A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF)
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ClinicalTrials.gov Identifier: NCT02196038 |
Recruitment Status :
Completed
First Posted : July 21, 2014
Results First Posted : June 23, 2021
Last Update Posted : June 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Decompensated Heart Failure | Behavioral: multi-domain rehabilitation intervention Behavioral: Attention Control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 349 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | June 15, 2020 |
Actual Study Completion Date : | July 27, 2020 |

Arm | Intervention/treatment |
---|---|
Attention Control
Usual care group with bi-weekly contact from study staff
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Behavioral: Attention Control
Usual care with bi-weekly contact from study staff |
Active Comparator: multi-domain rehabilitation intervention
Individual, tailored, progressive, physical function rehabilitation intervention
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Behavioral: multi-domain rehabilitation intervention
Individual, tailored, progressive physical function rehabilitation intervention |
- Short Physical Performance Battery (SPPB) at Month 3 [ Time Frame: Month 3 ]The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.
- All-Cause Rehospitalization [ Time Frame: Month 6 ]Number of all-cause rehospitalizations 6 months from index hospital discharge.
- 6-minute Walk Distance [ Time Frame: Month 3 ]Exploratory outcome. Distance walked in 6 minutes.
- Handgrip Strength [ Time Frame: Month 3 ]Exploratory outcome. Handgrip strength is measured in kilograms by a handgrip dynamometer.
- Frailty Status (Fried Frailty Criteria) at Month 3 [ Time Frame: Month 3 ]Exploratory outcome. Frailty is assessed by the Fried criteria consisting of 5 components: low physical activity, exhaustion, weakness, slowness, and unintentional weight loss. Presence of 3 or more Fried criteria indicates frailty, 1-2 criteria indicates pre-frailty, and 0 criteria indicates no frailty.
- Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Month 3 ]Exploratory outcome. The KCCQ Overall Summary Summary Score 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.
- Physical Limitation as Assessed by the KCCQ Physical Limitation Score [ Time Frame: Month 3 ]Exploratory outcome. The Physical Limitation Score of the KCCQ questionnaire is a subscore evaluating disease-specific physical limitation. Scores range 0-100 with a higher score indicating less physical limitation.
- Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12) [ Time Frame: Month 3 ]Exploratory outcome. The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status.
- Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L) [ Time Frame: Month 6 ]Exploratory outcome. The EQ-5D-5L is a quality of life tool with 5 components designed to detect health utilities: mobility, usual activities, self-care, pain/discomfort, and anxiety/depression. All components are rated on a scale of 1-5 with higher scores indicating worse health status.
- Depression Measured by the Geriatric Depression Scale [ Time Frame: Month 3 ]Exploratory outcome. The Geriatric Depression Scale is a 15-item questionnaire evaluating depressive symptoms. Scores range from 0-15 with a higher score indicating more severe depressive symptoms.
- Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Month 3 ]Exploratory outcome. The Montreal Cognitive Assessment is a tool for assessing multiple domains of cognitive function. Scores range 0-30 with higher scores indicating better cognitive function. A score greater than or equal to 26 is considered normal cognitive function.
- All-cause Rehospitalizations at Month 1 [ Time Frame: Month 1 ]Exploratory outcome. Number of all-cause rehospitalizations 1 month post index hospitalization discharge.
- All-cause Rehospitalizations at Month 3 [ Time Frame: Month 3 ]Exploratory outcome. Number of all-cause rehospitalizations 3 months after discharged from index hospitalization
- All-cause Combined Rehospitalization and Death at Month 6 [ Time Frame: Month 6 ]Exploratory outcome. Combined number of all-cause rehospitalizations and death 6 months after discharge from index hospitalization
- Heart Failure Rehospitalizations at Month 6 [ Time Frame: Month 6 ]Exploratory outcome. Number of heart failure rehospitalizations 6 months after discharge from index hospitalization
- Hospitalization Days Post-randomization [ Time Frame: Month 6 ]Exploratory outcome. Total days spent hospitalized after date of randomization.
- Facility-free Days Alive [ Time Frame: Month 6 ]Exploratory outcomes. Total days alive spent outside of hospital, observation unit, acute rehab setting, and skilled nursing facility 6 months after discharge from index hospitalization.
- Emergency Department Visits [ Time Frame: Month 6 ]Exploratory outcomes. Number of emergency department visits after 6 months from hospital discharge
- Observation Unit Stays <24 Hours [ Time Frame: Month 6 ]Exploratory outcome. Number of observation unit stays <24 hours 6 months after discharge from index hospitalization
- Unscheduled Urgent Medical Visits [ Time Frame: Month 6 ]Exploratory outcome. Number of unscheduled urgent medical visits after discharge from index hospitalization
- Global Rank Score of Short Physical Performance Battery Score + All-cause Rehospitalization + Death [ Time Frame: Month 6 ]Exploratory outcome. The global rank composite outcome combines non-commensurate endpoints including death, number of all-cause rehospitalizations, and month 3 SPPB into a single non-parametric outcome in a hierarchical manner with death being ranked first and SPPB being ranked last. Participants are ranked from the most adverse response (lowest rank) to the most favorable response (highest rank).
- Placement at Skilled Nursing Facility [ Time Frame: Month 6 ]Exploratory outcome. Number of placements at skilled nursing facilities after discharge from index hospitalization.
- Physical Activity Assessed by Accelerometry [ Time Frame: Month 6 ]Exploratory outcome. Physical activity assessed by accelerometry quantified in moderate-vigorous physical activity minutes per day.
- Generalized Optimism Assessed by the Life Orientation Test-Revised [ Time Frame: Month 3 ]Exploratory outcome. The Life Orientation Test-Revised is a assessment of generalized optimism scored on a scale of 0-24 with higher scores indicating higher optimism.
- Economic Analysis [ Time Frame: Month 6 ]Assess direct medical costs, direct non-medical costs, indirect patient time costs, short-term cost-analysis, long-term cost analysis, and sustainability of the intervention.
- Biomarkers [ Time Frame: Month 3 ]Two well-accepted biomarkers of HF disease severity and prognosis, NT-proBNP and galectin-3, and increased biomarkers in older HF patients Tumor necrosis factor alpha, C-reactive protein, and interleukin-6.

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 60 years old
- In the hospital setting >24 hours for the management of ADHF, or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the study physician, and will be defined according to the Food and Drug Administration definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments.
Exclusion Criteria:
- Acute myocardial infarction
- Planned discharge other than to home or a facility where the participant will live independently
- Already actively participating in formal, facility-based cardiac rehabilitation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196038
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Wake Forest Baptist Health | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Pennsylvania | |
Thomas Jefferson University and Hospital | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Dalane W. Kitzman, MD | Wake Forest University Health Sciences |
Documents provided by Wake Forest University Health Sciences:
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT02196038 |
Other Study ID Numbers: |
IRB00028221 R01AG045551 ( U.S. NIH Grant/Contract ) |
First Posted: | July 21, 2014 Key Record Dates |
Results First Posted: | June 23, 2021 |
Last Update Posted: | June 24, 2021 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
heart failure |
Heart Failure Heart Diseases Cardiovascular Diseases |