Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates: a Pilot RCT

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Canada
Centre de recherche - Centre Hospitalier de l'Université de Montréal (CRCHUM)
RECRUITING
Montreal
Research Institute - McGill University Health Centre (RI-MUHC)
RECRUITING
Montreal
Contact Information
Primary
Tania Janaudis-Ferreira, PhD
tania.janaudis-ferreira@mcgill.ca
514-619-0871
Backup
Amanda Rizk, PhD
amanda.rizk@rimuhc.ca
514-885-0668
Time Frame
Start Date: 2024-11-02
Estimated Completion Date: 2027-02
Participants
Target number of participants: 30
Treatments
Other: Experimental: Pre-habilitation plus usual outpatient care
An intervention including exercise and education.
Other: No Intervention: Usual outpatient care
The control group will receive usual outpatient care provided to kidney transplant candidates. All participants in the control group will receive educational resources received by intervention group participants at trial completion.
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: The Kidney Foundation of Canada

This content was sourced from clinicaltrials.gov