Outcomes of a Pre-operative Exercise Regimen for Patients Undergoing Hand-assisted Liver Donor Nephrectomy and Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Manchester
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number days exercise regimen performed and wearable device worn
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Entire cohort
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).
Intervention: Exercise programme (Other)
Entire cohort
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).
Intervention: Wearable smart device (Device)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Gareth Kitchen
Chief Investigator
University of Manchester