Metabolic Syndrome
Conditions
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.
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.
Interventions
MAST program: twice a week for 4 months
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Oxygen Uptake | 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
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Blood Flow Velocity (BFV) | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| MAST Program Mixed Aerobic and Strength Training program (MAST)
MAST program: MAST program: twice a week for 4 months | 4 |
| Usual Care Usual Care (UC) with Educational Lectures | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | MAST Program | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 60.25 years STANDARD_DEVIATION 8.9 | 55.75 years STANDARD_DEVIATION 6.07 | 58 years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 0 / 8 | 0 / 4 |
| serious Total, serious adverse events | 1 / 8 | 0 / 4 |
Outcome results
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.
Time frame: At baseline and after 4 months of intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST Program | Maximal Oxygen Uptake | Week 16 | 18.6 ml/kg/min | Standard Deviation 3.7 |
| MAST Program | Maximal Oxygen Uptake | Baseline | 18.3 ml/kg/min | Standard Deviation 3.8 |
| Usual Care | Maximal Oxygen Uptake | Baseline | 15.8 ml/kg/min | Standard Deviation 5 |
| Usual Care | Maximal Oxygen Uptake | Week 16 | 14.4 ml/kg/min | Standard Deviation 4.4 |
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).
Time frame: At baseline and after 4 months of intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST Program | Cerebral Blood Flow Velocity (BFV) | Baseline (standing) | 33.3 cm/s | Standard Deviation 7.4 |
| MAST Program | Cerebral Blood Flow Velocity (BFV) | Baseline (supine) | 37.4 cm/s | Standard Deviation 11.7 |
| MAST Program | Cerebral Blood Flow Velocity (BFV) | Week 16 (supine) | 34.7 cm/s | Standard Deviation 15.8 |
| MAST Program | Cerebral Blood Flow Velocity (BFV) | Week 16 (standing) | 33.2 cm/s | Standard Deviation 16 |
| Usual Care | Cerebral Blood Flow Velocity (BFV) | Week 16 (standing) | 37.8 cm/s | Standard Deviation 5.4 |
| Usual Care | Cerebral Blood Flow Velocity (BFV) | Baseline (standing) | 36.7 cm/s | Standard Deviation 26.3 |
| Usual Care | Cerebral Blood Flow Velocity (BFV) | Week 16 (supine) | 33.9 cm/s | Standard Deviation 15.7 |
| Usual Care | Cerebral Blood Flow Velocity (BFV) | Baseline (supine) | 41.7 cm/s | Standard Deviation 31.9 |
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.
Time frame: At baseline and after 4 months of intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST Program | Muscle Strength | Baseline | 96.7 W | Standard Deviation 19.7 |
| MAST Program | Muscle Strength | Week 16 | 103.3 W | Standard Deviation 23.4 |
| Usual Care | Muscle Strength | Baseline | 95 W | Standard Deviation 19.1 |
| Usual Care | Muscle Strength | Week 16 | 90 W | Standard Deviation 25.8 |
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.
Time frame: At baseline and after 4 months of intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAST Program | Trail Making Test | Trail Making B (Baseline) | 78.4 T-score | Standard Deviation 22.7 |
| MAST Program | Trail Making Test | Trail Making A (Week 16) | 24.9 T-score | Standard Deviation 7.7 |
| MAST Program | Trail Making Test | Trail Making A (Baseline) | 29.1 T-score | Standard Deviation 10.9 |
| MAST Program | Trail Making Test | Trail Making B (Week 16) | 65.6 T-score | Standard Deviation 23 |
| MAST Program | Trail Making Test | Trail Making B-A (Baseline) | 49.3 T-score | Standard Deviation 19.2 |
| MAST Program | Trail Making Test | Trail Making B-A (Week 16) | 40.8 T-score | Standard Deviation 21.2 |
| Usual Care | Trail Making Test | Trail Making B-A (Baseline) | 33.7 T-score | Standard Deviation 22.9 |
| Usual Care | Trail Making Test | Trail Making A (Baseline) | 31.2 T-score | Standard Deviation 9.3 |
| Usual Care | Trail Making Test | Trail Making B (Baseline) | 64.9 T-score | Standard Deviation 31.8 |
| Usual Care | Trail Making Test | Trail Making B-A (Week 16) | 30.2 T-score | Standard Deviation 2.6 |
| Usual Care | Trail Making Test | Trail Making A (Week 16) | 29.7 T-score | Standard Deviation 15.9 |
| Usual Care | Trail Making Test | Trail Making B (Week 16) | 59.8 T-score | Standard Deviation 14.8 |