Recruiting

Pre-habilitation

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT06089473

Conditions

Kidney Disease, End-Stage

Frailty

Transplant;Failure,Kidney

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention Group: Exercise and education.

Usual Care Only

Study Details

Brief 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.

Conditions

Kidney Disease, End-Stage

Frailty

Transplant;Failure,Kidney

Study ID

NCT06089473

Start date

Nov 2, 2024

Status verified date

Nov, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

Intervention Group: Exercise and education.

  • 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 Only

Usual Care for kidney transplant candidates, which may include medical visits, nutrition, and psychological support.

Primary outcome measure

  • Proportion of screened patients who meet eligibility criteria [ Time Frame: at 12 months ]
  • Proportion of eligible patients who consent to randomization [ Time Frame: at 12 months ]
  • Proportion of patients who adhere to the interventions [ Time Frame: at 12 months ]
  • Rate of follow-up completion as assessed by number of randomized patients completing assessments pre- and post-induction phase. [ Time Frame: at 12 months ]

Central Contacts and Locations

Central contacts

Tania Janaudis-Ferreira, PhD

514-619-0871tania.janaudis-ferreira@mcgill.ca

Amanda Rizk, PhD

514-885-0668amanda.rizk@rimuhc.ca

Locations

Centre de recherche - Centre Hospitalier de l'Université de Montréal (CRCHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Noemi Tousignant

514-890-8000noemi.tousignant.chum@ssss.gouv.qc.ca

Principal Investigator:

Marie-Chantal Fortin, MD, PhD

Research Institute - McGill University Health Centre (RI-MUHC)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Tania Janaudis-Ferreira, PhD

514-619-0871tania.janaudis-ferreira@mcgill.ca

Amanda Rizk, PhD

514-885-0668amanda.rizk@rimuhc.ca

Principal Investigator:

Tania Janaudis-Ferreira, PhD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-12-03.