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

Frailty Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

The goal of this RCT is to address the feasibility to conduct a multimodal physical pre-habilitation intervention in kidney transplant candidates. 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. The 12-week virtual home-based supervised exercise program and 5-month maintenance phase with independent home exercises will also include nutrition, education, and psychological support. Participants in the control group will receive usual outpatient care.

Clinical Trial Description

While waiting for kidney transplant, candidates face many challenges related to their physical and psychological 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 nutritional counselling and psychological support 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). This study's pre-habilitation intervention consists of three components: exercise, nutrition, and psychological support. 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). The nutrition intervention will include a comprehensive nutrition assessment by a dietitian that includes malnutrition assessment, weight and body composition and dietary assessment. Participants will then have an in-person visit with the nutritionist and be encouraged to meet their estimated nutrients needs according to chronic kidney disease stage, presence of diabetes and dialysis treatment. The psychological intervention will include an initial in-person consultation with a graduate student supervised by a psychologist to identify participant's needs. If there are issues with depression and anxiety, participants will be referred to a web-based resource with evidence-based strategies and resources to cope with depression and anxiety, including cognitive reframing and relaxation techniques. Participants who score 'abnormal' on the assessment tools will be referred to a psychiatrist if this has not been done by the transplant team yet. Patients in the control group will receive usual outpatient care. ;

Related Conditions & MeSH terms

• Frailty
• Kidney Disease, End-Stage
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Transplant;Failure,Kidney

• NCT number: NCT06089473
• Study type: Interventional
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Tania Janaudis-Ferreira, PhD
• Phone: 514-619-0871
• Email: tania.janaudis-ferreira@mcgill.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: November 1, 2024