A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

Study Overview
=================
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.

Official Title
-----------------
REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

Conditions
-----------------
Acute Decompensated Heart Failure

Intervention / Treatment
-----------------
* Behavioral: multi-domain rehabilitation intervention
* Behavioral: Attention Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Attention Control<br>Usual care group with bi-weekly contact from study staff | Behavioral: Attention Control<br>* Usual care with bi-weekly contact from study staff<br>|
| Active Comparator: multi-domain rehabilitation intervention<br>Individual, tailored, progressive, physical function rehabilitation intervention | Behavioral: multi-domain rehabilitation intervention<br>* Individual, tailored, progressive physical function rehabilitation intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Rehospitalization | Number of all-cause rehospitalizations 6 months from index hospital discharge. | Month 6 | 

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