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

University of Manchester

Status: Not yet enrolling

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

Treatments: Other: Exercise programme; Device: Wearable smart device

Study type: Interventional

Funder types: Other

Identifiers

NCT06858098

316796

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Entire cohort

Experimental group

Description:

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).

Treatment:

Device: Wearable smart device

Other: Exercise programme