Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00012883 |
Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea and fatigue. Evaluating the effects of complementary intervention (such as exercise training) on functional status and QOL are clinically important and relevant to HF patients. In the last decade, hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic balance. These programs may be costly for patients to perform. Improved peak VO2 may not necessarily translate into improved functional status and quality of life. To date, the effects of a home walking exercise program alone on functional status, QOL and autonomic tone has not been evaluated.
Condition | Intervention |
---|---|
Heart Failure Functional Status Quality of Life |
Behavioral: Homewalking exercise program |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Home Walking Exercise Training in Advanced Heart Failure |
Estimated Enrollment: | 110 |
Study Completion Date: | December 2001 |
Arms | Assigned Interventions |
---|---|
1 | Behavioral: Homewalking exercise program |
Background:
Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea and fatigue. Evaluating the effects of complementary intervention (such as exercise training) on functional status and QOL are clinically important and relevant to HF patients. In the last decade, hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic balance. These programs may be costly for patients to perform. Improved peak VO2 may not necessarily translate into improved functional status and quality of life. To date, the effects of a home walking exercise program alone on functional status, QOL and autonomic tone has not been evaluated.
Objectives:
The specific aim was to compare functional status (FS), quality of life (QOL) and autonomic tone in 2 groups of advanced HF patients (nurse-managed home walking exercise (HWE) group vs. control group).
Methods:
A randomized controlled trial comparing a 12-week nurse-managed progressive HWE protocol to usual activity was conducted in 79 HF patients (78[99%] male; mean age 62.6 � 10.6 years; EF 27 � 8.8%; 63 [80%] NYHA II, 15[20%] NYHA III-IV; HF duration 39.2 � 41.8 months) from a VA medical center and a university affiliated medical center. 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 60 minutes. Pre- and post-study measures were FS (peak VO2 and ventilatory threshold via CPX, 6-minute walk test (6MWT) and a Heart Failure Functional Status Inventory (HFFSI)), QOL (Cardiac Quality of life Index (C-QLI), SF-36, and Dyspnea-Fatigue Index (DFI) with global rating of symptoms), and autonomic tone (norepinephrine (NE) and heart rate variability (HRV)). Intention-to-treat analysis with repeated measures ANOVA was used to identify group differences.
Status:
Completed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Should have a stable heart failure in the past 3 months (Max Age is 80)
Exclusion Criteria:
United States, California | |
VA Greater Los Angeles Health Care System | |
West Los Angeles, California, United States, 90073 |
Principal Investigator: | Teresita E. Corvera, RN MN PhD | VA Greater Los Angeles Health Care System |
Responsible Party: | Department of Veterans Affairs ( Corvera, Teresita - Principal Investigator ) |
Study ID Numbers: | NRI 96-031 |
Study First Received: | March 14, 2001 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00012883 History of Changes |
Health Authority: | United States: Federal Government |
Heart Failure Heart Diseases Quality of Life |
Heart Failure Heart Diseases Cardiovascular Diseases |