Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates
Canada30 participantsStarted 2024-11-02
Plain-language summary
The goal of this RCT is to address the feasibility of conducting a 12-week virtual pre-habilitation intervention, which includes exercise and education, in kidney transplant candidates. The intervention also includes a 5-month maintenance phase with independent home exercises (maximum of 8 months of intervention/ended early if the participant undergoes a kidney transplant). The main questions it aims to answer are:
* estimate the proportion of screened patients who meet eligibility criteria
* estimate the proportion of eligible patients who consent to randomization
* estimate the proportion of patients who adhere to the interventions
* estimate follow-up completion rates
* inform the calculation of sample size requirements for a full-scale RCT
* assess the acceptability of the intervention by the participants.
Participants in the control group will receive usual outpatient care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* consecutive individuals with end stage kidney disease (ESKD) (aged ≥18 years), classified as pre-frail (1-2 points), frail (3-4 points) or very frail (5 points) on the Fried's frailty phenotype and who are accepted or in the process of being accepted to enter in the deceased or living donor KT waiting list of the McGill University Health Centre (MUHC), Centre Hospitalier de l'Université de Montreal (CHUM) or University of Alberta Hospital (UAH) for first-time transplantation or re-transplantation
* English or French speakers
* is technologically capable of connecting (either independently or through household members/next-of-kin) with an online videoconferencing platform through an e-mail invitation (Patients who do not have access to internet will borrow a tablet with internet for the period of the study)
Exclusion Criteria:
* Individuals who:
* are classified as robust (0 points) on their Fried's frailty phenotype score
* are participating in a structured exercise program (hospital-based or home-based or another trial)
* are waiting for kidney-pancreas or kidney-liver transplant as those have much longer waiting time
* are hospitalized for any reason during the assessment for eligibility
* have a cPRA (calculated panel reactive antibodies) \>95% and are on the highly sensitized exchange program and expected to have a prolonged waiting times on the waiting list
* are expected to have a transplant before the end of the 12 week-intervention (e.g. indiv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of screened patients who meet eligibility criteria
Timeframe: at 12 months
2
Proportion of eligible patients who consent to randomization
Timeframe: at 12 months
3
Proportion of patients who adhere to the interventions
Timeframe: at 12 months
4
Rate of follow-up completion as assessed by number of randomized patients completing assessments pre- and post-induction phase.
Timeframe: at 12 months
Trial details
NCT IDNCT06089473
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre