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Trial NCT00000523

Resource URI: http://static.linkedct.org/resource/trials/NCT00000523
linkedct:brief_title Optimal Exercise Regimens for Persons at Increased Risk
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 50 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000523
rdfs:label Trial NCT00000523
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000523
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 42
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000523>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/36793>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date April 1986
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date January 2000