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

Not Applicable

Terminated

• Conditions: Heart Failure

• Registration Number: NCT02179242
• Lead Sponsor: Sanford Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-01
• Study Start: 2014-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test	30 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanford Heart Hospital; 🇺🇸 Sioux Falls, South Dakota, United States