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Training Levels Comparison Trial

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What is being collected

Behavioral Data

+ behavioral Data
Collected from today forward - Prospective
Behavioral
Who is being recruted

Cardiovascular Diseases
+1

+ Coronary Disease
+ Heart Diseases
From 30 to 67 Years
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 1986

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 6, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 1986Actual date on which the first participant was enrolled.

To determine the effects of high or low intensity long-term exercise conditioning in patients with coronary artery disease. 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.

Official TitleTraining Levels Comparison (TLC) Trial in Patients With Coronary Heart Disease 
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 6, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
From 30 to 67 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Criteria

Men, ages 30 to 67, with documented coronary heart disease.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Group II

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

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