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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Behavioral: Exercise Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Actual Study Completion Date : March 2000

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Arm 1 Behavioral: Exercise




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

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


Locations
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00013221     History of Changes
Other Study ID Numbers: NRI 95-213
First Posted: March 16, 2001    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: February 2007

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases