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Clinical Trials/NCT00013221
NCT00013221
Completed
Phase 4

Exercise Effect on Aerobic Capacity and QOL in Heart Failure

US Department of Veterans Affairs1 site in 1 country84 target enrollmentMarch 16, 2001

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Heart Failure, Congestive
Sponsor
US Department of Veterans Affairs
Enrollment
84
Locations
1
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function. Until recently, the prescription for individuals with HF was rest and minimization of physical exertion.

Detailed Description

Background: Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function. Until recently, the prescription for individuals with HF was rest and minimization of physical exertion. Objectives: The primary objectives of this randomized clinical trial were to determine whether subjects, with moderate to severe chronic HF, who completed a 12-week individualized program of cardiopulmonary training (exercise group) would have significantly greater (i) quality of life, measured by the Rand Short Form-36, and (ii) aerobic fitness, measured by oxygen uptake during symptom limited maximal metabolic treadmill testing, than subjects who met weekly with an investigator and received vital sign measurements (non-exercise group). Methods: A randomized controlled clinical trial was utilized. Individuals who met the inclusion criteria were randomly assigned to either an exercise or control group. Individuals in the exercise group received 36 weeks of exercise training (primary outcome variables were measured at 12 weeks). Participants in the control group received weekly visits with a nurse for 12 weeks. Status: Ongoing data analysis for publication. Final report submitted.

Registry
clinicaltrials.gov
Start Date
March 16, 2001
End Date
March 2000
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Left ventricular ejection fraction less than or equal to 40%. Stable heart failure.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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