Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates
Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates: a Pilot RCT
McGill University Health Centre/Research Institute of the McGill University Health Centre
30 participants
Nov 2, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria9
- 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
Interventions
* Exercise Intervention: 12-weeks of supervised, individualized virtual exercise sessions, delivered by an accredited kinesiologist. Independent unsupervised sessions start at week 5. After 12 weeks, a 5-month maintenance phase is followed, continuing to exercise three times weekly for 30 minutes per session. * Education: Prior to each zoom session with the kinesiologist (starting on week 2), participants will watch short educational videos. Additionally, participants will be provided a document (PDF) of evidence-based strategies to help cope with stress.
Usual Care for kidney transplant candidates, which may include medical visits, nutrition, and psychological support.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06089473