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

November 17, 2015 updated by: Sanford Health

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute Walk Test
Time Frame: 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
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Investigators

  • Principal Investigator: Orvar Jonsson, MD, Sanford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH Cardiac Rehab for HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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