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

描述（由申请人提供）：急性失代偿性心力衰竭（ADHF）是老年人住院的主要原因，显著恶化生活质量，增加死亡率和医疗保健费用，并已被CMS宣布为国家优先事项。 然而，目前的管理策略对ADHF再住院的影响不大，最近的试验结果是负面的，这表明需要一种新的方法。 多方面证据表明，身体功能的严重损害是老年ADHF患者不良结局的重要原因。 即使病情稳定且代偿良好，老年慢性HF患者的身体功能也会严重受损，当他们转变为ADHF时，身体功能会明显恶化。住院相关因素，包括被迫卧床休息，进一步加剧了这些问题。 出院后，患者在力量、平衡、活动性和耐力方面仍有明显的障碍。大多数患者符合虚弱的正式定义，有些患者从未恢复基线功能。这发生在早期再住院和不良结局的最高风险期。 我们推测，这一系列事件导致持续的严重身体功能障碍，导致老年HF患者的高再住院率。然而，目前的HF管理模式并没有解决身体功能的显著损害，慢性或急性HF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，力量和移动性领域，这些领域对于预防虚弱，老年患者的伤害很重要。 为了解决这一关键的证据缺口，我们开发了一种新的，定制的，渐进的，多学科的12周康复干预，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，这种干预是安全的，并产生了17.9%的改善，在短期物理性能电池（SPPB）评分和29.3%的减少全因再住院。SPPB评分的变化解释了90%的全因再住院减少。拟议研究（REHAB-HF）的主要目的是在360例老年ADHF患者中进行一项多中心、随机、对照、单盲试验，以检验主要特定假设，即REHAB-HF干预将改善SPPB测量的身体功能。次要目的是在6个月随访期间收集临床结局数据，以检验REHAB-HF干预组6个月全因再住院率降低的假设。 研究者是来自三个成熟研究中心的具有凝聚力、经验丰富的多学科团队。通过测试一种由多层次证据支持的新型干预措施，REHAB-HF试验将解决老年ADHF患者护理中的关键证据缺口，ADHF是最常见的医疗保险出院诊断。REHAB-HF结果可能会改变临床管理模式，改善功能，降低成本，并改变每年100万老年ADHF住院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.