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Exercise Program in Women With Metabolic Syndrome

NCT ID: NCT00929500

Last Updated: 2017-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to test whether a supervised mixed aerobic and strength training (MAST) program is effective in improving overall physical fitness and blood flow in the brain and lowering risk factors of coronary artery disease (CAD) in women with metabolic syndrome.

Detailed Description

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Metabolic syndrome is a cluster of conditions and disorders that increase the risk for coronary artery disease (CAD) and strokes. Sedentary lifestyle is one of the risk factors, which decrease overall physical fitness and together with aging may lead to decrease in physical functioning in everyday life as well as changes in blood flow in the brain and cognitive functions. Regular physical activity is associated with a reduced risk of cardiovascular disease. It may also improve blood flow velocity and cognitive functions. Physical activity should be as effective as possible, but also as safe as possible. Supervised mixed aerobic and strength training (MAST) program for 4 months enables to individualize the intensity of aerobic exercise based on measured maximal exercise capacity. Throughout each training session heart rate will be monitored with a new real time wireless ECG system.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MAST program

Mixed Aerobic and Strength Training program (MAST): Each exercise session consisted of 10 minutes of warm-up, 15-30 minutes of interval aerobic training by cycle ergometer according to the program, 20 minutes of strength training exercises, and 10 minutes of cool-down by stretching.

Group Type EXPERIMENTAL

MAST program

Intervention Type BEHAVIORAL

MAST program: twice a week for 4 months

UC

Usual Care (UC) with Educational Lectures: No exercise sessions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MAST program

MAST program: twice a week for 4 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal women
* Age 50 or over
* Diagnosed metabolic syndrome

Exclusion Criteria

* Any unstable or acute medical condition that the study physician deem unsafe for participation
* Positive stress test for CAD or other ischemic conditions
* Myocardial infarction or major surgery within 6 months
* History of a clinically documented stroke
* Clinical dementia (by history) or inability to follow details of the protocol
* Carotid stenosis \> 50% by medical history
* Insulin dependent diabetes mellitus (also type II, if using insulin) or history of severe hypoglycemic episodes within 6 months requiring hospitalization
* Liver or renal failure or transplant
* Severe blood pressure elevation (systolic BP \> 180 and/or diastolic BP \> 110 mm Hg)
* Anemia (Hb \< 10)
* Seizure disorders
* Current recreational drug or alcohol abuse
* BMI \> 45, but body weight under 280 lbs
* Inability to obtain permission for participation from the primary care physician
* Clinically significant and movement limiting hip, knee and/or back disorders or injury, and rheumatoid arthritis
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Vera Novak

Associate Professor of Neurology, Director Safe Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vera Novak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center, Harvard University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Heli V, Ihab H, Kun H, Brad M, Jessica W, Vera N. Effects of exercise program on physiological functions in postmenopausal women with metabolic syndrome. Int J Gerontol. 2013 Dec;7(4):231-235. doi: 10.1016/j.ijge.2013.05.002.

Reference Type RESULT
PMID: 24634702 (View on PubMed)

Other Identifiers

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2009P000121

Identifier Type: -

Identifier Source: org_study_id