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

基本信息

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
项目类别：
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

项目摘要

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/摘要肺移植是一个昂贵的程序。估计成本，从移植前30天到6个月后手术，每位患者超过100万美元，此后每年的常规医疗管理费用为50,000美元。尽管进行了广泛的投资，但仍有重大挑战。移植之前，肺移植受者（LTR）由于严重的通气限制而引起的自限制活动，导致肌肉质量减少和定性大型运动骨骼肌的变化。移植后，尽管肺功能提高，但先前的研究始终报告LTR无法达到预测的身体功能或身体活动。此外，近70％的LTR 由于其免疫抑制方案和一个不活动的生活方式会使这种风险恶化。因此，可能无法实现移植的全部好处。很少研究已经测试了让LTR参与自我管理并采取积极生活方式的方法。由An 早期阶段新研究者，我们建议测试肺移植GO（LTGO），这是一种行为练习干预提供了与LTR的行为指导整合的个性化锻炼训练家。运动训练将着重于协助LTR学习和练习练习以逆转肌肉调节。行为指导将使LTR参与发展技能以自我管理的体育锻炼他们的日常生活，并使用包括逐步目标，自我的策略将其视为持续的习惯监视，反馈和解决问题。 LTGO干预包括两个阶段：第1阶段。通过TelereHabilitation Platform，Visyter的强化家庭运动培训和行为指导（用于远程审查的多功能和集成系统）。交互式干预会议将进行通过实时视频会议（12周内的10次会议）的房屋；和第2阶段。过渡到自我管理。四个电话会议（1个行为合同 + 3个每月咨询会议）将是超过12周以提供行为指导和锻炼强化。我们激动人心的飞行员工作成功证明了LTGO改善身体机能和身体的可行性，安全性和能力活动并热情地接受。我们将进行比较的两组随机对照试验 LTGO反对增强的常规护理（EUC）。参与者将为112 LTR随机分配到LTGO或EUC（1：1）。结果将在基线和随机化后3和6个月进行测量。主要结果是身体功能（步行能力[6分钟步行测试]，平衡[Berg Balance量表]，下身体强度[30- 第二个椅子立式测试]和股四头肌强度[Biodex System 3 Pro]）和体育锻炼（Actigraph GT3X）。第二结果是血压控制（防止高血压发作或控制现有的高血压）。潜在的调解人将是运动自我效能和自我监控（Fitbit 充电HR）。潜在的主持人将是性别和临床因素（症状，移植前和移植后临床数据）。调查结果将提供有关LTGO功效的证据，以改善运动自我 LTR的管理，并有可能受益于患有其他复杂慢性病的人。