NCT00047437

Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure

Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,331 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).

Detailed description

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.

Conditions

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure, Congestive

Interventions

Type	Name	Description
BEHAVIORAL	Supervised Exercise Training Program	Exercise 30 minutes minimum three times per week.

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2002-10-04
• Last updated: 2013-03-21

Locations

80 sites across 3 countries: United States, Canada, France