Exercise Program in Women With Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT00929500|
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : September 18, 2017
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: MAST program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||December 2013|
Experimental: MAST program
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
MAST program: twice a week for 4 months
No Intervention: UC
Usual Care (UC) with Educational Lectures: No exercise sessions.
- 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.
- 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) 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929500
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center, Harvard University|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Vera Novak, MD, PhD||Beth Israel Deaconess Medical Center|