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NCT Number: NCT06858098

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

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

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Key information

Conditions

Kidney Transplant Kidney Transplant Donor Kidney Transplant Recipient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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,

Primary outcomes

  1. Number days exercise regimen performed and wearable device worn

    Time frame: 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 outcomes

  1. Number of participants with post operative complications

    Time frame: 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.

  2. REM Sleep pattern analysis

    Time frame: 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.

  3. Resting heart rate and heart rate variability

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Gareth Kitchen

CONTACT

[email protected]

+447977280019

Sophie Collinson

CONTACT

[email protected]

+447766827099

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Manchester University NHS Foundation Trust

Registry information

Official study title

Outcomes of a Pre-operative Exercise Regimen for Patients Undergoing Hand-assisted Liver Donor Nephrectomy and Transplantation

Acronym: OPERATe

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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