HEART Camp Connect: Promoting Adherence to Exercise in Adults with Heart Failure with Preserved Ejection Fraction

项目摘要/摘要 射血分数保留的心力衰竭是最大的治疗挑战之一。 今天的心血管护理。运动是为数不多的对患有HFpEF的成年人有益的治疗方法之一。然而，要实现 并保持锻炼的好处，坚持是必要的。新近成立的国家心肺血液研究所 (NHLBI)关于HFpEF和运动治疗心力衰竭的工作组强调了未来研究的高度优先领域 包括检查促进运动开始和坚持的策略和干预措施、测试 改善运动依从性的干预机制，确定对心脏有临床意义的结果 失败的试验超过死亡率，并检查炎症生物标志物的纵向变化，以更好地 了解与临床状态相关。我们的团队成功地测试了一种干预措施[心力衰竭锻炼 和阻力训练(心脏)营]，显著提高长期坚持中等强度 运动(≥120分钟，心率储备为40-80%)用于稳定的慢性心力衰竭。坚守 是由射血分数调节的，对我们的HFpEF亚组的二次分析显示出有希望的长期- 坚持学期锻炼。我们现在提出一个足够强大的随机对照试验来测试疗效。 在HFpEF成人中实现长期运动坚持的两种干预措施。我们的总体目标一致 根据NHLBI的优先事项，努力实现我们的长期目标，促进坚持在HFpEF锻炼： (A)评估以理论为基础的训练和教练干预对长期坚持锻炼的影响； (B)确定与患者报告的临床有意义的变化相关的中等强度运动的分钟数 结果，(C)评估干预机制和临时临床事件作为依从性的中介 以及(D)检查提供干预措施的成本。为了实现这些目标，我们建议成立一个三人小组 比较两种干预措施的随机对照试验，心营(面对面)和心营连接 (虚拟)相互之间，并加强对患有HFpEF的成年人的日常护理。这项拟议的研究包括几项 创新：1.我们率先测试旨在促进长期健康发展的行为干预措施的效果 在HFpEF中使用遵守的客观衡量标准来练习遵守，尝试定义一个基准 实现有临床意义的改变所需的运动分钟数，并评估运动干预成本； 2.我们融入了技术创新，包括用于实时捕获运动数据的Web应用程序， 一种创新的分析方法，考察临时临床事件对依从性的影响 算法和大规模炎症检测。这些创新挑战了当前的模式，并有助于 达到HFpEF科学的新境界。我们的方法结合了经过充分研究的理论机制 提供虚拟教练和培训，与面对面的教练和培训进行对比测试，将使我们能够更好地 了解HFpEF中的运动依从性。这项研究将通过减少不遵守的情况产生关键影响 通过定期运动训练，阻碍成人高压性肺功能衰竭的临床护理进展。

PROJECT SUMMARY/ABSTRACT Heart failure with preserved ejection fraction (HFpEF) is one of the greatest treatment challenges in cardiovascular care today. Exercise is one of few treatments shown to benefit adults with HFpEF. Yet, to achieve and sustain the benefits of exercise, adherence is required. Recent National Heart Lung and Blood Institute (NHLBI) working groups on HFpEF and exercise in heart failure highlighted high priority areas for future study including examining strategies and interventions to promote exercise initiation and adherence, testing interventional mechanisms to improve adherence to exercise, identifying clinically meaningful outcomes for heart failure trials beyond mortality, and examining longitudinal changes in inflammatory biomarkers to better understand correlates to clinical status. Our team has successfully tested an intervention [Heart Failure Exercise and Resistance Training (HEART) Camp] that significantly improves long-term adherence to moderate intensity exercise (≥120 minutes of exercise at a heart rate reserve of 40-80%) in stable, chronic heart failure. Adherence was moderated by ejection fraction and a secondary analysis of our HFpEF subgroup showed promising long- term exercise adherence. We now propose a sufficiently powered randomized controlled trial to test the efficacy of 2 interventions in achieving long-term exercise adherence in adults with HFpEF. Our overall objectives align with NHLBI priorities and work toward achieving our long-term goal to promote adherence to exercise in HFpEF: (a) evaluate the effects of theory-based training and coaching interventions on long-term adherence to exercise, (b) identify minutes of moderate-intensity exercise that relate to clinically meaningful change in patient-reported outcomes, (c) evaluate interventional mechanisms and interim clinical events as mediators of adherence behaviors, and (d) examine the cost of intervention delivery. To meet these objectives, we propose a 3-group randomized controlled trial to compare 2 interventions, HEART Camp (in-person) to HEART Camp Connect (virtual) to each other and to enhanced usual care in adults with HFpEF. The proposed study incorporates several innovations: 1. We are the first to: test the effects of behavioral interventions designed to promote long-term exercise adherence in HFpEF using an objective measure of adherence, attempt to define a benchmark of minutes of exercise needed to achieve a clinically meaningful change, and assess exercise intervention cost; and 2. We incorporate technical innovations including a web application for real-time capture of exercise data, an innovative analytic approach that examines the influence of interim clinical events on adherence, a HFpEF algorithm and large-scale inflammatory assays. These innovations challenge the current paradigm and help to reach new horizons in HFpEF science. Our approach, which combines well-studied theoretical mechanisms delivered with virtual coaching and training tested against in-person coaching and training, will allow us to better understand exercise adherence in HFpEF. This study will have a critical impact by lessening non-adherence as a barrier to progress in the clinical care of adults with HFpEF through regular exercise training.