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Clinical Trials/NCT00012883
NCT00012883
Completed
N/A

Home Walking Exercise Training in Advanced Heart Failure

US Department of Veterans Affairs1 site in 1 country110 target enrollmentMarch 16, 2001

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
US Department of Veterans Affairs
Enrollment
110
Locations
1
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 16, 2001
End Date
December 2001
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Should have a stable heart failure in the past 3 months (Max Age is 80)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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