Cardiovascular Diseases Clinical Trial
Official title:
Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).
BACKGROUND:
CHF affects approximately five million Americans and is the number one cause of hospital
admission in individuals over the age of 65. Although exercise training improves several
clinical measures in individuals with CHF (e.g., peak VO2, heart rate variability, and
plasma norepinephrine levels), it is not known whether exercise training reduces mortality
in individuals with CHF.
DESIGN NARRATIVE:
This multicenter randomized study will determine if exercise training reduces mortality and
hospitalization rates in individuals with moderate to severe CHF. The secondary objective is
to evaluate whether an exercise program designed for individuals with CHF improves quality
of life and functioning, is economically advantageous, and prevents medical complications.
Three thousand individuals with moderate to severe CHF will be randomly assigned to either
standard medical therapy and education, or standard medical therapy and education plus a
supervised exercise training program. The exercise training will include 36 supervised
clinic-based training sessions followed by home-based exercise and periodic supervised
sessions for reinforcement. Participants assigned to the supervised exercise training
program will use either a treadmill or stationary bicycle, which will be provided for them.
Recruitment Status: As of November 9, 2006, HF-ACTION has enrolled 2180 subjects and will
conclude enrollment at the end of February, 2007, with an anticipated enrollment of
approximately 2300 subjects.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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