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Exercise Program in Women With Metabolic Syndrome

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Behavioral: MAST program

Study type

Interventional

Funder types

Other

Identifiers

NCT00929500
2009P000121

Details and patient eligibility

About

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.

Full description

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.

Enrollment

28 patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

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
  • Transcranial Doppler (TCD) exclusion criteria - poor insonation window and TCD signal

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 2 patient groups

MAST program
Experimental group
Description:
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.
Treatment:
Behavioral: MAST program
UC
No Intervention group
Description:
Usual Care (UC) with Educational Lectures: No exercise sessions.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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