Lung Transplant Go (LTGO): Improving Self-Management of Exercise After Lung Transplantation

7.项目总结/摘要 肺移植是一项昂贵的手术。从移植前30天到移植后6个月的估计费用 外科手术，每名病人超过100万美元，此后每年例行医疗管理费用为50 000美元。 尽管进行了大量投资，但仍然存在重大挑战。在移植之前，肺移植受者 (LTR)由于严重的限制性限制，自我限制活动，导致肌肉质量和质量减少 大的运动骨骼肌的变化。移植后，尽管肺功能改善，先前的研究 持续报告LTR未能达到预期的身体功能或身体活动。此外，近70%的LTR 由于免疫抑制方案，在前5年内有发生高血压的风险， 不积极的生活方式会加重这种风险。因此，移植的全部益处可能无法实现。几 研究已经测试了让LTR自我管理锻炼和采取积极生活方式的方法。由一个 新研究员，我们建议测试肺移植Go（LTGO），一种行为练习 干预，提供个性化的运动训练，结合行为指导，为LTR， 回家运动训练将侧重于协助LTR学习和练习运动，以扭转肌肉 去适应行为指导将使LTR参与发展自我管理身体活动的技能， 他们的日常生活，并保持这作为一个持续的习惯，使用的策略，包括增量目标设定，自我， 监控反馈和解决问题。LTGO干预包括两个阶段：第一阶段。 通过远程康复平台VISYTER进行强化的家庭运动训练和行为指导 （多功能和集成的远程康复系统）。互动干预会议将提供给 家庭通过真实的时间视频会议（12周内10次会议）;和第2阶段。向自我过渡- 管理四次电话会议（1次行为合同+3次每月咨询会议）将在 提供超过12周的行为指导和锻炼强化。我们激动人心的试点工作 成功地证明了LTGO的可行性，安全性和改善身体功能和身体的能力， 活动，并受到热烈欢迎。我们将进行两组随机对照试验， LTGO与增强型常规护理（EUC）。112例LTR受试者将被随机分配至LTGO或EUC（1：1）。 将在基线、随机化后3个月和6个月测量结局。主要结局 身体功能（步行能力[6分钟步行试验]、平衡[贝格平衡量表]、下半身力量[30- 第二次椅子站立测试]和股四头肌肌肉力量[Biodex System 3 Pro]）和体力活动 （Actigraph GT3X）。次要结局是血压控制（预防高血压发作或 控制现有的高血压）。潜在的中介将是运动自我效能和自我监测（Fitbit 充电HR）。潜在的调节因素将是性别和临床因素（症状、移植前和移植后的临床 数据）。研究结果将提供有关LTGO作为改善运动自我的一种手段的有效性的证据。 LTR的管理，并可能受益于患有其他复杂慢性疾病的个体。

7. PROJECT SUMMARY/ ABSTRACT Lung transplantation is a costly procedure. Estimated costs, from 30 days prior to transplant to 6 months post- surgery, exceed $1 million per patient and routine medical management costs $50,000 per year thereafter. Despite this extensive investment, major challenges remain. Prior to transplant, lung transplant recipients (LTR) self-restrict activity due to severe ventilatory limitation, resulting in reduced muscle mass and qualitative changes in large exercising skeletal muscles. After transplant, despite improved lung function, prior studies consistently report LTR fail to reach predicted physical function or physical activity. Further, nearly 70% of LTR are at risk of developing hypertension within first 5 years due to their immunosuppressive regimen and an inactive lifestyle can worsen this risk. Consequently, full benefits of transplant may not be achieved. Few studies have tested ways to engage LTR to self-manage exercise and adopt an active lifestyle. Initiated by an Early Stage New Investigator, we propose to test Lung Transplant Go (LTGO), a behavioral exercise intervention that provides individualized exercise training integrated with behavioral coaching for LTR in their home. Exercise training will focus on assisting LTR to learn and practice exercises to reverse muscle deconditioning. Behavioral coaching will engage LTR in developing skills to self-manage physical activity in their daily life and maintain this as a sustained habit using strategies that include incremental goal setting, self- monitoring and feedback and problem solving. The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation). Interactive intervention sessions will be delivered to the home via real time video conferencing (10 sessions within 12 weeks); and Phase 2. Transition to self- management. Four telephone sessions (1 behavioral contract + 3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement. Our exciting pilot work successfully demonstrated the feasibility, safety and ability of LTGO to improve physical function and physical activity and was enthusiastically received. We will conduct a two-group randomized controlled trial comparing LTGO against enhanced usual care (EUC). Participants will be 112 LTR randomized to LTGO or EUC (1:1). Outcomes will be measured at baseline, and 3 and 6 months post-randomization. Primary outcomes are physical function (walking ability [6-Minute Walk Test], balance [Berg Balance Scale], lower body strength [30- second Chair-Stand Test], and quadriceps muscle strength [Biodex System 3 Pro]) and physical activity (Actigraph GT3X). Secondary outcome is blood pressure control (preventing onset of hypertension or controlling existing hypertension). Potential mediators will be exercise self-efficacy and self-monitoring (Fitbit Charge HR). Potential moderators will be sex and clinical factors (symptoms, pre- and post-transplant clinical data). Findings will provide evidence regarding efficacy of the LTGO as a means to improve exercise self- management in LTR and, potentially, benefit in individuals living with other complex chronic conditions.