Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates
Recruiting · NCT06089473 · Interventional (participants receive a specific treatment) · Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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. individuals who will receive an organ from a living donor or are type A blood
- have pre-existing or newly identified significant cognitive impairment
- have pre-existing or newly identified cardiac, musculoskeletal, neuropathy or neurological condition that might affect their exercise performance or otherwise render rehabilitation participation unsafe
Where it is running
2 locations listed.
- Centre de recherche - Centre Hospitalier de l'Université de Montréal (CRCHUM) - Montreal, Quebec, Canada
- Research Institute - McGill University Health Centre (RI-MUHC) - Montreal, Quebec, Canada