Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
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
This trial does not accept healthy volunteersQualifiers
Aged 18 years and over
Live kidney donor or transplant recipient
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Exercise programme
Other intervention6 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
DeviceParticipants 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,
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Entire cohortExperimental treatment 2 interventions
Trial outcomes
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
Time frame
From enrollment to the end of the study at 14 weeks totalSecondary outcomes
1
Number of participants with post operative complications
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.
Time frame
From enrollment to the end of the study at 14 weeks total - complications recorded at 6 week post op follow up2
REM Sleep pattern analysis
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.
Time frame
From enrollment to the end of the study at 14 weeks total when data collection ends3
Resting heart rate and heart rate variability
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)
Time frame
From enrollment to the end of the study at 14 weeks total when data collection endsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manchester
Lead sponsor
Manchester University NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: