REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

描述(申请人提供)：急性失代偿性心力衰竭(ADHF)是老年人住院的主要原因，它显著恶化生活质量，增加死亡率和医疗费用，并已被CMS宣布为国家优先事项。然而，目前的管理策略对ADHF的再住院只有轻微的影响，最近的试验一直是负面的，这表明需要一种新的方法。多条证据表明，身体功能的严重损害强烈地导致了老年ADHF患者的不良结局。即使病情稳定并得到了很好的补偿，患有慢性心力衰竭的老年患者也会有严重的身体功能损害，当他们过渡到ADHF时，这种损害会明显恶化。与医院有关的因素，包括被迫卧床休息，进一步加剧了这种情况。出院后，患者在力量、平衡、活动能力和耐力方面继续存在明显的障碍。大多数患者符合虚弱的正式定义，有些患者从未恢复过基线功能。这发生在早期再住院和不良后果的高危时期。我们推测，这种导致持续性严重身体功能障碍的级联事件是老年心衰患者再住院率高的原因之一。然而，目前的心力衰竭管理模式并没有解决身体功能的显著损害，慢性或急性心力衰竭都不是心脏康复的批准适应症。此外，运动训练试验排除了ADHF，也没有包括平衡、力量和活动能力等领域，这些领域对于预防虚弱的老年患者的伤害非常重要。为了解决这一关键的证据缺口，我们开发了一种新颖的、量身定制的、渐进的、多学科的12周康复干预措施，从住院期间开始，旨在解决老年ADHF患者身体功能的特定缺陷。在我们的初步研究中，这项干预是安全的，并使短身体表现电池(SPPB)评分提高了17.9%，各种原因导致的再住院人数减少了29.3%。SPPB评分的变化解释了全原因再住院人数减少的90%。这项拟议研究的主要目的是在360名患有ADHF的老年患者中进行一项多中心、随机、对照、单盲试验，以检验康复-HF干预将改善SPPB测量的身体功能的主要具体假设。第二个目的是收集6个月随访期间的临床结果数据，以验证康复-心力衰竭干预组6个月全因再住院率降低的假设。调查人员是一支凝聚力强、经验丰富的多学科团队，来自三个成熟的地点。通过测试一种由多水平证据支持的新型干预措施，Rehab-HF试验将解决ADHF老年患者护理方面的关键证据缺口，ADHF是最常见的医疗保险出院诊断。康复-心力衰竭的结果可以改变临床管理模式，改善功能，降低成本，并改变每年住院的100万老年ADHF患者的医疗保健政策。

DESCRIPTION (provided by applicant): Acute decompensated heart failure (ADHF) is the leading cause of hospitalizations in older persons, which markedly worsen quality-of-life, increase mortality and health care costs, and have been declared a national priority by CMS. However, current management strategies have had only modest impact on rehospitalizations for ADHF, and recent trials have been negative, suggesting a need for a new approach. Multiple lines of evidence suggest that severe impairments in physical function strongly contribute to adverse outcomes in older ADHF patients. Even when stable and well-compensated, older patients with chronic HF have severe impairments in physical function, which markedly worsen as they transition to ADHF. These are further exacerbated by hospital-related factors, including forced bed rest. After discharge, patients continue to have marked impairments in strength, balance, mobility, and endurance. Most patients meet formal definitions of frailty, and some never recover baseline function. This occurs during the highest risk period for early rehospitalization and adverse outcomes. We hypothesize that this cascade of events resulting in persistent, severe physical dysfunction contributes to the high rates of rehospitalization in older HF patients. However, current HF management paradigms do not address the marked impairments in physical function, and neither chronic nor acute HF are approved indications for cardiac rehabilitation. Furthermore, exercise training trials have excluded ADHF, and have also not included the domains of balance, strength and mobility which are important for preventing injuries in frail, older patients. To address this critical evidence gap, we developed a novel, tailored, progressive, multidisciplinary 12-week rehabilitation intervention beginning during hospitalization and designed to address the specific deficits in physical function of older ADHF patients. In our pilot study, this intervention was safe and produced a 17.9% improvement in the Short Physical Performance Battery (SPPB) score and a 29.3% reduction in all-cause rehospitalizations. The change in the SPPB score explained 90% of the reduction in all-cause rehospitalizations. The primary aim of the proposed study (REHAB-HF) is to conduct a multi-center, randomized, controlled, single-blind trial in 360 older patients with ADHF to test the primary specific hypothesis that the REHAB-HF intervention will improve physical function, as measured by the SPPB. The secondary aim is to collect clinical outcomes data during 6-month follow-up to test the hypothesis that the REHAB-HF intervention group will have a reduced 6-month all-cause rehospitalization rate. The investigators are a cohesive, highly experienced multidisciplinary team from three well-established sites. By testing a novel intervention supported by multiple levels of evidence, the REHAB-HF trial will address a critical evidence gap in the care of older patients with ADHF, the most common Medicare discharge diagnosis. The REHAB-HF results could shift clinical management paradigms, improve function, reduce costs, and change health care policy for the 1 million older patients per year with hospitalized ADHF.