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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00013221 |
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.
Condition | Intervention | Phase |
---|---|---|
Heart Failure, Congestive |
Behavioral: Exercise |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Factorial Assignment, Safety Study |
Official Title: | Exercise Effect on Aerobic Capacity and QOL in Heart Failure |
Estimated Enrollment: | 84 |
Study Completion Date: | March 2000 |
Arms | Assigned Interventions |
---|---|
1 | Behavioral: Exercise |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Left ventricular ejection fraction less than or equal to 40%. Stable heart failure.
Exclusion Criteria:
United States, Illinois | |
Edward Hines, Jr. VA Hospital | |
Hines, Illinois, United States, 60141-5000 |
Principal Investigator: | Eileen G. Collins, PhD RN | Edward Hines Jr. VA Hospital |
Responsible Party: | Department of Veterans Affairs ( Collins, Eileen - Principal Investigator ) |
Study ID Numbers: | NRI 95-213 |
Study First Received: | March 14, 2001 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00013221 History of Changes |
Health Authority: | United States: Federal Government |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |