NCT Number: NCT00000523
Optimal Exercise Regimens for Persons at Increased Risk
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
50 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Nih
Registry information
Important dates
- Study start
- 1986
- First posted
- Oct 28, 1999
- Registry last updated
- Jun 24, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Sapphire 3 CTO Study
NCT06358508
Arterial Occlusive Diseases, Arteriosclerosis
Stanford, California, United States
View Trial DetailsDual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)
NCT04624854
Acute Coronary Syndrome, Arterial Occlusive Diseases
Chongqing, Chongqing Municipality, China
View Trial DetailsMulticenter Study of Silent Myocardial Ischemia (MSSMI)
NCT00005216
Angina Pectoris, Angina, Unstable
View Trial DetailsAmmonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)
NCT04343209
Arterial Occlusive Diseases, Arteriosclerosis
Miami, Florida, United States
View Trial Details