A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

Not Applicable

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Behavioral: Attention Control; Behavioral: multi-domain rehabilitation intervention

• Registration Number: NCT02196038
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Study Start: 2014-09
• Primary Completion: 2020-06-15
• Study Completion: 2020-07-27
• Status Verified: 2020-09
• Results First Submitted: 2021-05-28
• Results First Submitted QC: 2021-05-28
• Last Update Submitted: 2021-06-22
• Results First Posted: 2021-06-23
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control	Attention Control	Usual care group with bi-weekly contact from study staff
multi-domain rehabilitation intervention	multi-domain rehabilitation intervention	Individual, tailored, progressive, physical function rehabilitation intervention

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB) at Month 3	Month 3	The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.

Secondary Outcome Measures

Name	Time	Method
All-Cause Rehospitalization	Month 6	Number of all-cause rehospitalizations 6 months from index hospital discharge.

Trial Locations

Locations (3)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Thomas Jefferson University and Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States