Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Community-Based Exercise Program (C-FIT)
Self-Help Exercise Program (HOME)
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Cardiovascular Syndrome, Metabolic Syndrome, Obesity, Hyperglycemia
Eligibility 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
Sites / Locations
- Johns Hopkins Bayview Institute for Clinical Translational Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Exercise in a community setting while supervised by a coach
Self-exercise plan based on an individualized prescription after an initial fitness evaluation
Outcomes
Primary Outcome Measures
Change in maximal oxygen consumption (VO2 max)
Reduction in components of the metabolic syndrome
Secondary Outcome Measures
habitual physical activity score using a standardized questionnaire
Full Information
NCT ID
NCT00783445
First Posted
October 30, 2008
Last Updated
March 10, 2014
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00783445
Brief Title
Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
Official Title
Community Exercise and Metabolic Syndrome in Black Families
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Cardiovascular Syndrome, Metabolic Syndrome, Obesity, Hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Exercise in a community setting while supervised by a coach
Arm Title
2
Arm Type
Active Comparator
Arm Description
Self-exercise plan based on an individualized prescription after an initial fitness evaluation
Intervention Type
Behavioral
Intervention Name(s)
Community-Based Exercise Program (C-FIT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Help Exercise Program (HOME)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in maximal oxygen consumption (VO2 max)
Time Frame
Measured at baseline, Month 6, and Years 1 and 2
Title
Reduction in components of the metabolic syndrome
Time Frame
Measured at baseline and Years 1 and 2
Secondary Outcome Measure Information:
Title
habitual physical activity score using a standardized questionnaire
Time Frame
6 months, 1 year, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Johns Hopkins Bayview Institute for Clinical Translational Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21785111
Citation
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.
Results Reference
background
PubMed Identifier
22215178
Citation
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.
Results Reference
result
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Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
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