Exercise Effect on Aerobic Capacity and QOL in Heart Failure
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|ClinicalTrials.gov Identifier: NCT00013221|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Behavioral: Exercise||Phase 4|
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.
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).
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.
Ongoing data analysis for publication. Final report submitted.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise Effect on Aerobic Capacity and QOL in Heart Failure|
|Study Completion Date :||March 2000|
|Arm 1||Behavioral: Exercise|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013221
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL|
|Hines, Illinois, United States, 60141-5000|
|Principal Investigator:||Eileen G. Collins, PhD RN||Edward Hines Jr. VA Hospital, Hines, IL|
|Principal Investigator:||Walter Edwin Langbein, PhD||Edward Hines Jr. VA Hospital, Hines, IL|