Heart Failure Clinical Trial
Official title:
An Intervention to Enhance Function in Severe Cardiopulmonary Illness
Verified date | August 2017 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a randomized trial of a cardiopulmonary self-management intervention to improve functional capacity, health-related quality of life, and to reduce health care utilization. Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over four years. Outcomes will be measured at three points: at entry, at the end of the 6 month intervention, and 12 months after entry. Change in functional capacity at the end of the intervention program is the primary outcome.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - standard criteria for severe COPD or HF, - optimal medical management, - willingness to participate in an outpatient exercise/self-management program, - working phone, - hospitalization for HF, COPD, or related illness in the past two years or at least two unscheduled outpatient visits for same over the past year Exclusion Criteria: - unstable disease or recent surgery, - supplemental oxygen requirement at rest more than 4 LPM, - already participating in regular exercise three times a week, - inability to ambulate, - uncontrolled mental illness, - alcohol or drug abuse, - life expectancy less than one year |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Dougherty CM, Steele BG, Hunziker J. Testing an intervention to improve functional capability in advanced cardiopulmonary illness. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):35-41. doi: 10.1097/HCR.0b013e3181f1fd77. — View Citation
Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. Epub 2009 Sep 1. — View Citation
Steele BG, Belza B, Cain K, Coppersmith J, Howard J, Lakshminarayan S, Haselkorn J. The impact of chronic obstructive pulmonary disease exacerbation on pulmonary rehabilitation participation and functional outcomes. J Cardiopulm Rehabil Prev. 2010 Jan-Feb;30(1):53-60. doi: 10.1097/HCR.0b013e3181c85845. — View Citation
Steele BG, Belza B, Cain KC, Coppersmith J, Lakshminarayan S, Howard J, Haselkorn JK. A randomized clinical trial of an activity and exercise adherence intervention in chronic pulmonary disease. Arch Phys Med Rehabil. 2008 Mar;89(3):404-12. doi: 10.1016/j.apmr.2007.11.003. — View Citation
Steele BG, Cain K, Coppersmith J, Belza B, Howard J, Lakshminarayan S. Pulmonary rehabilitation (PR) outcomes in chronic obstructive pulmonary disease (COPD): Are benefits equivalent in end-stage disease? Proceedings of the American Thoracic Society. 2008 May 17; 177:A446.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Function Capability | 6MWT-Six Minute Walk Test | 6 months | |
Secondary | Quality of Life | SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores. | 6 months |
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