26;2020.  
7. 
Valkenet K, Van De Port IGL, Dronkers JJ, De Vries WR, Lindeman E, Backx FJG. The effects 
of preoperative exercise therapy on postoperative outcome: a systematic review. Clin 
Rehabil [Internet]. 2011 Feb [cited 2023 Mar 14];25(2):99–111. Available from: 
https://pubmed.ncbi.nlm.nih.gov/21059667/ 
8. 
Maring H, Haanstra A, Annema C. Evidence based interventions suitable for prehabilitation 
to improve physical functioning in kidney transplant candidates: a scoping review protocol.  
9. 
Wilson RJT, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is 
associated with all-cause mortality after major elective intra-abdominal surgery. Br J 
Anaesth [Internet]. 2010 [cited 2023 Mar 14];105(3):297–303. Available from: 
https://pubmed.ncbi.nlm.nih.gov/20573634/ 
10. 
Feldman LS, Zavorsky GS, Kim DJ, Scott S, Carli F, Charlebois P, et al. Randomized clinical 
trial of prehabilitation in colorectal surgery. Br J Surg Article in British Journal of Surgery 
[Internet]. 2010 [cited 2023 Mar 14]; Available from: www.bjs.co.uk 

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 23 of 23 
OPERATe Research Protocol 
11. 
Scheede-Bergdahl C, Minnella EM, Carli F. Multi-modal prehabilitation: addressing the why, 
when, what, how, who and where next? Anaesthesia. 2019 Jan 1;74:20–6.  
12. 
Artom M, Moss-Morris R, Caskey F, Chilcot J. Fatigue in advanced kidney disease. Kidney 
Int. 2014 Sep 1;86(3):497–505.  
13. 
Greenwood S, Lindup H, Taylor K, Koufaki P, Rush R, MacDougall I, et al. Evaluation of a 
pragmatic exercise rehabilitation programme in chronic kidney disease. Nephrol Dial 
Transplant. 2012;27(Suppl 3):iii126–34.  
14. 
Waller E, Sutton P, Rahman S, Allen J, Saxton J, Aziz O. Prehabilitation with wearables 
versus standard of care before major abdominal cancer surgery: a randomised controlled 
pilot study (trial registration: NCT04047524). Surg Endosc [Internet]. 2022 Feb 1 [cited 2023 
Mar 14];36(2):1008–17. Available from: https://link.springer.com/article/10.1007/s00464-
021-08365-6 
15. 
Zhu H, Moffa ZJ, Gui X, Carroll JM. Prehabilitation: Care Challenges and Technological 
Opportunities. Conference on Human Factors in Computing Systems - Proceedings 
[Internet]. 2020 Apr 21 [cited 2023 Mar 14]; Available from: 
https://dl.acm.org/doi/10.1145/3313831.3376594 
16. 
Moorthy K, Halliday LJ, Noor N, Peters CJ, Wynter-Blyth V, Urch CE. Feasibility of 
Implementation and the Impact of a Digital Prehabilitation Service in Patients Undergoing 
Treatment for Oesophago-Gastric Cancer. Current Oncology 2023, Vol 30, Pages 1673-1682 
[Internet]. 2023 Jan 30 [cited 2023 Mar 14];30(2):1673–82. Available from: 
https://www.mdpi.com/1718-7729/30/2/128/htm 
17. 
Levett DZH, Grimmett C. Psychological factors, prehabilitation and surgical outcomes: 
evidence and future directions. Anaesthesia. 2019 Jan 1;74:36–42.  
18. 
Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and 
Guiding Questions. 2009;  
19. 
Bhatia C, Kayser B. Preoperative high-intensity interval training is effective and safe in 
deconditioned patients with lung cancer: A randomized clinical trial. J Rehabil Med 
[Internet]. 2019 [cited 2023 Mar 14];51(9):712–8. Available from: 
https://pubmed.ncbi.nlm.nih.gov/31468059/ 
20. 
Morgan B, Hejdenberg J, Hinrichs-Krapels S, Armstrong D. Do feasibility studies contribute 
to, or avoid, waste in research? PLoS One [Internet]. 2018 Apr 1 [cited 2023 Mar 
14];13(4):e0195951. Available from: 
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0195951 
21. 
Ma X, Zhang Z, Peng M, Yao B, Jiang H, Ji X, et al. Face-to-Face Mentoring, Remotely 
Supervised Home Exercise Prehabilitation to Improve Physical Function in Patients Awaiting 
Kidney Transplantation: A Randomized Clinical Trial. Front Psychol. 2022 Jun 16;13.  

IRAS ID:316796 
Version: OPERATe_PROTOCOL_22_10_2024 v3.0 
 
Page 24 of 23 
OPERATe Research Protocol 
22. 
McAdams-DeMarco MA, Ying H, Van Pilsum Rasmussen S, Schrack J, Haugen CE, Chu NM, 
et al. Prehabilitation prior to kidney transplantation: Results from a pilot study. Clin 
Transplant. 2019 Jan 1;33(1).  
23. 
Hughes MJ, Hackney RJ, Lamb PJ, Wigmore SJ, Christopher Deans DA, Skipworth RJE. 
Prehabilitation Before Major Abdominal Surgery: A Systematic Review and Meta-analysis. 
World J Surg [Internet]. 2019 Jul 15 [cited 2023 Mar 14];43(7):1661–8. Available from: 
https://link.springer.com/article/10.1007/s00268-019-04950-y 
24. 
Wilson D, Jackson T, Sapey E, Lord JM. Frailty and sarcopenia: The potential role of an aged 
immune system. Ageing Res Rev. 2017 Jul 1;36:1–10.  
25. 
Ha YC, Hwang SC, Song SY, Lee CH, Park KS, Yoo J Il. Hand grip strength measurement in 
different epidemiologic studies using various methods for diagnosis of sarcopenia: a 
systematic review. Vol. 9, European Geriatric Medicine. Springer International Publishing; 
2018. p. 277–88.  
26. 
Bahat G, Tufan A, Tufan F, Kilic C, Akpinar TS, Kose M, et al. Cut-off points to identify 
sarcopenia according to European Working Group on Sarcopenia in Older People (EWGSOP) 
definition. Clinical Nutrition. 2016 Dec 1;35(6):1557–63.   
28. 
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the 
analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 
[Internet]. 2013 Sep 18 [cited 2023 Mar 15];13(1):1–8. Available from: 
https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-13-117