Exercise Program in Women With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929500
• Other study ID #: 2009P000121
• Status: Completed
• Phase: N/A
• First received: June 26, 2009
• Last updated: November 2, 2017
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: November 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2013
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• MAST program
MAST program: twice a week for 4 months

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center, Harvard University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Oxygen Uptake	To obtain peak oxygen uptake (VO2max; ml-1/min-1/kg), a symptom-limited exercise stress test was performed on a cycle ergometer. The test was preceded by a 2-minute warm-up at the intensity of 20 W. The first test load was 20 W, and was increased by 20 W at each 2-minute stage until the participants could no longer continue, i.e., they were unable to maintain pedaling frequency > 40 rpm, they achieved a respiratory exchange ratio of more than 1.0, or clinical criteria for test termination was observed. VO2max was measured and monitored with a breath-by-breath gas exchange system.	At baseline and after 4 months of intervention
Secondary	Cerebral Blood Flow Velocity (BFV)	Cerebral BFV was monitored using Transcranial Doppler Ultrasound.11 The middle cerebral artery was insonated from the temporal window by placing the 2-MegaHertZ (MHz) probe against the skin of the temporal region above the zygomatic arch. The probe was positioned to obtain maximal BFV and was fixed at the desired angle using a 3-dimensional positioning system. Once instrumented, BFV was continuously recorded throughout ten minutes of supine rest and 10-minutes on a table tilted to 80° from the horizontal position (head-up with foot plate support).	At baseline and after 4 months of intervention
Secondary	Trail Making Test	The Trail Making (TM) test is a measure of shifting attention. Participants are required to sequentially connect a series of numbered circles (Part A), and then to alternate between numbers and letters sequentially (Part B) (e.g., A-1-B-2-C-3..). Any participant who has not completed Part B within the standard 5 minutes (300 seconds) allotted for the task will be considered unable to complete the task. The scores in Part A (TM-A), Part B (TM-B) T scores ( age, education adjusted), and their difference (TM-B -TM-A) were calculated and used to measure executive function, i.e., lower scores indicates better performance.	At baseline and after 4 months of intervention
Secondary	Muscle Strength	MAST sessions were held twice a week for 16 weeks. Each exercise session consisted of 10 min of warm-up, 15-30 min of interval aerobic training by cycle ergometer according to the program, 20 min of strength training exercises, and 10 min of cool-down by stretching. The target heart rate (HR) increased progressively from 50% up to 80% of HR reserve by the end of the intervention period.The Karvonen formula ([(HRmax - HRrest)×(0.50 to 0.80)] + HRrest) was used to calculate the target HR. During every training session a new wireless computerized ECG monitoring system was used. After aerobic training, the strength training program was performed. Exercises used body mass as resistance and included squat, step-up-squat, step-up, heel rise, and sit-ups. Dumbbells were used as extra weight (5 or 10% of body weight) during other exercises except for sit-ups. The control group participated in an educational session once a month and kept physical activity diaries during the intervention period.	At baseline and after 4 months of intervention