Heart Failure Clinical Trial
Official title:
Home Walking Exercise Training in Advanced Heart Failure
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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