Home-based cardiac rehabilitation using a novel mobile health exercise regimen following transcatheter heart valve interventions (HOME RUN HITTER)

在老年人中，心脏瓣膜疾病很常见，通常需要瓣膜修复或治疗 替补。过去需要心内直视手术的手术现在可以用侵入性更小的经导管心脏来完成 瓣膜介入治疗(THVI)，发病率较低，恢复较快。然而，尽管安全和 THVI的手术成功，超过一半的患者死亡，生活质量(QOL)差，和/或 THVI术后1年住院治疗。心脏康复(CR)有效地缓解了这些不良结局 心血管疾病患者，包括接受心脏瓣膜手术的患者。然而，在 联邦医疗保险受益人，接受THVI的人中只有25%参加了以中心为基础的CR(CBCR)，即 突出了一个重要的未得到满足的临床需求。为了满足这一需求，我们的长期目标是发展一个家园- 基于CR(HBCR)计划，将CR的好处扩展到THVI后的更多个人。我们的拱顶 假设HBCR移动健康干预创新地解决了关键的目标健康行为 将减少临床事件，改善THVI后的体力活动、功能能力和生活质量， 互动交付和更长的积极干预持续时间将产生更大的好处。我们提出了一个 375例接受主动脉或二尖瓣超声心动图检查的患者的多中心随机对照试验 打算参加《生物多样性公约》；将在登记处跟踪那些打算从事《生物多样性公约》的人。参与者将 被分成3组：对照组(1)与HBCR无干预移动健康干预(2)与互动式(3) 送货。该干预措施针对主要目标健康行为，并包括Apple Watch(以鼓励 体育锻炼，并提醒健康生活)和运动处方(以增强力量/平衡)。 不插手和交互式交付组接受相同的干预，但视频呼叫(每隔 其他周)与运动生理学家(仅限互动式小组)。每个干预组(不插手， 互动)将被随机分为12周和24周的积极干预时间。联合初选 终点是：(1)综合临床事件(死亡、再住院、熟练护理机构访问)；以及(2) 日均总活动量计入。关键次要终点：体力活动的量、强度、一致性； 步行6分钟距离；以及QOL。我们测试HBCR移动健康干预是否(与对照组相比) 减少临床事件，改善THVI后的体力活动、功能能力和生活质量(目标1)和 无论是交互交付与免提交付(目标2)，还是24周与12周的活动持续时间(目标3) 干预会带来更大的好处。我们还探讨了临床利益的中介因素和行为机制。 变化。随着人口老龄化，心脏瓣膜病的患病率和THVI的数量正在迅速增加。 克服与严重瓣膜疾病相关的残疾需要的不仅仅是简单地修复瓣膜； 如果不整合CR，THVI改善生活数量和质量的潜力就无法实现。如果成功，我们的 该方法将优化护理价值和患者结果，并对其他患者群体产生广泛影响。

Among older adults, heart valve disease is common and often requires treatment with valve repair or replacement. What used to require open heart surgery can now be done with less invasive transcatheter heart valve interventions (THVIs), allowing for less morbidity and quicker recovery. However, despite the safety and procedural success of THVIs, over one-half of patients are dead, have poor quality of life (QoL), and/or are hospitalized 1 year after a THVI. Cardiac rehabilitation (CR) effectively mitigates these poor outcomes in patients with cardiovascular disease, including those undergoing heart valve procedures. However, among Medicare beneficiaries, only 25% of those undergoing a THVI participate in center-based CR (CBCR), which highlights a significant unmet clinical need. To address this need, our long-term goal is to develop a home- based CR (HBCR) program that extends the benefits of CR to more individuals after THVIs. Our over-arching hypothesis is that a HBCR mobile health intervention that innovatively addresses key target health behaviors will reduce clinical events and improve physical activity, functional capacity, and QoL after THVIs and that an interactive delivery and longer duration of the active intervention will produce greater benefits. We propose a multicenter randomized controlled trial enrolling 375 patients undergoing aortic or mitral THVIs who do not intend to participate in CBCR; those who intend to pursue CBCR will be followed in a registry. Participants will be assigned to 3 groups: control (1) vs. a HBCR mobile health intervention with hands-off (2) vs. interactive (3) delivery. The intervention addresses key target health behaviors and includes Apple Watch (to encourage physical activity and give reminders on healthy living) and an exercise prescription (to build strength/balance). The hands-off and interactive delivery groups receive the same intervention, except for a video call (every other week) with an exercise physiologist (interactive group only). Each intervention group (hands-off, interactive) will be randomized to 12-week vs. 24-week duration of the active intervention. The co-primary endpoints are: (1) clinical events composite (death, rehospitalization, skilled nursing facility visits); and (2) average daily total activity counts. Key secondary endpoints: amount, intensity, consistency of physical activity; 6-minute walk distance; and QoL. We test whether the HBCR mobile health intervention (compared to control) reduces clinical events and improves physical activity, function capacity, and QoL after THVI (Aim 1) and whether interactive vs. hands-ff delivery (Aim 2) or 24-week vs. 12-week active duration (Aim 3) of the intervention yields greater benefits. We also explore mediators of clinical benefit and mechanisms of behavior change. With population aging, prevalence of heart valve disease and number of THVIs are rapidly increasing. Overcoming disablement associated with severe valve disease requires more than simply fixing a valve; the potential of THVIs to improve quantity and quality of life is unfulfilled without integrating CR. If successful, our approach will optimize value of care and patient outcomes with broad implications for other patient populations.