Home-based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation

左心室辅助装置植入后使用移动技术的家庭锻炼计划

• 批准号: 10563304
• 负责人: Himabindu Vidula
• 金额: $ 53.52万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-11 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10563304
• 关键词: Accelerometer; Activities of Daily Living; Cardiac rehabilitation; Cardiomyopathies; Cities; Cost Analysis; Cost Savings; Costs and Benefits; Data; Enrollment; Exercise; Exertion; Health; Health Care Rationing; Heart failure; Home; Hospitals; Implant; Kansas; Measures; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multicenter Studies; Muscle; Operative Surgical Procedures; Participant; Patient Participation; Patients; Pectoralis Muscles; Physical Capacity; Physical activity; Pilot Projects; Population; Protocols documentation; Quality of life; Questionnaires; Randomized; Rehabilitation therapy; Reporting; Scanning; Standardization; Testing; Time; Walking; chest computed tomography; exercise intervention; exercise physiologist; exercise prescription; exercise program; exercise rehabilitation; frailty; group intervention; health care service utilization; high risk population; implantation; improved; indexing; innovation; intervention cost; left ventricular assist device; mechanical circulatory support; mobile computing; mortality; muscle strength; novel; patient population; reduced muscle strength; sarcopenia; smartphone application; treatment as usual; video chat

A growing number of patients with advanced heart failure are undergoing HeartMate 3 (HM3; Abbott, Abbott Park, IL) left ventricular assist device (LVAD) implantation around the world. Despite contemporary durable mechanical support of the heart, LVAD recipients continue to demonstrate low levels of physical activity and functional capacity, characterized by daily steps and six-minute walk test (6MWT) distance, even 1-year after surgery. In addition, LVAD recipients frequently meet criteria for prefrailty/frailty and associated sarcopenia, including low muscle strength and muscle quantity. These deficits may contribute to increased healthcare utilization in this high-risk population. Walking and strengthening exercises can help to improve muscle strength and quantity as well as physical activity and capacity, but exercise interventions in LVAD recipients are not well established. A large proportion of LVAD recipients do not participate in center-based, supervised cardiac rehabilitation (CR), and patients participating in CR initiate therapy a mean of 3 months after hospital discharge. A home-based exercise program using mobile technology may allow patients to begin exercise rehabilitation at an earlier time after LVAD implantation. We are conducting a randomized, controlled pilot study of a home-based exercise program including walking and strengthening exercises with a standardized protocol to guide exercise prescription and exercise progression based on data obtained from an activity tracking watch and smartphone app. Our pilot data suggest that our innovative home-based exercise program is feasible, safe, and may be associated with a greater increase in daily physical activity in patients newly implanted with a HM3 LVAD. The effects of a home-based exercise program using mobile technology on daily physical activity and capacity, frailty and sarcopenia, and quality of life in LVAD recipients have not been previously studied in a multicenter study. We propose a randomized study of 80 newly implanted HM3 LVAD patients at 4 LVAD centers. Following index hospital discharge after LVAD implantation, patients will be enrolled and randomized to a 6- month novel exercise program using mobile technology or usual care (UC). We will evaluate the following specific aims: Specific Aim #1 is to compare the effects of the exercise intervention vs. UC on physical activity and capacity measured by a) daily steps (captured by the activity monitor) and b) 6MWT distance. Specific Aim #2 is to compare the effects of the exercise intervention vs. UC on frailty and sarcopenia, by evaluating a) frailty status and b) muscle quantity. Specific Aim #3 is to compare the effects of the exercise intervention vs. UC on quality of life (measured by the Kansas City Cardiomyopathy Questionnaire-12). Specific Aim #4 is to evaluate the cost-benefit of the exercise intervention vs. UC. Findings from this study have the potential to improve low physical activity and capacity, frailty and sarcopenia, quality of life, and increased rates of healthcare utilization in the growing population of LVAD recipients.

越来越多的晚期心力衰竭患者正在接受HeartMate 3（HM 3; Abbott，Abbott Park，IL）左心室辅助装置（LVAD）植入。尽管现代耐用 在心脏的机械支持下，LVAD接受者继续表现出低水平的身体活动， 功能能力，以每日步数和6分钟步行测试（6 MWT）距离为特征，即使在1年后 手术此外，LVAD接受者经常符合前虚弱/虚弱和相关肌肉减少症的标准， 包括肌肉力量和肌肉量低。这些赤字可能有助于增加医疗保健 在这一高风险人群中的应用。 步行和加强锻炼可以帮助提高肌肉力量和数量，以及 身体活动和能力，但运动干预LVAD接受者还没有很好地建立。大 LVAD接受者不参加基于中心的监督心脏康复（CR）的比例，以及 参与CR的患者在出院后平均3个月开始治疗。一个以家庭为基础的练习 使用移动的技术的程序可以允许患者在LVAD后的较早时间开始运动康复 置入我们正在进行一项随机对照的试点研究， 包括步行和加强锻炼，并采用标准化方案指导运动处方， 运动进展基于从活动跟踪手表和智能手机应用程序获得的数据。我们的试点数据 这表明，我们创新的家庭锻炼计划是可行的，安全的，并可能与更大的 新植入HM 3 LVAD的患者的日常体力活动增加。 使用移动的技术的家庭锻炼计划对日常身体活动和 容量，虚弱和肌肉减少症，以及LVAD接受者的生活质量以前没有研究过。 多中心研究。我们建议在4个LVAD中心对80例新植入HM 3 LVAD患者进行随机研究。 LVAD植入后出院后，患者将入组并随机分配至6- 使用移动的技术或常规护理（UC）的一个月新锻炼计划。我们将评估以下具体 目的：具体目的#1是比较运动干预与UC对身体活动的影响， 通过a）每日步数（由活动监测器捕获）和B）6 MWT距离测量的能力。具体目标#2 通过评估a）虚弱，比较运动干预与UC对虚弱和肌肉减少的影响 状态和B）肌肉量。具体目标#3是比较运动干预与UC对 生活质量（通过堪萨斯城心肌病问卷-12测量）。目标#4：评估 运动干预与UC的成本效益。这项研究的结果有可能改善低 体力活动和能力，虚弱和肌肉减少症，生活质量和医疗保健利用率增加 越来越多的左心室辅助装置接受者