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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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ClinicalTrials.gov Identifier: NCT02179242
Recruitment Status : Terminated (Lower than expected accrual)
First Posted : July 1, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Cardiac rehab Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Readmission [ Time Frame: 30 days ]
    Determine if 30-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care

  2. Readmission [ Time Frame: 90 days ]
    Determine if 90-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179242


Locations
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United States, South Dakota
Sanford Heart Hospital
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Sanford Health
Investigators
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Principal Investigator: Orvar Jonsson, MD Sanford Health

Publications:
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. Review. Erratum in: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.
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.

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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT02179242     History of Changes
Other Study ID Numbers: SH Cardiac Rehab for HF
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Sanford Health:
cardiac rehab
heart failure
KCCQ
6 minute walk test
readmission
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases