Acute Decompensated Heart Failure Clinical Trial
Official title:
REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
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.
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. ;
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