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Training Levels Comparison Trial

This study has been withdrawn prior to enrollment.
(due to lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000460
First Posted: October 28, 1999
Last Update Posted: January 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Alabama at Birmingham
  Purpose
To determine the effects of high or low intensity long-term exercise conditioning in patients with coronary artery disease.

Condition Intervention Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Behavioral: Low intensity exercise Behavioral: High intensity exercise Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Training Levels Comparison (TLC) Trial in Patients With Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Enrollment: 0
Study Start Date: December 1986
Study Completion Date: March 1991
Primary Completion Date: March 1991 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Low intensity exercise Behavioral: Low intensity exercise
High intensity exercise Behavioral: High intensity exercise

Detailed Description:

BACKGROUND:

A vast amount of literature exists on the improvements in work capacity, reduction of risk factors, and an increased feeling of well-being among coronary heart disease patients after physical training programs. Previous observations of short-term training programs which resulted in an increase in physical working capacity have not usually shown a cardiac change. The National Exercise and Heart Disease Project did not show such changes, but the exercise level may have been inadequate. Several other studies suggested that more prolonged and intense training could result in improved cardiac function.

DESIGN NARRATIVE:

Patients were randomized to high intensity or low intensity long-term exercise groups. Compliance was strengthened by randomizing following a sequence of eligibility visits and after a test period of subject reaction to an exercise program. The primary endpoint was change in exercise ejection fraction at one year. Secondary endpoints included changes in lipid levels, body composition, blood pressure and heart rate measurements, glucose tolerance, quality of life measures, compliance, and progression of disease. Patients were classified into one of four strata based on the documented history of myocardial infarction and resting left ventricular ejection fraction. Within each stratum, patients were assigned in equal numbers to the two intensity levels of exercise intervention. All exercise prescriptions were based on exercise testing of patients maintained on their usual medical regimen including drugs. Patients underwent standardized multistage treadmill exercise testing monitored by Doppler echocardiogram at baseline, just prior to randomization and at the three month, six month, one year and two year visits. Patients participated in the structured group exercise sessions three days per week. Each exercise session was preceded by and ended with a five to fifteen minute warm-up and cool-down session. Each patient was given an exercise prescription that included a 30 minute period of walking or of walking and jogging sequences and 15 minutes of arm-leg bicycle ergometer exercise. Recruitment started in May 1987. The last patient was enrolled in March 1990.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men between the ages of 30 and 67 who respond to an advertisement for research participants.
Criteria
Men, ages 30 to 67, with documented coronary heart disease.
  Contacts and Locations
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): NCT00000460


Sponsors and Collaborators
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Albert Oberman University of Alabama at Birmingham