Exercise Program in Women With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vera Novak, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00929500
First received: June 26, 2009
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Behavioral: MAST program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Maximal oxygen uptake [ Time Frame: At baseline and after 4 months of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebral blood flow velocity [ Time Frame: At baseline and after 4 months of intervention ] [ Designated as safety issue: No ]
  • Cognitive functions [ Time Frame: At baseline and after 4 months of intervention ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: At baseline and after 4 months of intervention ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: July 2009
Study Completion Date: December 2013
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MAST program
Mixed Aerobic and Strength Training program (MAST)
Behavioral: MAST program
MAST program: twice a week for 4 months
No Intervention: UC
Usual Care (UC) with Educational Lectures

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • TCD exclusion criteria - poor insonation window and TCD signal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929500

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center, Harvard University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Vera Novak, Associate Professor of Neurology, Director Safe Laboratory, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00929500     History of Changes
Other Study ID Numbers: 2009p-000121
Study First Received: June 26, 2009
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014