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

肺移植 Go (LTGO)：改善肺移植后运动的自我管理

• 批准号: 9901633
• 负责人: ANNETTE J DE VITO DABBS
• 金额: $ 54.13万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9901633
• 关键词: Activities of Daily Living; Address; Adopted; Attention; Behavioral; Characteristics; Charge; Clinical; Clinical Data; Contracts; Counseling; Discipline; Discipline of Nursing; Enrollment; Equilibrium; Exercise; Exhibits; Feedback; Goals; Habits; Health; Healthcare; Home environment; Hypertension; Immune system; Immunosuppressive Agents; Individual; Institution; Intervention; Investments; Learning; Life; Life Style; Lung Transplantation; Measures; Mediating; Mediator of activation protein; Medical; Medical center; Monitor; Muscle; Operative Surgical Procedures; Outcome; Participant; Patients; Perception; Personal Satisfaction; Phase; Physical Exercise; Physical Function; Physical activity; Problem Solving; Protocols documentation; Psychological reinforcement; Quality of Care; Randomized; Randomized Controlled Trials; Regimen; Reporting; Research Personnel; Respiratory physiology; Risk; Safety; Savings; Schedule; Science; Self Efficacy; Self Management; Skeletal Muscle; Supervision; Symptoms; System; Telephone; Testing; Time; Training; Transplant Recipients; Transplantation; Travel; Universities; Walking; Work; actigraphy; active lifestyle; base; blood pressure regulation; clinical practice; complex chronic conditions; cost; cost estimate; deconditioning; exercise intervention; exercise training; fitbit; flexibility; impression; improved; improved outcome; innovation; multi-component intervention; muscle strength; post-transplant; prevent; primary outcome; procedure cost; programs; psychologic; pulmonary rehabilitation; quadriceps muscle; reduced muscle mass; secondary outcome; sex; skills; symposium; telerehabilitation; treatment as usual; trial comparing

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.

7.项目摘要/摘要 肺移植是一项昂贵的手术。估计费用，从移植前30天到移植后6个月- 每名患者手术费用超过100万美元，此后每年常规医疗管理费用为50,000美元。 尽管进行了大量投资，但重大挑战依然存在。在移植之前，肺移植接受者 (Ltr)由于严重的通风限制而自我限制活动，导致肌肉质量和质地减少 大运动量骨骼肌的变化。移植后，尽管肺功能有所改善，但先前的研究 始终如一地报告LTR未能达到预期的身体功能或身体活动。此外，近70%的LTR 在头5年内有患高血压的风险，因为他们的免疫抑制方案和 不活跃的生活方式会加剧这种风险。因此，移植的全部好处可能无法实现。一些 研究已经测试了让LTR自我管理运动和采取积极生活方式的方法。由一个 早期新研究人员，我们建议测试肺移植GO(LTGO)，一种行为练习 提供个性化运动训练与行为指导相结合的干预措施 回家。运动训练的重点是帮助LTR学习和练习反转肌肉的练习 解除条件。行为指导将使LTR发展自我管理体力活动的技能 他们的日常生活，并将其作为一种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 (多功能远程康复综合系统)互动干预课程将提供给 家庭通过实时视频会议(12周内10次会议)；和阶段2。过渡到自我 管理层。将举行四次电话会议(1次行为合同+3次月度咨询会议) 提供超过12周的培训，提供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改善身体机能和体能的可行性、安全性和能力 活动，受到了热烈的欢迎。我们将进行两组随机对照试验 LTGO反对加强日常护理(EUC)。参与者将被随机分配到LTGO或EUC(1：1)。 结果将在基线以及随机化后3个月和6个月进行评估。主要结果是 身体功能(步行能力[6分钟步行测试]、平衡[Berg平衡量表]、下半身力量[30- 第二椅子-站立测试]，股四头肌肌肉力量[Biodex System 3 Pro])和体力活动 (Actigraph GT3X)。次要结果是血压控制(预防高血压或 控制现有的高血压)。潜在的中介变量是运动自我效能感和自我监控(Fitbit 收费人力资源)。潜在的调节因素是性别和临床因素(症状、移植前和移植后的临床 数据)。研究结果将为LTGO作为提高运动自我的一种手段的有效性提供证据 对慢性阻塞性肺疾病的管理，并可能使患有其他复杂慢性病的个人受益。