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Not yet recruiting NCT06858098

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

No phase Interventional Kidney Transplant Kidney Transplant Donor Kidney Transplant Recipient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise programme, Wearable smart device.
Who it may be relevant to
Registry conditions: Kidney Transplant, Kidney Transplant Donor, Kidney Transplant Recipient. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Other Exercise programme
    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
  • Device Wearable smart 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 outcome measures

  • Number days exercise regimen performed and wearable device worn [Time frame: From enrollment to the end of the study at 14 weeks total]
Secondary outcome measures (3)
  • 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]
  • REM Sleep pattern analysis [Time frame: From enrollment to the end of the study at 14 weeks total when data collection ends]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • Manchester Royal Infirmary — Manchester

Identifiers

NCT: NCT06858098 · 316796

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗