Sim Jenna A P, Perinpanayagam Maneka A, Bahry Vanessa, Wytsma-Fisher Kathryn, Burak Kelly W, Isaac Debra L, Mustata Stefan, Culos-Reed S Nicole
Faculty of Kinesiology, University of Calgary, AB, Canada.
Department of Medicine, Cumming School of Medicine, University of Calgary, AB, Canada.
Can J Kidney Health Dis. 2024 Oct 21;11:20543581241289196. doi: 10.1177/20543581241289196. eCollection 2024.
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.
运动预康复是一种基于证据的、安全有效的方法,可提高实体器官移植(SOT)患者的生活质量、身体素质和功能以及术后效果。然而,在实际中针对SOT患者的预康复项目很少。此外,缺乏包括行为改变支持的多模式预康复项目。为满足这一需求,设计了移植健康项目(TWP)。
TWP的目的是评估针对接受肾移植或肝移植患者的综合多模式运动及健康行为改变干预措施的有效性和实施情况。
TWP是一项混合有效性-实施性试验,包括运动和健康行为改变支持。
加拿大艾伯塔省南部正在接受肾或肝移植评估或已列入移植名单的个体。
在入组时、运动干预后、入组后6个月、移植后12周以及项目完成后5年内每年评估自我报告的运动情况和生活质量等主要结局。将在入组时、运动干预后、移植后12周、入组后6个月和入组后1年评估功能性体能指标。采用覆盖、有效性、采用、实施和维持(RE-AIM)框架来确定TWP在个体和医疗系统层面的影响。
招募工作于2023年11月开始,将持续至2028年11月。参与者参加为期12周的运动干预,并获得个性化和团体行为改变支持。在12周干预结束后,通过维持课程提供持续的运动支持。
单实验组的混合有效性-实施性试验设计无法与对照组或常规护理组进行比较,可能影响内部效度。器官组(肾移植与肝移植)和队列(移植前与移植后)之间的参与者数量差异可能不均衡,在进行和解释分析时需要考虑。
TWP旨在通过多模式和综合的运动及健康行为改变项目,在整个移植过程中为患者提供支持。本研究结果将确定该项目的有效性,并为未来的扩大规模和可持续性提供信息。
NCT06367244。