Clinical trial NCT06858098: Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients
Official title: Outcomes of a Pre-operative Exercise Regimen for Patients Undergoing Hand-assisted Liver Donor Nephrectomy and Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplant
Kidney Transplant Donor
Kidney Transplant Recipient
Keywords: live kidney transplant
prehabilitation
wearable devices
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2025-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Number days exercise regimen performed and wearable device worn
timeFrame: From enrollment to the end of the study at 14 weeks total
Secondary outcomes:
measure: Number of participants with post operative complications
timeFrame: From enrollment to the end of the study at 14 weeks total - complications recorded at 6 week post op follow up
measure: REM Sleep pattern analysis
timeFrame: From enrollment to the end of the study at 14 weeks total when data collection ends
measure: Resting heart rate and heart rate variability
timeFrame: From enrollment to the end of the study at 14 weeks total when data collection ends
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: University of Manchester
name: Gareth Kitchen
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester University NHS Foundation Trust
name: Hussein Khambalia
role: PRINCIPAL_INVESTIGATOR
References: