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

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02179242
• Other study ID #: SH Cardiac Rehab for HF
• Status: Terminated
• Phase: N/A
• First received: June 27, 2014
• Last updated: November 17, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Cardiac rehab

Locations

Country	Name	City	State
United States	Sanford Heart Hospital	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Joseph SM, Novak E, Arnold SV, Jones PG, Khattak H, Platts AE, Dávila-Román 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. — View 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. Corrected and republished in: J Card Fail. 2014 May;20(5):378.e11-5. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days	No
Secondary	Readmission	Determine if 30-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care	30 days	No
Secondary	Readmission	Determine if 90-day readmission rates are lower with those receiving cardiac rehabilitation compared to those receiving routine care	90 days	No
Secondary	KCCQ	Assess if those receiving cardiac rehabilitation have improved quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) classifications at 30 days	30 days	No