Status:
COMPLETED
Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
21-65 years
Phase:
PHASE3
Brief Summary
Black Americans with a family history of early heart disease tend to have a group of risk factors that can contribute to heart disease. These risk factors, which include excess body weight, high blood...
Detailed Description
Metabolic syndrome is a term that is used to describe a group of risk factors for coronary artery disease (CAD). The risk factors include abdominal obesity, insulin resistance, high cholesterol, and h...
Eligibility Criteria
Inclusion
- Participating in the Johns Hopkins Sibling and Family Heart Studies
- Has metabolic syndrome components
- Self-identifies as Black American
Exclusion
- Any clinical CAD
- Diabetes
- Major co-morbidity that precludes exercise (e.g., stroke, AIDS, cancer, neurological disorder, serious emphysema or exercise asthma, disabling arthritis)
- Resting systolic blood pressure greater than or equal to 160 mm Hg, resting diastolic blood pressure greater than or equal to 100 mm Hg, or exercise peak blood pressure greater than or equal to 250/115 mm Hg
- Known ejection fraction less than 40%
- Already participating in regular exercise, defined as 90 minutes per week of activities of greater than 5 metabolic equivalents (METS)
- Cardiac arrhythmias, including supraventricular tachycardia in the 5 years before study entry, any ventricular tachycardia, or greater than 4-beat runs of nonsustained premature ventricular contractions on baseline screening exercise testing
- Body mass index (BMI) greater than 45 kg/m2
- Alcohol or substance abuse in the 12 months before study entry
- A known abnormal exercise electrocardiogram and an abnormal thallium scan (double abnormal), a moderate to severe defect on thallium scan, or a coronary calcium score greater than 500 on a prior screening
- An abnormal exercise screening test supervised by a physician as part of this study
- Pregnant
- Current smokers if they have stated evidence of shortness of breath with normal exercises or a diagnosis of chronic obstructive pulmonary disease by their physician, as verified by medical records
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00783445
Start Date
December 1 2008
End Date
April 1 2013
Last Update
March 11 2014
Active Locations (1)
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1
Johns Hopkins Bayview Institute for Clinical Translational Research
Baltimore, Maryland, United States, 21287