Rehabilitation and Exercise Training After Hospitalization

Study Overview
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Brief Summary
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Rehabilitation and Exercise Training after Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) pilot is a multi-site, randomized clinical pilot study designed to establish the feasibility of conducting a larger clinical trial to address the hypothesis that, in addition to standard care, a novel, progressive, multi-domain 3-month rehabilitation intervention administered to elderly patients with acute decompensated heart failure (ADHF) will improve key clinical outcomes, including the rate of rehospitalization and death, physical function, and quality of life.

Detailed Description
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Three centers,Wake Forest Baptist Health along with Thomas Jefferson University Hospital-Co-Investigator Dr. David Whellan, and Duke Medical Center- Co-Investigator Dr. Christopher O'Connor, will recruit a total of 60 consenting patients ≥ 60 years old hospitalized with ADHF. Once identified and screened, the participants will be randomized in a 1:1 fashion to receive a 3 month novel rehabilitation and exercise training intervention or usual care. This multi-domain intervention will include endurance, mobility, strength, and balance training and be tailored based on participant performance in each of these domains. It will begin during the hospitalization and continue three times per week in an outpatient facility.

Official Title
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Rehabilitation and Exercise Training After Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) Pilot Study

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Usual care
* Behavioral: Rehabilitation intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years old Hospitalized for the management of ADHF or diagnosed with ADHF after being hospitalized for another reason. ADHF will be defined as a combination of symptoms, signs, and HF-specific medical treatments. Exclusion Criteria: Planned discharge other than to home or a facility where the participant will live independently. Acute myocardial infarction Already participating in cardiac rehabilitation

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No intervention<br>Usual care control group | Behavioral: Usual care<br>* Usual care control group<br>|
| Active Comparator: Active Comparator<br>Multi domain rehabilitation intervention | Behavioral: Rehabilitation intervention<br>* Multi-domain rehabilitation intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk Test | The 6 minute walk test submaximal exercise test that measures how far a participant can walk in 6 continuous minutes. Participants are instructed to walk as far as possible in 6 minutes, and are allowed to slow down and take breaks as needed due to symptoms. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPPB (Short Physical Performance Battery) | The SPPB is a multi-component measure of physical function. The SPPB is composed of 3 components-standing balance, gait speed, and timed repeated chair rise-each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. A higher score denotes better physical function. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure