An Exercise and Wellness Behavior Change Program for Solid Organ Transplant: A Clinical Research Protocol for the...

Exercise prehabilitation is an evidence-based, safe, and effective method to increase quality of life, physical fitness and function, and post-surgical outcomes in solid organ transplant (SOT) patients. However, few prehabilitation programs for SOT patients exist in practice. Furthermore, there is a lack of multimodal prehabilitation programs that include behavior change support. To address this need, the Transplant Wellness Program (TWP) was designed.

The objective of the TWP is to assess both the effectiveness and implementation of a comprehensive and multimodal exercise and wellness behavior change intervention for patients undergoing kidney or liver transplant.

The TWP is a hybrid effectiveness-implementation trial consisting of exercise and wellness behavior change support.

Individuals who are in evaluation or listed for kidney or liver transplant in Southern Alberta, Canada.

The primary outcomes of self-reported exercise and quality of life are assessed at intake, post-exercise intervention, 6 months post-intake, 12 weeks post-transplant, and annually for 5 years after program completion. Functional fitness measures will be assessed at intake, post-exercise intervention, 12 weeks post-transplant, 6 months post-intake, and 1-year post-intake. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework is used to determine the impact of TWP at the individual and health care system level.

Recruitment began in November 2023 and will continue until November 2028. Participants take part in a 12-week exercise intervention and are offered individualized and group behavior change support. Continued exercise support is offered through maintenance classes after the completion of the 12-week intervention.

The design of the hybrid effectiveness-implementation trial with a single experimental group will not allow for comparisons to a control or usual care group, potentially impacting internal validity. Differences in number of participants between organ groups (kidney vs liver) and cohorts (pre-transplant vs post-transplant) will likely be uneven, requiring consideration when running and interpreting analyses.

The TWP aims to support patients throughout the transplant journey through a multimodal and comprehensive exercise and wellness behavior change program. Results from this study will determine the effectiveness of the program and inform future scale-up and sustainability.

NCT06367244.