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

Sponsor

Sanford Health (Other)

Overall Status

Terminated

CT.gov ID

NCT02179242

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Cardiac rehab	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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.

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Control arm

This arm will receive routine care following their heart failure which includes no cardiac rehab intervention.

Experimental: Cardiac rehab

This arm will receive cardiac rehab intervention 3 times per week for 4 weeks following discharge.

Other: Cardiac rehab

Outcome Measures

Primary Outcome Measures

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

Readmission [30 days]
Determine if 30-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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