Clinical trial NCT06089473: Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates
Official title: Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates: a Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Disease, End-Stage
Frailty
Transplant;Failure,Kidney
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: The Kidney Foundation of Canada
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with 2 arms
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of screened patients who meet eligibility criteria
timeFrame: at 12 months
measure: Proportion of eligible patients who consent to randomization
timeFrame: at 12 months
measure: Proportion of patients who adhere to the interventions
timeFrame: at 12 months
measure: Rate of follow-up completion as assessed by number of randomized patients completing assessments pre- and post-induction phase.
timeFrame: at 12 months
Secondary outcomes:
measure: Rate of change in frailty status as assessed by Fried's phenotype method
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Rate of change in bodyweight obtained from electronic medical chart (contributing to frailty status score for Fried's phenotype method).
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Rate of change in handgrip strength as assessed by hand dynamometer (contributing to frailty status score for Fried's phenotype method).
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Incidence of exhaustion as assessed by Center for Epidemiological Studies Depression (CES-D) (contributing to frailty status score for Fried's phenotype method).
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: 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).
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Rate of change in low physical activity status as assessed by the Rapid Assessment of Physical Activity (RAPA) questionnaire (contributing to frailty status score for Fried's phenotype method).
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Rate of change in lower-extremity function will be assessed using the short physical performance battery (SPPB).
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Rate of change in functional exercise capacity as assessed by the 6-minute walk test
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Rate of change in Health Related Quality of Life scores as assessed by the Kidney Disease Quality of Life Short Form Instrument (KDQOL-SF)
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant
measure: Changes in nutrition status as assessed by Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: For those who receive a transplant within study period: baseline and 3-months post-transplant. For those who do not receive a transplant during study period: baseline and 8-months.
measure: Rate of change in body composition as measured by Bioelectrical Impedance
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant.
measure: Concentration of serum phosphorus (mmol/L)
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant.
measure: Concentration of serum potassium (mmol/L)
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant.
measure: Percentage of serum A1C
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant.
measure: Incidence of anxiety as assessed by Generalized Anxiety Disorder Seven-Item Scale (GAD-7)
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant.
measure: Incidence of depression as assessed by the Patient Health Questionnaire (PHQ-8)
timeFrame: At baseline, post-induction phase (12 weeks), at 6 months, at 8 months, at 3-month post-transplant.
measure: Level of safety as assessed by number/severity of recorded adverse events related to the intervention
timeFrame: from recruitment to end of intervention
measure: Trends identified in post-transplant recovery trajectory as sourced from electronic medical chart information
timeFrame: at 3-month post-transplant
measure: Level of acceptability of the intervention as assessed by quantitative semantic differential scale
timeFrame: Post-induction phase (at 12-weeks), and at 8-months
measure: Level of acceptability of the intervention as assessed by qualitative author-generated questionnaire
timeFrame: at 8-months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre de recherche - Centre Hospitalier de l'Université de Montréal (CRCHUM)
state: Quebec
city: Montreal
country: Canada
facility: Research Institute - McGill University Health Centre (RI-MUHC)
state: Quebec
Study officials:
affiliation: Research Institute of McGill University Health Centre (RI-MUHC)
name: Tania Janaudis-Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
References: