Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates

Last updated: November 25, 2025
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Disease

Nephropathy

Kidney Failure

Treatment

Intervention Group: Exercise and education.

Intervention Group: Exercise, Nutritional, and Psychological Support

Usual Care Only

Clinical Study ID

NCT06089473
2023-10799
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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) onthe Fried's frailty phenotype and who are accepted or in the process of beingaccepted to enter in the deceased or living donor KT waiting list of the McGillUniversity Health Centre (MUHC), Centre Hospitalier de l'Université de Montreal (CHUM) or University of Alberta Hospital (UAH) for first-time transplantation orre-transplantation

  • English or French speakers

  • is technologically capable of connecting (either independently or through householdmembers/next-of-kin) with an online videoconferencing platform through an e-mailinvitation (Patients who do not have access to internet will borrow a tablet withinternet for the period of the study)

Exclusion

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 oranother trial)

  • are waiting for kidney-pancreas or kidney-liver transplant as those have much longerwaiting time

  • are hospitalized for any reason during the assessment for eligibility

  • have a cPRA (calculated panel reactive antibodies) >95% and are on the highlysensitized exchange program and expected to have a prolonged waiting times on thewaiting 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 orneurological condition that might affect their exercise performance or otherwiserender rehabilitation participation unsafe

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Intervention Group: Exercise and education.
Phase:
Study Start date:
November 02, 2024
Estimated Completion Date:
February 28, 2027

Study Description

While waiting for kidney transplant, candidates face many challenges related to their physical health. These physical impairments are strongly associated with pre- and post-transplant mortality and morbidity. Pre-habilitation is the process of enhancing patient functional capacity prior to surgery with the objective of improving tolerance for the stressor. In the context of this protocol, pre-habilitation is referring to an exercise-based program with education prior to transplant. Pre-habilitation has been shown to contribute to a reduction of postoperative recovery time and quicker return to functional ability after thoracic and abdominal surgery. There is, however, limited evidence for the effects of pre-habilitation in kidney transplant candidates.

The investigators are following up previous work conducted with a very small (n=8) pilot pre-post study on pre-habilitation (MUHC REB number = 2020-5951) specifically with kidney transplant candidates. The results were encouraging.

The current multicenter pilot randomized controlled trial (RCT) will address the following research question: is it feasible to conduct a full-scale multicenter RCT to assess the comparative effectiveness of a virtual home-based pre-habilitation versus usual care for kidney transplant candidates? The investigators' specific objectives are to: (1) estimate the proportion of screened patients who meet eligibility criteria, (2) estimate the proportion of eligible patients who consent to randomization, (3) estimate the proportion of patients who adhere to the interventions, (4) estimate follow-up completion rates, (5) inform the calculation of sample size requirements for a full-scale RCT and, (6) assess the acceptability of the intervention by the participants. The assessor-blind pilot RCT will be conducted in three hospitals in Canada: MUHC, CHUM and University of Alberta Hospital. Eligible subjects will be randomized 1:1 to receive either i) virtual home-based multimodal pre-habilitation plus usual outpatient care, or ii) usual outpatient care. Participants will be drawn from the transplant clinics at the 3 sites, and the investigators aim to recruit 30 participants (22 of which will be recruited from MUHC over 9 months).

While some of the assessment appointments will be in person, the intervention is virtual so as not to burden the participants with extra hospital visits. The exercise portion of the study will include a 12-week virtual home-based supervised exercise program and a 5-month maintenance phase with independent home exercises (maximum of 8 months of intervention/ended early if the participant undergoes transplantation). Participants in the intervention group will also watch short educational videos about their kidney, assessment and waitlist, surgery and recovery, medication, and their new life after transplantation. Additionally, participants will be provided a document (PDF) of evidence-based strategies to help cope with stress.

Patients in the control group will receive usual outpatient care. All participants in the control group will receive educational resources received by intervention group participants at trial completion.

All participants will undergo a nutrition screening and will complete questionnaires regarding anxiety and depression. The corresponding transplant team will be notified should participants score 'abnormal' on these assessment tools. Additionally, all study participants will be asked questions regarding the following: whether they have had previous nutritional counselling or received any nutritional interventions, whether they have nutritional concerns/needs, whether they face any challenges in maintaining a balanced diet, whether they have had previous psychological counseling as part of the transplant assessment. This information will be collected as part of a needs assessment to inform inclusion of a nutritional and psychological interventions in subsequent trials.

Connect with a study center

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

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

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

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

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

    Montreal 6077243, Quebec 6115047 H2X 0A9
    Canada

    Active - Recruiting

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

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

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