Clinical trial NCT00929500: Exercise Program in Women With Metabolic Syndrome
Official title: The Effect of Mixed Aerobic and Strength Training Program on Physical Fitness and Cerebrovascular Function in Older Women With Metabolic Syndrome: A Pilot Study With Randomized Control Trial (RCT) Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2009-06-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal Oxygen Uptake
timeFrame: At baseline and after 4 months of intervention
Secondary outcomes:
measure: Cerebral Blood Flow Velocity (BFV)
timeFrame: At baseline and after 4 months of intervention
measure: Trail Making Test
timeFrame: At baseline and after 4 months of intervention
measure: Muscle Strength
timeFrame: At baseline and after 4 months of intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Harvard University
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Vera Novak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.