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

REHAB-HF：老年急性心力衰竭患者康复治疗的试验

基本信息

批准号：
9041481
负责人：
DALANE W KITZMAN
金额：
$ 142.23万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-06-01 至 2019-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9041481
关键词：
Acute Address Admission activity Adverse event Aging Attention Bed rest Cardiac rehabilitation Cardiovascular system Caring Cessation of life Chronic Clinical Clinical Management Clinical Trials Complement Consensus Control Groups Cost Analysis Data Deterioration Diagnosis Disease Elderly Equilibrium Event Exercise Fatigue Functional disorder Health Health Care Costs Health Policy Heart failure Hospitalization Hospitals Impairment Injury Intervention Level of Evidence Measures Medical Medicare Outcome Patient Discharge Patients Persons Physical Function Physical Performance Pilot Projects Quality of life Randomized Rehabilitation therapy Research Personnel Resolution Shortness of Breath Single-Blind Study Site Skeletal Muscle Symptoms Testing Walking adverse outcome arm cost design economic impact exercise program exercise training experience follow-up forest frailty group intervention high risk improved improved functioning indexing intervention effect meetings mortality multidisciplinary novel novel strategies older patient prevent public health relevance single-blind trial

项目摘要

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.

描述（由申请人提供）：急性代偿性心力衰竭（ADHF）是老年人住院的主要原因，这显着恶化了生活质量，增加了死亡率和医疗保健费用，并且已被CMS宣布为国家优先事项。但是，当前的管理策略对ADHF的再住院作用只有适度的影响，最近的试验是负面的，这表明需要采用新方法。多种证据表明，身体功能的严重损害会严重导致老年ADHF患者的不良结果。即使在稳定且补偿良好的情况下，患有慢性HF的老年患者的身体功能也有严重损害，在过渡到ADHF时，它们显着恶化。与医院相关的因素，包括强迫床休息，这些因素进一步加剧了这些因素。出院后，患者的强度，平衡，活动能力和耐力都显着损害。大多数患者符合脆弱的正式定义，有些人永远不会恢复基线功能。这发生在早期再住院和不良后果的最高风险期间。我们假设，这一系列事件导致持续，严重的身体功能障碍有助于老年HF患者的高温疗程率。但是，当前的HF管理范例不能解决身体机能的明显障碍，并且慢性和急性HF均未批准心脏康复的指示。此外，运动训练试验排除了ADHF，还不包括平衡，力量和流动性的领域，这对于预防脆弱的老年患者受伤很重要。为了解决这个关键的证据差距，我们开发了一种新颖的，量身定制的，进行的，多学科的12周康复干预措施，旨在解决老年ADHF患者身体机能的特定缺陷。在我们的试点研究中，这种干预措施是安全的，并且在短体性能电池（SPPB）得分（SPPB）得分和全因重新寄养方法的降低29.3％。 SPPB分数的变化解释了全因重新建立的减少的90％。拟议研究的主要目的（REHHAB-HF）是在360名ADHF患者中进行多中心，随机，受控的单盲试验，以检验主要的特定假设，即通过SPPB测量，REHHAB-HF干预将改善身体功能。次要目的是在6个月的随访期间收集临床结果数据，以检验康复HF干预组将降低6个月的全原因再住院率的假设。调查人员是来自三个良好站点的凝聚力，经验丰富的多学科团队。通过测试由多个证据支持的新型干预措施，Rehab-HF试验将解决对老年ADHF患者（最常见的Medicare出院诊断）的关键证据差距。 REHAB-HF结果可能会改变临床管理范例，提高功能，降低成本并改变住院ADHF的100万老年患者的医疗保健政策。