Completed

Optimal Exercise Regimens for Persons at Increased Risk

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What is being tested

Data Collection

Who is being recruted

Cardiovascular Diseases
+2

+ Coronary Disease
+ Heart Diseases
From 50 to 65 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: April 1986
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 1986Actual date on which the first participant was enrolled.

BACKGROUND: Regular physical exercise is associated with lower coronary heart disease mortality, favorably affects coronary risk factors, and increases cardiovascular functional capacity. Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so. This is largely because effective strategies for increasing the exercise habit in a broadly-based segment of Americans have not been developed. This study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting. DESIGN NARRATIVE: Following stratification by gender and cigarette smoking status, subjects were randomized to one of four groups: home exercise of moderate intensity which was individually monitored; home exercise of high intensity which was individually monitored; exercise of high intensity which was group supervised; and a no program control group. The intervention program was conducted for one year followed by a one-year maintenance program. Main outcome measures included treadmill exercise test performance, exercise participation rates, and heart disease risk factors. Variables measured over two years included plasma lipids, lipoproteins, apoproteins, lipase activity, glucose and insulin, sex hormones, cardiovascular reactivity to psychological stress, cigarette smoking, nutrient intake, psychological status, and cardiovascular functional capacity.

Official TitleOptimal Exercise Regimens for Persons at Increased Risk 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: January 18, 2026
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.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 50 to 65 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
Vascular Diseases
Myocardial Ischemia
Criteria

Sedentary men and women, ages 50 to 65. Women were postmenopausal and not taking hormone replacement therapy. All subjects were free from, but at increased risk for, coronary heart disease.



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. 

CompletedNo study centers
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