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Home > "H" Clinical Trials Conditions > Home Walking Exercise Training in Advanced Heart Failure  Home Walking Exercise Training in Advanced Heart Failure
Home Walking Exercise Training in Advanced Heart Failure
For Condition: Cardiomyopathy, Congestive
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service
Synopsis: Heart failure (HF) is a major public health burden in the United States. Despite considerable advances in the diagnosis and management of HF, it remains one of the leading causes of morbidity and mortality. HF is a progressive cardiovascular syndrome characterized by a reduction in exercise capacity with distressing symptoms of exertional fatigue and dyspnea. Currently, much of HF therapy is aimed at increasing survival. Yet, for many patients prolonged survival may be less critical than improved functional status and quality of life.38,39 Hence, a nursing intervention designed to ameliorate symptoms, maximize functional status, and achieve a high level of well-being is clinically relevant. Investigators have suggested that either a cardiac rehabilitation program or a home bicycle exercise training program may improve peak oxygen consumption, symptom scores and reverse autonomic imbalance. Improvement of peak oxygen consumption may not necessarily translate into improve functional status and quality of life. A cardiac rehabilitation program or bicycle ergometer may be costly for patients to perform. Utilizing a 2-group pre-test-post-test experimental design, the specific aim is to compare functional status (FS), quality of life (QOL) and neurohormonal activation in 2 groups of advanced HF patients (control group vs. home walking exercise (HWE) group). Will a 12-week HWE program decrease sympathetic activity, increase FS, and/or improve QOL? Heart failure patients from WLA-VAMC who meets inclusion criteria (dilated cardiomyopathy for 3 months, LVEF < 40%, NYHA Class II-III, 25-80 years) and exclusion criteria (i.e. MI or recurrent angina in past 3 months, orthopedic impediments, severe COPD, stenotic valvular disease, ventricular tachyarrhythmias, etc) are considered. Sample size will be 55 in each group. Consented patients are stratified by age: younger (< 60 years) and older (> 60 years); then, randomized into either control or experimental group. Control group performs "limited physical activity" for 12weeks; whereas, experimental group performs a 12-week HWE program. The 12- week HWE program is once a day, 5x a week and initiated at 10 minutes and progressively increases in duration and intensity up to 45 minutes. Pre- and post-study measures are sympathetic activation (norepinephrine (NE)), FS (peak VO2 via cardiopulmonary exercise test and a Heart Failure Functional Status Inventory), and QOL (Cardiac Quality of life Index by Ferrans and Powers, and the Dyspnea-Fatigue Rating Index). Between group differences over time for FS (VO2max, and HFFSI scores), QOL (C-QLI and Dyspnea-Fatigue Rating Index scores), neurohormonal activation (NE levels) will be evaluated by repeated measures multivariate analysis of variance. Significance will be set at alpha=.05.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Should have a stable heart failure in the past 3 months (Max Age is 80)
Total Enrollment: 110
Location and Contact Information:
VA Greater Los Angeles Healtcare System
Los Angeles, California, 90073
United States
Additional Information:
Study ID Numbers: NRI 96-031;
Study Start Date: October 1997
Record last reviewed: November 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012883
Other Cardiomyopathy, Congestive Studies:
1. Home Walking Exercise Training in Advanced Heart Failure
Related Studies:
Other Cardiomyopathy, Congestive Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Home Walking Exercise Training in Advanced Heart Failure
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