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

NCT00783445 | Completed Phase 3 DMC

• 2 other identifiers: 610R01HL089474-01
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Cardiovascular Syndrome; Metabolic Syndrome; Obesity; Hyperglycemia

Outcome Measures

Primary Outcomes (2)

• Change in maximal oxygen consumption (VO2 max)

  Measured at baseline, Month 6, and Years 1 and 2

• Reduction in components of the metabolic syndrome

  Measured at baseline and Years 1 and 2

Secondary Outcomes (1)

• habitual physical activity score using a standardized questionnaire

  6 months, 1 year, 2 years

Study Arms (2)

1

EXPERIMENTAL

Exercise in a community setting while supervised by a coach

Behavioral: Community-Based Exercise Program (C-FIT)

2

ACTIVE COMPARATOR

Self-exercise plan based on an individualized prescription after an initial fitness evaluation

Behavioral: Self-Help Exercise Program (HOME)

Interventions

Community-Based Exercise Program (C-FIT) BEHAVIORAL

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.

1

Self-Help Exercise Program (HOME) BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Bayview Institute for Clinical Translational Research

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Kral BG, Becker LC, Vaidya D, Yanek LR, Becker DM. Silent myocardial ischaemia and long-term coronary artery disease outcomes in apparently healthy people from families with early-onset ischaemic heart disease. Eur Heart J. 2011 Nov;32(22):2766-72. doi: 10.1093/eurheartj/ehr261. Epub 2011 Jul 23.

  PMID: 21785111 BACKGROUND

• Brown RV, Kral BG, Yanek LR, Vaidya D, Nyquist PA, Levine DM, Moy TF, Becker LC, Becker DM. Ethnic-specific determinants of exercise capacity in a healthy high-risk population. Med Sci Sports Exerc. 2012 Jun;44(6):1150-6. doi: 10.1249/MSS.0b013e3182456990.

  PMID: 22215178 RESULT

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Hyperglycemia

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

US (1)