Actively Recruiting
Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates: a Pilot Randomized Controlled Trial
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-12-03
30
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
T
The Kidney Foundation of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates the feasibility of a virtual home-based pre-habilitation program for adults with end-stage kidney disease awaiting kidney transplant. The study aims to evaluate how many candidates meet eligibility, consent to participate, adhere to the program, complete follow-up, and their acceptance of the intervention. The trial compares this virtual pre-habilitation plus usual care against usual outpatient care alone in kidney transplant candidates. Participants in the intervention group receive a 12-week supervised virtual exercise program led by a kinesiologist, including individualized sessions and independent exercises starting week 5. After 12 weeks, a 5-month maintenance phase continues with home exercises three times per week. Educational videos and stress coping materials are also provided. The control group receives usual outpatient care, including medical visits, nutrition, and psychological support, with educational resources shared after the study. Participants undergo nutrition screening and complete questionnaires on anxiety and depression, with abnormal scores reported to their transplant team. Assessments include physical function, frailty measures, quality of life, nutrition status, and biochemical tests at baseline, during follow-up, and post-transplant if applicable. The study tracks adherence, follow-up rates, and safety over up to 8 months or until transplantation. The trial will help plan a larger study on pre-habilitation effectiveness in this population.
CONDITIONS
Brief Title
Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with end-stage kidney disease (ESKD)
- Classified as pre-frail, frail, or very frail using Fried's frailty phenotype
- Accepted or in process of acceptance on the kidney transplant waiting list at specified hospitals
- English or French speaking
- Able to connect to online videoconferencing independently or with help
- Patients without internet access will be provided a tablet with internet during the study
You will not qualify if you...
- Classified as robust (0 points) on Fried's frailty phenotype
- Currently participating in a structured exercise program
- Waiting for kidney-pancreas or kidney-liver transplant
- Hospitalized during eligibility assessment
- Highly sensitized with cPRA >95% and on a special exchange program
- Expected to receive transplant before end of 12-week intervention
- Significant cognitive impairment
- Cardiac, musculoskeletal, neuropathy, or neurological conditions affecting safe exercise participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 8 months or until transplantation
Participants in the intervention group engage in a 12-week virtual home-based supervised exercise program with education, followed by a 5-month maintenance phase of independent home exercises. Participants in the control group receive usual outpatient care. Educational resources are provided to all participants at trial completion.
Regular virtual exercise sessions during the first 12 weeks with educational videos and ongoing home exercise maintenance thereafter
Duration - Up to 11 months including post-transplant assessments
Participants complete assessments at multiple timepoints including baseline, post-induction (12 weeks), 6 months, 8 months, and 3 months post-transplant if applicable. Assessments include physical function, nutrition, psychological status, and quality of life.
Multiple assessment visits including in-person and virtual assessments at specified intervals
Trial Site Locations
Total: 2 locations
1
Centre de recherche - Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
2
Research Institute - McGill University Health Centre (RI-MUHC)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
T
Tania Janaudis-Ferreira, PhD
A
Amanda Rizk, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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