Optimal Exercise Regimens for Persons at Increased Risk

Phase 2

Completed

• Conditions: Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases

• Registration Number: NCT00000523
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

To assess exercise training adherence and compliance over two years in subjects who were at relatively high risk for coronary artery disease. Also, to test strategies for improving adherence and compliance and to assess the effect of exercise training.

Detailed Description

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.

Study Timeline

• Study Start: 1986-04
• Study First Submitted: 1999-10-27
• Study First Submitted QC: 1999-10-27
• Study First Posted: 1999-10-28
• Status Verified: 2000-01
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified