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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| UC | No Intervention | Usual Care (UC) with Educational Lectures: No exercise sessions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAST program | Behavioral | MAST program: twice a week for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vera Novak, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center, Harvard University | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24634702 | Result | 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. |
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A total of 28 subjects were consented. Of those, 16 were determined ineligible to participate. 12 subjects were randomized (8 to intervention group and 4 to control group). At the end of the trial, only 4 intervention and 4 sontrol subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MAST Program | Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months |
| FG001 | Usual Care | Usual Care (UC) with Educational Lectures |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MAST Program | Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months |
| BG001 | Usual Care | Usual Care (UC) with Educational Lectures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ml/kg/min | At baseline and after 4 months of intervention |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MAST Program | Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | Subject suffered a myocardial infarction during a gastric bypass surgery after enrollment in study and randomized, but prior to starting the exercise training program. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vera Novak | Beth Israel Deaconess Medical Center | 617-632-8680 | vnovak@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| At baseline and after 4 months of intervention |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Usual Care |
Usual Care (UC) with Educational Lectures |
|
|
| 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). | Posted | Mean | Standard Deviation | cm/s | 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. | Posted | Mean | Standard Deviation | T-score | 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. | Posted | Mean | Standard Deviation | W | At baseline and after 4 months of intervention |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 0 |
| 8 |
| EG001 | Usual Care | Usual Care (UC) with Educational Lectures | 0 | 4 | 0 | 4 | 0 | 4 |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| Baseline (standing) |
|
| Week 16 (standing) |
|
| Trail Making B-A (Baseline) |
|
| Trail Making A (Week 16) |
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| Trail Making B (Week 16) |
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| Trail Making B-A (Week 16) |
|