Exercise Program in Women With Metabolic Syndrome

NCT00929500 | Completed Results

• 1 other identifier: 2009P000121
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cerebral Blood Flow Velocity (BFV)

  At baseline and after 4 months of intervention

• Trail Making Test

  At baseline and after 4 months of intervention

• Muscle Strength

  At baseline and after 4 months of intervention

Study Arms (2)

MAST program

EXPERIMENTAL

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.

Behavioral: MAST program

UC

NO INTERVENTION

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

Interventions

MAST program BEHAVIORAL

MAST program: twice a week for 4 months

MAST program

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center, Harvard University

Boston, Massachusetts, 02215, United States

Location

Related 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. doi: 10.1016/j.ijge.2013.05.002.

  PMID: 24634702 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Difficulty in recruiting older women with Metabolic syndrome, unwilling to participate due to time commitment and transportation difficulties, interrupt the recruitment process due to time constraints. Results should be interpreted with caution.

Results Point of Contact

• Title: Dr. Vera Novak
• Organization: Beth Israel Deaconess Medical Center

vnovak@bidmc.harvard.edu

617-632-8680

Study Officials

• Vera Novak, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, Director Safe Laboratory

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2013
• Last Updated: November 13, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)