Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00783445

Purpose

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 pressure, and high cholesterol, are known collectively as metabolic syndrome. This study will compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to determine which program is more effective at reducing the metabolic syndrome risk factors that can lead to heart disease.

Condition	Intervention	Phase
Metabolic Syndrome X	Behavioral: Community-Based Exercise Program (C-FIT) Behavioral: Self-Help Exercise Program (HOME)	Phase III

MedlinePlus related topics: Exercise and Physical Fitness Metabolic Syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Community Exercise and Metabolic Syndrome in Black Families

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Change in maximal oxygen consumption (VO2 max) [ Time Frame: Measured at baseline, Month 6, and Years 1 and 2 ] [ Designated as safety issue: No ]
Reduction in components of the metabolic syndrome [ Time Frame: Measured at baseline and Years 1 and 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

habitual physical activity score using a standardized questionnaire [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Exercise in a community setting while supervised by a coach	Behavioral: Community-Based Exercise Program (C-FIT) Participants will do 1 hour of exercise two to three times each week in a community setting for 1 year, while being supervised by a personal coach.
2: Active Comparator Self-exercise plan based on an individualized prescription after an initial fitness evaluation	Behavioral: Self-Help Exercise Program (HOME) After a fitness evaluation, participants will be given an exercise prescription and recommendations for home-based, self-mediated progressive exercise. Participants will be expected to do 1 hour of exercise two to three times each week for 1 year.

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 high blood pressure. People who live a sedentary lifestyle and do not get enough exercise are at risk of developing metabolic syndrome and CAD. Black Americans also have an increased risk of metabolic syndrome and CAD, particularly if they have a sibling younger than 60 years old who has premature CAD. Studies have shown that people who engage in regular, moderate intensity exercise can eliminate metabolic syndrome risk factors that can lead to CAD; however, many high-risk Black Americans do not take part in regular exercise. The purpose of this study is to compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to examine which program is more effective at reducing the metabolic syndrome risk factors that can lead to CAD in Black Americans.

This study will enroll Black Americans with metabolic syndrome who have a sibling with premature CAD. Participants will be randomly assigned (by individual) to either a community-based exercise program (C-FIT) or a self-help home-based exercise program (HOME). Participants in the C-FIT group will do 1 hour of exercise two to three times each week in a community setting and will be supervised by a personal coach or trainer for 1 year. Participants in the SELF group will undergo a fitness evaluation and will be instructed on how to exercise on their own. They also will be expected to do 1 hour of exercise two to three times each week for 1 year. Study visits will occur at baseline, Month 6, and Years 1 and 2. At all study visits, participants will undergo the following: a medical history review; physical examination; blood pressure measurements; blood collection; body measurements, including height, weight, and waist circumference; a treadmill stress test; a strength test; a dual-energy x-ray absorptiometry (DEXA) scan to measure body fat; an echocardiogram to examine the heart; a flow-mediated vasodilatation test for brachial reactivity to measure vascular function; and questionnaires on diet, exercise habits, and self-efficacy.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participating in the Johns Hopkins Sibling and Family Heart Studies
Has metabolic syndrome components
Self-identifies as Black American

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783445

Locations

United States, Maryland
Johns Hopkins Bayview Institute for Clinical Translational Research
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

More Information

No publications provided

Responsible Party:	Johns Hopkins University ( Diane M. Becker, MPH, ScD, Professor of Medicine )
Study ID Numbers:	610, R01 HL089474-01
Study First Received:	October 30, 2008
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00783445 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Metabolic Cardiovascular Syndrome
Metabolic Syndrome
Obesity
Hyperglycemia

Study placed in the following topic categories:

Hyperinsulinism
Obesity
Metabolic Diseases
Metabolic Syndrome X
Hyperglycemia

Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Abdominal Obesity Metabolic Syndrome

Additional relevant MeSH terms:

Hyperinsulinism
Metabolic Diseases
Pathologic Processes
Disease

Metabolic Syndrome X
Syndrome
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009