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Exercise Program in Women With Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929500
First Posted: June 29, 2009
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vera Novak, Beth Israel Deaconess Medical Center
  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 (Outcomes Assessor)
Primary Purpose: Other
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 Vera Novak, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Maximal Oxygen Uptake [ Time Frame: At baseline and after 4 months of intervention ]
    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.


Secondary Outcome Measures:
  • Cerebral Blood Flow Velocity (BFV) [ Time Frame: At baseline and after 4 months of intervention ]
    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).

  • Trail Making Test [ Time Frame: At baseline and after 4 months of intervention ]
    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), and their difference (TM-B -TM-A) were calculated and used to measure executive function, i.e., lower scores indicates better performance.

  • Muscle Strength [ Time Frame: At baseline and after 4 months of intervention ]
    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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
  • Transcranial Doppler (TCD) exclusion criteria - poor insonation window and TCD signal
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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: 2009P000121
First Submitted: June 26, 2009
First Posted: June 29, 2009
Results First Submitted: January 6, 2017
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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