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

HEART Camp Connect：促进射血分数保留的心力衰竭成人患者坚持锻炼

• 批准号: 10657083
• 负责人: Windy Williams Alonso
• 金额: $ 70.27万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-15 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10657083
• 关键词: Adherence; Adult; Algorithms; Area; Attitude; Behavior Therapy; Behavioral Mechanisms; Benchmarking; Biological Assay; Biological Markers; Cardiovascular system; Caring; Clinical; Congestive Heart Failure; Cost Analysis; Costs and Benefits; Data; Direct Costs; EFRAC; Evaluation; Event; Exercise; Exercise Test; Facilities and Administrative Costs; Future; Goals; Guidelines; Health Status; Heart Rate; Heart failure; Hospitalization; Inflammation; Inflammatory; Informal Social Control; Injury; Intervention; Intervention Trial; Measures; Mediating; Mediation; Mediator; Medicine; National Heart, Lung, and Blood Institute; Outcome; Participant; Patient Outcomes Assessments; Patients; Perception; Persons; Physical Function; Physical activity; Physiological; Quality of life; Randomized, Controlled Trials; Recommendation; Science; Self Efficacy; Subgroup; Symptoms; Testing; Theoretical Studies; Time; Training; Treatment Efficacy; Work; behavior change; behavioral adherence; clinical care; cost effective; cost-effectiveness ratio; design; efficacy testing; exercise adherence; exercise intensity; exercise intervention; exercise intolerance; exercise training; experience; improved; incremental cost-effectiveness; innovation; intervention cost; intervention delivery; mortality; pharmacologic; preservation; primary outcome; resistance exercise; secondary analysis; theories; therapy design; treatment as usual; virtual; virtual coach; virtual delivery; web app; working group

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.

项目概要/摘要 射血分数保留的心力衰竭（HFpEF）是最大的治疗挑战之一 今天的心血管护理。运动是少数对 HFpEF 成人患者有益的治疗方法之一。然而，要实现 并维持锻炼的好处，需要坚持。最近的国家心肺和血液研究所 (NHLBI) HFpEF 和心力衰竭运动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 提高运动依从性的介入机制，确定具有临床意义的心脏结果 超越死亡率的失败试验，并检查炎症生物标志物的纵向变化，以更好地 了解与临床状态的相关性。我们的团队已成功测试了一项干预措施[心力衰竭运动 和阻力训练 (HEART) 营] 可显着提高对中等强度的长期坚持 稳定的慢性心力衰竭患者进行锻炼（≥120 分钟的锻炼，心率储备为 40-80%）。依从性 由射血分数调节，并且我们的 HFpEF 亚组的二次分析显示出有希望的长期治疗 长期锻炼坚持。我们现在提出一项足够有力的随机对照试验来测试疗效 2 种干预措施可帮助 HFpEF 成人实现长期运动坚持。我们的总体目标一致 遵循 NHLBI 的优先事项，并努力实现我们的长期目标，以促进 HFpEF 患者坚持锻炼： (a) 评估基于理论的训练和辅导干预对长期坚持运动的影响， (b) 确定与患者报告的有临床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因素 行为，以及 (d) 检查干预实施的成本。为了实现这些目标，我们提出了 3 组 比较 2 种干预措施的随机对照试验：HEART Camp（亲自）与 HEART Camp Connect （虚拟）相互交流并加强 HFpEF 成人的常规护理。拟议的研究包括几个 创新： 1. 我们是第一个：测试旨在促进长期的行为干预措施的效果 使用客观的依从性测量来锻炼 HFpEF 的依从性，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. 我们采用了技术创新，包括用于实时捕获运动数据的网络应用程序， 一种创新的分析方法，检查临时临床事件对依从性的影响，即 HFpEF 算法和大规模炎症测定。这些创新挑战了当前的范式并有助于 达到 HFpEF 科学的新视野。我们的方法结合了经过充分研究的理论机制 通过与现场辅导和培训进行测试的虚拟辅导和培训，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依从性产生重大影响 通过定期运动训练对成人 HFpEF 进行临床护理取得进展的障碍。