Study to Evaluate the Effectiveness of Cardiac Rehabilitation (Rehab) for Acute Decompensated Heart Failure Patients on 6 Minute Walk Test and Quality of Life

Study Overview
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Brief Summary
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The aim of the investigators' project is to determine if patients admitted with a primary diagnosis of heart failure to Sanford Health facilities in regional southeastern South Dakota demonstrate benefits in improvement in functional capacity, quality of life, and a reduction in hospital readmission rates from a cardiac rehab program immediately following a discharge for an acute decompensated heart failure diagnosis related inpatient hospitalization encounter. The investigators hypothesize that those that receive cardiac rehab will have improved quality of life and reduced readmission rates at 30 and 90 days.

Official Title
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Randomized, Single Center Study to Determine if a Cardiac Rehabilitation Program Immediately Following Hospitalization Reduces Hospital Readmissions and Improves Quality of Life Outcomes in Heart Failure Patients.

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Cardiac rehab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Admitted with acute, decompensated heart failure Signed informed consent Exclusion Criteria: Approved by Center for Medicare and Medicaid Services (CMS) to enroll in cardiac rehab Have an elective procedure that would interrupt their exercise program Unable to partake in an exercise program due to physical incapacities Pregnancy Unable to read and understand the consent form

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>This arm will receive routine care following their heart failure which includes no cardiac rehab intervention. | |
| Experimental: Cardiac rehab<br>This arm will receive cardiac rehab intervention 3 times per week for 4 weeks following discharge. | Other: Cardiac rehab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk Test | Assess increased functional capacity, determined by the 6 minute walk test in the cardiac rehabilitation group compared to the routine care group at 4 weeks following hospital discharge | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Determine if 30-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care | 30 days | 
| Readmission | Determine if 90-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care | 90 days | 
| KCCQ | Assess if those receiving cardiac rehabilitation have improved quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) classifications at 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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6 minute walk test, cardiac rehab, heart failure, KCCQ, readmission