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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG078153 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause rehospitalizations and mortality and the secondary outcome of major mobility disability during 6-month follow-up in patients hospitalized for heart failure and preserved ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.
REHAB-HFpEF, is a multicenter, randomized, attention-controlled, single-blind trial to examine the hypothesis that, a novel, tailored, progressive, multi-domain physical rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) with preserved ejection fraction (HFpEF) beginning early during hospitalization and continuing for 12 weeks in a structured outpatient setting, and continuing as a maintenance program will reduce the rate of combined all-cause rehospitalization and death at 6 months (the primary outcome), and reduce major mobility disability (MMD) prevalence at 6 months (the secondary outcome). This trial, REHAB-HFpEF, builds upon preliminary studies, including the phase 2 REHAB-HF trial, which suggests this intervention may yield significant benefits for this population which are largely older, frail, and with few evidence-based treatment options. Participants will be recruited from 20 clinical centers, each of which may have up to 3 tightly-affiliated 'satellite' sites geographically-close, under their direct management. Together, these centers will recruit a total of 880 consenting patients >=60 years old hospitalized with ADHF with HFpEF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks. Those randomized to the attention control will be contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations. Both arms will receive all services ordered by their primary physician (usual care) and undergo measures of physical function, cognitive function, and quality of life (QOL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation Intervention | Experimental | The Rehabilitation Intervention is a novel, progressive, multi-domain rehabilitation and exercise training intervention. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks. |
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| Attention Control | No Intervention | Attention control participants are contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation Intervention | Behavioral | progressive, multi-domain rehabilitation and exercise training intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Combined All-cause Rehospitalization and Death | Rate of combined all-cause rehospitalizations and death 6 months following discharge from index hospitalization. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of major mobility disability (MMD) | Percentage of participants with MMD, defined as the inability to walk 160 meters during a 6 minute walk test. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause rehospitalization | Exploratory outcome. Rate of rehospitalizations 6 months following discharge from index hospitalization. | Month 6 |
| All-cause death | Exploratory outcome. Rate of death 6 months following discharge from index hospitalization. |
Inclusion Criteria:
Age >=60 years old
Ejection Fraction >=45%
In the hospital setting >24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the site physician, and will be defined according to the Food and Drug Administration (FDA) definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments, and requires that all 4 of the following are met:
Adequate clinical stability to allow participation in study assessments and the intervention Independent with basic activities of daily living, including the ability to ambulate independently (with or without the use of an assistive device) prior to admission
Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Nelson, MS | Contact | 336-716-6789 | mbnelson@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dalane W Kitzman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41812966 | Derived | Pastva AM, Reeves GR, Whellan DJ, Mentz RJ, Chen H, Bertoni AG, Duncan PW, Espeland MA, Reed SD, Nelson MB, O'Connor CM, Kitzman DW; REHAB-HFpEF Trial Investigators. Physical rehabilitation for older patients with acute HFpEF (REHAB-HFpEF) trial: Design and rationale. Am Heart J. 2026 Jul;297:107420. doi: 10.1016/j.ahj.2026.107420. Epub 2026 Mar 10. |
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| Month 6 |
| Cardiovascular rehospitalization and death | Exploratory outcome. Rate of combined cardiovascular rehospitalizations and death 6 months following discharge from index hospitalization. | Month 6 |
| Short Physical Performance Battery (SPPB) | Exploratory outcome. The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function. | Month 6 |
| 6-minute Walk Distance (6MWD) | Exploratory outcome. Distance walked in 6 minutes. | Month 6 |
| Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Exploratory outcome. The KCCQ is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status. | Month 6 |