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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,331
Exercise 30 minutes minimum three times per week.
Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3)
Time frame: Measured as events occur during the lifespan of the trial.
Changes in peak VO2
Time frame: Measured at 3 months, 12 months, and 24 months.
Changes in VE/VCO2 slope
Time frame: Measured at 3 months, 12 months, and 24 months.
Heart rate at a submaximal work load defined as the end of the exercise test's second stage
Time frame: Measured at 3 months, 12 months, and 24 months.
Changes in 6-minute walk (measured at Month 3 and Year 1)
Time frame: Measured at 3 months, 12 months, 24 months, 36 months, and at end of study.
Composite of cardiovascular mortality and cardiovascular hospitalization rates
Time frame: Measured as events occur during the life of the trial.
Composite of cardiovascular mortality and CHF hospitalization rates
Time frame: Measured as events occur during the life of the trial.
All-cause mortality rates
Time frame: Measured as events occur during the life of the trial.
Cardiovascular mortality rates
Time frame: Measured as events occur during the life of the trial.
All-cause hospitalization rates
Time frame: Measured as events occur during the life of the trial.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Heart Clinic Arkansas
Little Rock, Arkansas, United States
Memorial Heart Institute
Long Beach, California, United States
Ahmanson-University of California Los Angeles
Los Angeles, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
University of California at San Diego Medical Center
San Diego, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Heart and Vascular Clinic of Northern Colorado
Fort Collins, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States
...and 70 more locations
CHF hospitalization rates
Time frame: Measured as events occur during the life of the trial.
Heart attack rates
Time frame: Measured as events occur during the life of the trial.
Worsening CHF event rates
Time frame: Measured as events occur during the life of the trial.
Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates
Time frame: Measured as events occur during the life of the trial.
Cost
Time frame: Measured throughout the life of the trial.
Quality of life
Time frame: Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study