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.

越来越多的患有晚期心力衰竭的患者正在接受Heartmate 3（HM3； Abbott，Abbott 伊利诺伊州公园）左心室辅助装置（LVAD）植入世界各地。尽管当代耐用 心脏的机械支持，LVAD接受者继续表现出低水平的体育活动和 功能能力，以每日步骤和六分钟的步行测试（6MWT）距离为特征，甚至在1年之后 外科手术。此外，LVAD接收者经常符合前培训/脆弱和相关肌肉减少症的标准， 包括低肌肉力量和肌肉数量。这些赤字可能有助于增加医疗保健 在这种高风险人群中的利用。 步行和加强运动可以帮助提高肌肉力量和数量以及 体育锻炼和能力，但是LVAD接受者的运动干预尚未确定。一个大 LVAD接收者的比例不参加中心，监督心脏康复（CR）和 出院后3个月，参加CR启动治疗的患者平均进行治疗。基于家庭的练习 使用移动技术的计划可以使患者在LVAD之后的早期开始运动康复 植入。我们正在对家庭锻炼计划进行随机，受控的试点研究 包括步行和加强练习的标准化协议，以指导锻炼处方和 根据从活动跟踪手表和智能手机应用程序获得的数据进行锻炼进展。我们的飞行员数据 表明我们创新的家庭锻炼计划是可行的，安全的，并且可能与更大的相关 新植入HM3 LVAD的患者的日常体育锻炼增加。 使用移动技术的家庭锻炼计划对日常体育锻炼和 LVAD接受者的容量，脆弱和肌肉减少症以及以前尚未在A中研究 多中心研究。我们提出了一项对40个LVAD中心的80名新植入HM3 LVAD患者的随机研究。 LVAD植入后指数医院出院后，将招募患者并随机分为6-- 使用移动技术或平时护理（UC）的月份新颖锻炼计划。我们将评估以下特定 目的：具体目标＃1是比较运动干预与UC对体育锻炼和 容量通过a）每日步骤（由活动监视器捕获）和b）6MWT距离。特定目标＃2 是通过评估a）脆弱的来比较运动干预与UC对脆弱和肌肉减少症的影响 状态和b）肌肉数量。特定目的＃3是比较运动干预与UC的影响 生活质量（由堪萨斯城心肌病问卷调查表衡量）。特定目标＃4是评估 运动干预与UC的成本效益。这项研究的发现有可能改善低 体育锻炼和能力，脆弱和肌肉减少症，生活质量以及医疗保健利用率提高 在不断增长的LVAD接受者中。