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

McGill University

Status: Enrolling

Conditions: Kidney Disease, End-Stage; Frailty; Transplant;Failure,Kidney

Treatments: Other: Intervention Group: Exercise and education.; Other: Usual Care Only

Study type: Interventional

Funder types: Other

Identifiers

NCT06089473

2023-10799

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Experimental: Pre-habilitation plus usual outpatient care

Other group

Description:

An intervention including exercise and education.

Treatment:

Other: Intervention Group: Exercise and education.

No Intervention: Usual outpatient care

Other group

Description:

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.

Treatment:

Other: Usual Care Only