# Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF Trial

> **NIH NIH R01** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2024 · $6,876,637

## Abstract

Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older persons, and is
associated with marked physical disability, poor health-related quality of life (HRQOL), frequent
rehospitalizations, loss of independence, high mortality, and enormous health care costs. However, most of
the trials testing a wide range of medications and strategies in ADHF have been neutral. In our recently
completed NIA-funded phase 2 trial (REHAB-HF), an innovative, early, transitional, tailored, and progressive
multi-domain physical rehabilitation intervention produced a large improvement in the primary outcome of Short
Physical Performance Battery (+1.5 points) in older patients with ADHF. At baseline, the participants (53%)
with HF with preserved ejection fraction (HFpEF), had significantly worse impairments in physical function,
frailty, HRQOL, and depression than those with HF with reduced EF. They also appeared to derive greater
benefit from the intervention, with ~50% larger effect sizes in physical function, frailty, HRQOL, and
depression. Patients with HFpEF also appeared to have much greater reductions in rehospitalizations and
death and potential for reduced medical resource use. The finding of potentially greater benefit in HFpEF is
noteworthy as HFpEF is highly relevant to older persons and has the most urgent need for new treatments
since it is: 1) the most common form of HF, nearly unique to older persons, and disproportionately affects older
women and Black persons; 2) increasing in prevalence; 3) accepted as a geriatric syndrome; 4) associated
with marked impairments in physical function and HRQOL and high rates of frailty; 5) has high morbidity and
mortality which are worsening over time; and 6) has limited evidence-based treatments. The phase 3 REHAB-
HFpEF trial will focus on this large, growing, vulnerable, underserved population. The 5-year, randomized,
attention-controlled, single-blinded trial will enroll 880 older adults age >60 years with ADHF and HFpEF
across 20 geographically dispersed clinical centers. We will test the hypothesis that the innovative REHAB-HF
intervention will improve the clinically compelling combined primary endpoint of all-cause rehospitalizations and
mortality during 6-month follow-up, the most vulnerable time period following ADHF hospitalization (Aim 1) and
the secondary endpoint of prevalence of major mobility disability, a clinically meaningful outcome in trials of
older adults, at 6-months (Aim 2). We will also assess the intervention’s impact on HRQOL, frailty, depression,
physical activity, and health care costs. Our diverse, cohesive, multi-disciplinary team and experience from the
phase 2 trial will ensure efficient and effective execution and dissemination. REHAB-HFpEF directly addresses
the key recommendations of several recent NIA and NHLBI sponsored workshops. Its results could improve
key outcomes that are meaningful to patients, caregivers, health systems, and payers. The tria...

## Key facts

- **NIH application ID:** 10911158
- **Project number:** 5R01AG078153-03
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** DALANE W KITZMAN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $6,876,637
- **Award type:** 5
- **Project period:** 2022-08-15 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10911158

## Citation

> US National Institutes of Health, RePORTER application 10911158, Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF Trial (5R01AG078153-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10911158. Licensed CC0.

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