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

NCT06089473 | Recruiting DMC

• 1 other identifier: 2023-10799
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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; Transplant;Failure,Kidney; Frailty

Outcome Measures

Primary Outcomes (4)

• Proportion of screened patients who meet eligibility criteria

  Data generated from this pilot RCT will inform the feasibility of a full-scale RCT by testing the study procedures; therefore, no inferential statistical analyses will be performed to compare groups. Socio-demographic, anthropometric and clinical data will be described using means and standard deviation or median and interquartile range for continuous variables and number and percentage for categorical variables. The variables will be presented at baseline, end of the 12 weeks (induction phase), at 6 months (during maintenance phase), at 8 months (end of maintenance phase) at 3-month post-transplant. Descriptive statistics (frequencies and percentages) will be used to report the feasibility and safety outcomes.

  at 12 months

• Proportion of eligible patients who consent to randomization

  Data generated from this pilot RCT will inform the feasibility of a full-scale RCT by testing the study procedures; therefore, no inferential statistical analyses will be performed to compare groups. Socio-demographic, anthropometric and clinical data will be described using means and standard deviation or median and interquartile range for continuous variables and number and percentage for categorical variables. The variables will be presented at baseline, end of the 12 weeks (induction phase), at 6 months (during maintenance phase), at 8 months (end of maintenance phase) at 3-month post-transplant. Descriptive statistics (frequencies and percentages) will be used to report the feasibility and safety outcomes.

  at 12 months

• Proportion of patients who adhere to the interventions

  Data generated from this pilot RCT will inform the feasibility of a full-scale RCT by testing the study procedures; therefore, no inferential statistical analyses will be performed to compare groups. Socio-demographic, anthropometric and clinical data will be described using means and standard deviation or median and interquartile range for continuous variables and number and percentage for categorical variables. The variables will be presented at baseline, end of the 12 weeks (induction phase), at 6 months (during maintenance phase), at 8 months (end of maintenance phase) at 3-month post-transplant. Descriptive statistics (frequencies and percentages) will be used to report the feasibility and safety outcomes.

  at 12 months

• Rate of follow-up completion as assessed by number of randomized patients completing assessments pre- and post-induction phase.

  Data generated from this pilot RCT will inform the feasibility of a full-scale RCT by testing the study procedures; therefore, no inferential statistical analyses will be performed to compare groups. Socio-demographic, anthropometric and clinical data will be described using means and standard deviation or median and interquartile range for continuous variables and number and percentage for categorical variables. The variables will be presented at baseline, end of the 12 weeks (induction phase), at 6 months (during maintenance phase), at 8 months (end of maintenance phase) at 3-month post-transplant. Descriptive statistics (frequencies and percentages) will be used to report the feasibility and safety outcomes. Completeness to follow-up will be compared between trial arms.

  at 12 months

Secondary Outcomes (20)

• Rate of change in frailty status as assessed by Fried's phenotype method

  At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant

• Rate of change in bodyweight obtained from electronic medical chart (contributing to frailty status score for Fried's phenotype method).

  At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant

• Rate of change in handgrip strength as assessed by hand dynamometer (contributing to frailty status score for Fried's phenotype method).

  At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant

• Incidence of exhaustion as assessed by Center for Epidemiological Studies Depression (CES-D) (contributing to frailty status score for Fried's phenotype method).

  At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant

• Rate of change in gait speed as assessed by the 4-metre gait speed test (contributing to frailty status score for Fried's phenotype method).

  At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant

Study Arms (2)

Experimental: Pre-habilitation plus usual outpatient care

OTHER

An intervention including exercise and education.

Other: Intervention Group: Exercise and education.

No Intervention: Usual outpatient care

OTHER

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.

Other: Usual Care Only

Interventions

Intervention Group: Exercise and education. OTHER

* 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.

Experimental: Pre-habilitation plus usual outpatient care

Usual Care Only OTHER

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

No Intervention: Usual outpatient care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• The Kidney Foundation of Canada: collaborator

Study Sites (2)

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

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

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

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Frailty

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Tania Janaudis-Ferreira, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania Janaudis-Ferreira, PhD

CONTACT

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

Amanda Rizk, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes will be assessed without knowledge of group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist, Translational Research in Respiratory Diseases Program

Model Details: RCT with 2 arms

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 18, 2023
• Study Start: November 2, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 12 months from the last visit of the last participant.
• Access Criteria: Access to anonymized IPD can be requested by researchers.

Locations

CA (2)