Clinical trial NCT06367244: Transplant Wellness Program
Official title: Exercise and Wellness Behaviour Change for Solid Organ Transplant: A Hybrid Effectiveness-Implementation Trial of the Transplant Wellness Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transplantation
Keywords: Organ transplantation
Exercise
Prehabilitation
Health promotion
Behavior change
Rehabilitation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The TWP is a parallel study design with two arms. Participants are assigned to either the kidney or liver arm depending on the organ transplant they are listed or in evaluation for. Each arm will have a pre- or post- transplant group. Participants will be assigned to group depending on length of time between study enrollment and transplant surgery. Those with more than 12-weeks until surgery will complete the TWP pre-transplant and those with less than 12-weeks will complete the TWP post-transplant.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of overall health. Prehabilitation, or using rehabilitation in the period before surgery, can improve the pre, during, and post operative experience for the patient. Although exercise as prehabilitation has been well established in organ transplant, the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term. Supporting wellness behaviour change, such as exercise, stress reduction, and sleep, is associated with improved quality of life (QoL), mood, and improvements in well-being. Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes. The Transplant Wellness Program (TWP) is an exercise behaviour change program that includes additional wellness components such as nutrition, stress reduction, and sleep programs to support overall health and QoL of transplant patients. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QoL. The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant, depending on length of time from study enrollment to transplant surgery. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services use. Collected outcomes will include program reach, effectiveness measures such as changes in physical fitness, adoption by healthcare practitioners, implementation of the program, and maintenance. In addition, will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes, such as the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization.

Detailed description: Background and Rationale:

Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of holistic health. Prehabilitation, or using rehabilitation in the period before surgery, can help to optimize the surgical candidate and can improve the pre, peri and post operative experience for the patient. Although exercise as prehabilitation has been well established in solid organ transplant, the investigators believe a multiphasic approach will help to better serve patients and establish further health behavior change to support patient wellness in the long-term. Supporting wellness behaviour change, including using tenets from health coaching and patient-directed motivational counselling is associated with improved QOL, mood, and lowered perceived stress, as well as improvements in functional well-being. Incorporating behaviour change support in a multiphasic exercise prehabilitation program will support transplant patients in making positive lifestyle behaviour changes. Wellness programs need to be personalized and include behaviour change support to maintain motivation, provide feedback, and modify the program content as needed.

Research Question and Objectives: The Transplant Wellness Program (TWP) will target lifestyle behaviour change to enhance wellness, with a focus on improving exercise behaviour change. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QOL. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services utilization. In addition, the investigators believe the TWP will result in the reduction of several health care utilization outcomes, including the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization. Finally, the TWP will also work in conjunction with additional resources across wellness, including nutrition services, stress reduction, and sleep programs, to support an integration of lifestyle modifiable behaviours that support enhanced well-being and quality of life.

Methods: The transplant wellness program (TWP) is intended to enhance wellness across the transplant trajectory. Introducing exercise and wellness behaviour change to support physical and psychosocial well-being before and after transplant surgery, the TWP will work closely with participants to tailor programming to meet their needs. The TWP specifically includes the Exercise Intervention (EI), which is a 12-week exercise program. EI is delivered either pre-transplant (EI-Pre-Transplant) or after transplant (EI-Post-Transplant) if patients are unable to participate before transplant. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The exercise intervention will be multiphasic (pre-transplant and post-transplant) and include wellness behavior change support. Implementation outcomes will be evaluated using the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework.

To gain a better understanding of program implementation and to improve the quality of the program, participants will be requested to share their feedback upon completion of the exercise intervention through participant experience surveys and semi-structured interviews. Effectiveness outcomes include functional fitness outcomes (frailty and musculoskeletal function measures) and patient-reported outcomes (PROs). The PROs include QOL (using generic and disease specific measures), physical activity levels, sleep habits, nutrition, and mental health (anxiety and depression). Health economic evaluations will be performed to determine the cost-utility of implementing transplant wellness into the care pathway. Chart reviews will be done to collect information regarding outpatient and inpatient health care encounters, medication use, emergency visits, hospital admissions, length of hospital stays, intensive care unit admissions (length of stay and days intubated), patient and graft survival.

Procedures:

Study participants will complete functional fitness assessments across the TWP, including (i) at pre-intervention or intake; (ii) post-12-week exercise intervention (EI); and (iii) after surgery (12 weeks post). Follow-up assessments will occur at 6 months and 1-year post-EI intake. Participants will complete a wellness behaviour change support session before the12-week EI. The EI can be done before or after the transplant surgery. The functional fitness assessments and the wellness behaviour support session will take approximately 30 minutes each and can be done in-person or online based on logistics and participant preference. The functional fitness assessment will include: height and weight measurements, aerobic fitness test, muscular endurance test, and the standing balance test. The Patient Reported Outcome (PRO) questionnaires will be repeated at the same time points as functional fitness assessments and then annually for 5 years. Questionnaires will be done online (REDCap). The investigators will review the participants medical chart and collect medical history at the same time points.PRO questionnaires will take approximately 20 minutes to complete and be done online. These will be completed to assess: QOL, physical activity levels, diet, sleep habits, nutrition and mental health. Participants will be requested to share their feedback upon completion of the EI through participant experience surveys and semi-structured interviews.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* In evaluation or listed (active or temporarily inactive) on the transplant waiting list (kidney or liver) - status 0, 1, or 2
* Able to provide written informed consent and understand study information in English
* Approval to exercise from Canadian Society for Exercise Physiology - Clinical Exercise Physiologist (CSEP-CEP)
* Have access to an internet connected device

Exclusion Criteria:

* Not cleared for participation in the TWP by attending physician
* Unable to provide informed consent
* Clinical condition that makes the intervention unsafe or infeasible (e.g., unable to follow instruction due to refractory encephalopathy)
* Unsafe environment for virtual participation
* Recent variceal bleeding and cannot tolerate prophylaxis with non-selective beta blockers

Primary outcomes:
measure: Self-reported exercise
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
measure: Generic self-reported quality of life
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
measure: Kidney disease quality of life.
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
measure: Liver disease quality of life
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
Secondary outcomes:
measure: Frailty
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
measure: Hand grip strength
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
measure: Lower extremity flexibility
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
measure: Aerobic Endurance
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
measure: Lower extremity muscular strength
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
measure: Balance
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
measure: Nutrition
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
measure: Sleep
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
measure: Mental Health
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
measure: Self-efficacy
timeFrame: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
measure: Program implementation and evaluation
timeFrame: Baseline to 5-years post exercise intervention
measure: Health economic evaluation
timeFrame: Baseline to 5-years post exercise intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Stefan Mustata, MD
role: PRINCIPAL_INVESTIGATOR
References: