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

Wake Forest University (WFU)

Status: Completed

Conditions: Acute Decompensated Heart Failure

Treatments: Behavioral: multi-domain rehabilitation intervention; Behavioral: Attention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02196038

R01AG045551 (U.S. NIH Grant/Contract)

IRB00028221

Details and patient eligibility

About

REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a multicenter, randomized, attention-controlled, single-blind trial designed to examine the hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will improve physical function and key clinical outcomes, including the rate of rehospitalization.

Full description

There will be three lead centers, Wake Forest Baptist Health along with Thomas Jefferson University and Hospital-Co-Investigator Dr. David Whellan, and Duke University Medical Center-Co-Investigator Dr. Christopher O'Connor. Each center may recruit up to 3 geographically close, tightly affiliated 'satellite' sites under their management and budgetary control. Together, these sites will recruit a total of 352 consenting patients ≥ 60 years old hospitalized with ADHF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 12-week novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The multi-domain rehabilitation intervention will include endurance, mobility, strength, and balance training and will be tailored based on participant performance in each of these domains. It will begin upon randomization during the hospitalization and will continue 3 times per week in an outpatient setting. Participants randomized to the attention control arm will receive all services ordered by their primary physician and will be contacted bi-weekly by study staff. All participants will undergo measures of physical function and quality of life at baseline, 1 month, and 3 months. Clinical events will be monitored for 6 months following the index hospitalization.

Enrollment: 349 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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349 participants in 2 patient groups

Attention Control

Other group

Description:

Usual care group with bi-weekly contact from study staff

Treatment:

Behavioral: Attention Control

multi-domain rehabilitation intervention

Active Comparator group

Description:

Individual, tailored, progressive, physical function rehabilitation intervention

Treatment:

Behavioral: multi-domain rehabilitation intervention