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

NCT06858098 | Not Yet Recruiting

• 1 other identifier: 316796
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplant; Kidney Transplant Donor; Kidney Transplant Recipient

Keywords

live kidney transplant; prehabilitation; wearable devices

Outcome Measures

Primary Outcomes (1)

• Number days exercise regimen performed and wearable device worn

  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

  From enrollment to the end of the study at 14 weeks total

Secondary Outcomes (3)

• 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

• REM Sleep pattern analysis

  From enrollment to the end of the study at 14 weeks total when data collection ends

• Resting heart rate and heart rate variability

  From enrollment to the end of the study at 14 weeks total when data collection ends

Study Arms (1)

Entire cohort

EXPERIMENTAL

All participants (both transplant donor and recipients) will be assigned a 6 week graded pre operative outpatient exercise regimen (prehabilitation) delivered by video instruction. Participants will also be monitored 24/7 by a wearable smart device for a total 14 week period (2 week baseline data collection, 6 weeks during prehabilitation and 6 weeks post op).

Other: Exercise programme; Device: Wearable smart device

Interventions

Exercise programme OTHER

6 week pre-operative graded prehabilitation programme, delivered by video and performed by participant up to 4 times a week at home or in a gym setting

Entire cohort

Wearable smart device DEVICE

Participants will wear a wearable smart device (wrist or ring worn) for a period for 14 weeks; 2 weeks prior to prehabilitation, 6 weeks during pre-operative prehabilitation and 6 weeks post operative monitoring,

Entire cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Study Officials

• Gareth Kitchen

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Hussein Khambalia

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gareth Kitchen

CONTACT

+447977280019; gareth.kitchen@manchester.ac.uk

Sophie Collinson

CONTACT

+447766827099; sophie.collinson1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 5, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)