Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients

Not Applicable

Not yet recruiting

• Conditions: Kidney Transplant; Kidney Transplant Donor; Kidney Transplant Recipient

• Registration Number: NCT06858098
• Lead Sponsor: University of Manchester

Brief Summary

The goal of this clinical trial is to learn if a pre-operative outpatient exercise programme, monitored by a smart wearable device is acceptable to live kidney donor and recipient transplant patients. It will also look at the impact of prehabilitation on post operative outcomes. The main questions it aims to answer are:

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?

Are transplant outcomes improved by prehabilitation regimens delivered by video instruction?

Are there discernible perioperative digital signatures provided by the wearable that link to surgical outcomes?

Is the quality of perioperative sleep linked to surgical outcomes?

Participants will:

Wear a wrist or ring worn wearable device for a total of 14 weeks (2 week baseline, 6 week pre op and 6 week post op) Engage in a 6 week pre operative exercise programme at home/gym Keep a diary and answer surveys on their experience of the exercise regimen and wearable device

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-26
• Status Verified: 2025-03
• Study First Posted: 2025-03-05
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Start: 2025-05-01
• Primary Completion: 2026-05-28
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged 18 years and over
• Live kidney donor or transplant recipient

Exclusion Criteria

• Deceased donor transplant recipient
• Patient unable to wear or tolerate wearable device
• Unstable angina, recent myocardial infarction, recent cerebrovascular accident or new arrythmia
• Patient declines or is unable to participate in the exercise programme
• Lacks capacity to give informed consent to participate in trial
• Non-English speaking
• No access to a smart device to download application

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number days exercise regimen performed and wearable device worn	From enrollment to the end of the study at 14 weeks total	Acceptability of a prehabiltation programme and wearable device. Is a pre-operative exercise regimen, monitored by a wearable smart device acceptable to live kidney donor and recipient transplant patients? Qualitative data collected through patient surveys and journals. Quantitative measures = number of days exercise performed \& number of days wearable device worn

Secondary Outcome Measures

Name	Time	Method
Number of participants with post operative complications	From enrollment to the end of the study at 14 weeks total - complications recorded at 6 week post op follow up	To assess if prehabilitation programmes have a positive effect on surgical outcomes, quantitative data on the rate and type of post operative complications will be recorded at the standard 6 week post operative patient follow up.
REM Sleep pattern analysis	From enrollment to the end of the study at 14 weeks total when data collection ends	To assess if there is a link between perioperative sleep patterns and post surgical complications, retrospective analysis of changes in REM vs Non-REM sleep patterns over the 14 week period will be compared to the incidence of post operative complications. REM vs. non-REM data is measured by the wearable device.
Resting heart rate and heart rate variability	From enrollment to the end of the study at 14 weeks total when data collection ends	Are there discernible perioperative digital signatures (vital signs) recorded by the wearable device that are linked to post-operative outcomes? Retrospective analysis of changes in resting heart rate and heart rate variability, both associated with physiological fitness, will be performed and compared to the incidence of post surgical complications in individual participants (outcome 2)

Trial Locations

Locations (1)

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom