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.
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)
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
Parallel
Intervention Group: Exercise and education.
Other intervention* 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
Other interventionUsual Care for kidney transplant candidates, which may include medical visits, nutrition, and psychological support.
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.
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.
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.
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.
Rate of change in frailty status as assessed by Fried's phenotype method
Frailty status as measured at the timepoints described below will use the Fried's phenotype method, identified by 3 or more of the following criteria. (please see each component outlined as its own outcome measure). 1. Weight loss 2. Weakness will be assessed using the handgrip strength test ith cut-off values provided by the Frailty index to determine weakness. 3. Exhaustion: 4. Slow gait: 5. Low physical activity: Scoring for the Fried Phenotype: Each indicator can have 0 or 1 as a score, resulting in a total of maximum 5 points, where 0 is being robust, 1-2 pre-frail, 3-4 frail and 5 very frail.
Rate of change in bodyweight obtained from electronic medical chart (contributing to frailty status score for Fried's phenotype method).
Weight loss (of \> 10 lbs over 6 months): obtained from the patient or chart.
Rate of change in handgrip strength as assessed by hand dynamometer (contributing to frailty status score for Fried's phenotype method).
Weakness will be assessed using the handgrip strength test (Jamar hydraulic hand Dynamometer). Patients will do six measurements (three times for each hand, with a rest break of 30 seconds between each). The highest measurement will be compared with cut-off values provided by the Frailty index to determine weakness.
Incidence of exhaustion as assessed by Center for Epidemiological Studies Depression (CES-D) (contributing to frailty status score for Fried's phenotype method).
Exhaustion will be measured by self-reported information based on two questions relating to feeling unusually tired and/or weak, taken from the Center for Epidemiological Studies Depression (CES-D) scale.
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
The Kidney Foundation of Canada
Collaborator
