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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac rehab
Sponsored by
Sanford Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring cardiac rehab, heart failure, KCCQ, 6 minute walk test, readmission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sanford Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Cardiac rehab

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2014
Last Updated
November 17, 2015
Sponsor
Sanford Health
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1. Study Identification

Unique Protocol Identification Number
NCT02179242
Brief Title
Study to Evaluate the Effectiveness of Cardiac Rehabilitation (Rehab) for Acute Decompensated Heart Failure Patients on 6 Minute Walk Test and Quality of Life
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Lower than expected accrual
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanford Health

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
cardiac rehab, heart failure, KCCQ, 6 minute walk test, readmission

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
This arm will receive routine care following their heart failure which includes no cardiac rehab intervention.
Arm Title
Cardiac rehab
Arm Type
Experimental
Arm Description
This arm will receive cardiac rehab intervention 3 times per week for 4 weeks following discharge.
Intervention Type
Other
Intervention Name(s)
Cardiac rehab
Primary Outcome Measure Information:
Title
6 Minute Walk Test
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Readmission
Description
Determine if 30-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care
Time Frame
30 days
Title
Readmission
Description
Determine if 90-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care
Time Frame
90 days
Title
KCCQ
Description
Assess if those receiving cardiac rehabilitation have improved quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) classifications at 30 days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orvar Jonsson, MD
Organizational Affiliation
Sanford Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford Heart Hospital
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20498608
Citation
Davidson PM, Cockburn J, Newton PJ, Webster JK, Betihavas V, Howes L, Owensby DO. Can a heart failure-specific cardiac rehabilitation program decrease hospitalizations and improve outcomes in high-risk patients? Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):393-402. doi: 10.1097/HJR.0b013e328334ea56.
Results Reference
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PubMed Identifier
23239837
Citation
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. No abstract available. Erratum In: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.
Results Reference
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PubMed Identifier
19919979
Citation
Guazzi M, Dickstein K, Vicenzi M, Arena R. Six-minute walk test and cardiopulmonary exercise testing in patients with chronic heart failure: a comparative analysis on clinical and prognostic insights. Circ Heart Fail. 2009 Nov;2(6):549-55. doi: 10.1161/CIRCHEARTFAILURE.109.881326. Epub 2009 Sep 28.
Results Reference
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PubMed Identifier
21262990
Citation
Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
Results Reference
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PubMed Identifier
24130003
Citation
Joseph SM, Novak E, Arnold SV, Jones PG, Khattak H, Platts AE, Davila-Roman VG, Mann DL, Spertus JA. Comparable performance of the Kansas City Cardiomyopathy Questionnaire in patients with heart failure with preserved and reduced ejection fraction. Circ Heart Fail. 2013 Nov;6(6):1139-46. doi: 10.1161/CIRCHEARTFAILURE.113.000359. Epub 2013 Oct 15.
Results Reference
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PubMed Identifier
24296380
Citation
Sauser K, Spertus JA, Pierchala L, Davis E, Pang PS. Quality of life assessment for acute heart failure patients from emergency department presentation through 30 days after discharge: a pilot study with the Kansas City Cardiomyopathy Questionnaire. J Card Fail. 2014 Jan;20(1):18-22. doi: 10.1016/j.cardfail.2013.11.010. Epub 2013 Dec 1. Erratum In: J Card Fail. 2014 May;20(5):278.
Results Reference
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PubMed Identifier
17643574
Citation
Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007 Aug;154(2):260-6. doi: 10.1016/j.ahj.2007.01.041.
Results Reference
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Study to Evaluate the Effectiveness of Cardiac Rehabilitation (Rehab) for Acute Decompensated Heart Failure Patients on 6 Minute Walk Test and Quality of Life

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