RecruitingNot ApplicableNCT06367244

Transplant Wellness Program

Exercise and Wellness Behaviour Change for Solid Organ Transplant: A Hybrid Effectiveness-Implementation Trial of the Transplant Wellness Program


Sponsor

University of Calgary

Enrollment

420 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

BEHAVIORALTransplant Wellness Program - Kidney and Liver

The exercise prescription for the intervention will be multimodal, , will follow current chronic disease exercise guidelines, and will be tailored to meet the unique needs of each participant. . All participants will receive two 30-45-minute individual session with a CEP during their first week and two additional sessions during the second week if needed. The individual sessions will be followed by group sessions. Each participant will get a total of 24 individual and group sessions combined. These sessions can be conducted either in-person or online, based on participant preference and TWP logistics. For aerobic-based activities, a moderate rate of perceived exertion of 4-6 on a scale of 0-10 will be used. Resistance exercise will begin with functional movements and bodyweight exercises targeting major muscle groups with modifications for beginners and exercise progressions when deemed. Balance and flexibility training activities will also be included.


Locations(1)

University of Calgary

Calgary, Alberta, Canada

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NCT06367244


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