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Exercise Program in Women With Metabolic Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00929500
Enrollment
28
Registered
2009-06-29
Start date
2009-07-31
Completion date
2013-12-31
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

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

BEHAVIORALMAST program

MAST program: twice a week for 4 months

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Maximal Oxygen UptakeAt baseline and after 4 months of interventionTo 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

MeasureTime frameDescription
Cerebral Blood Flow Velocity (BFV)At baseline and after 4 months of interventionCerebral 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 TestAt baseline and after 4 months of interventionThe 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 StrengthAt baseline and after 4 months of interventionMAST 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

ArmCount
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
Total8

Baseline characteristics

CharacteristicMAST ProgramUsual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants0 Participants1 Participants
Age, Categorical
Between 18 and 65 years
3 Participants4 Participants7 Participants
Age, Continuous60.25 years
STANDARD_DEVIATION 8.9
55.75 years
STANDARD_DEVIATION 6.07
58 years
STANDARD_DEVIATION 7.4
Sex: Female, Male
Female
4 Participants4 Participants8 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 4
other
Total, other adverse events
0 / 80 / 4
serious
Total, serious adverse events
1 / 80 / 4

Outcome results

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.

Time frame: At baseline and after 4 months of intervention

ArmMeasureGroupValue (MEAN)Dispersion
MAST ProgramMaximal Oxygen UptakeWeek 1618.6 ml/kg/minStandard Deviation 3.7
MAST ProgramMaximal Oxygen UptakeBaseline18.3 ml/kg/minStandard Deviation 3.8
Usual CareMaximal Oxygen UptakeBaseline15.8 ml/kg/minStandard Deviation 5
Usual CareMaximal Oxygen UptakeWeek 1614.4 ml/kg/minStandard Deviation 4.4
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).

Time frame: At baseline and after 4 months of intervention

ArmMeasureGroupValue (MEAN)Dispersion
MAST ProgramCerebral Blood Flow Velocity (BFV)Baseline (standing)33.3 cm/sStandard Deviation 7.4
MAST ProgramCerebral Blood Flow Velocity (BFV)Baseline (supine)37.4 cm/sStandard Deviation 11.7
MAST ProgramCerebral Blood Flow Velocity (BFV)Week 16 (supine)34.7 cm/sStandard Deviation 15.8
MAST ProgramCerebral Blood Flow Velocity (BFV)Week 16 (standing)33.2 cm/sStandard Deviation 16
Usual CareCerebral Blood Flow Velocity (BFV)Week 16 (standing)37.8 cm/sStandard Deviation 5.4
Usual CareCerebral Blood Flow Velocity (BFV)Baseline (standing)36.7 cm/sStandard Deviation 26.3
Usual CareCerebral Blood Flow Velocity (BFV)Week 16 (supine)33.9 cm/sStandard Deviation 15.7
Usual CareCerebral Blood Flow Velocity (BFV)Baseline (supine)41.7 cm/sStandard Deviation 31.9
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.

Time frame: At baseline and after 4 months of intervention

ArmMeasureGroupValue (MEAN)Dispersion
MAST ProgramMuscle StrengthBaseline96.7 WStandard Deviation 19.7
MAST ProgramMuscle StrengthWeek 16103.3 WStandard Deviation 23.4
Usual CareMuscle StrengthBaseline95 WStandard Deviation 19.1
Usual CareMuscle StrengthWeek 1690 WStandard Deviation 25.8
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.

Time frame: At baseline and after 4 months of intervention

ArmMeasureGroupValue (MEAN)Dispersion
MAST ProgramTrail Making TestTrail Making B (Baseline)78.4 T-scoreStandard Deviation 22.7
MAST ProgramTrail Making TestTrail Making A (Week 16)24.9 T-scoreStandard Deviation 7.7
MAST ProgramTrail Making TestTrail Making A (Baseline)29.1 T-scoreStandard Deviation 10.9
MAST ProgramTrail Making TestTrail Making B (Week 16)65.6 T-scoreStandard Deviation 23
MAST ProgramTrail Making TestTrail Making B-A (Baseline)49.3 T-scoreStandard Deviation 19.2
MAST ProgramTrail Making TestTrail Making B-A (Week 16)40.8 T-scoreStandard Deviation 21.2
Usual CareTrail Making TestTrail Making B-A (Baseline)33.7 T-scoreStandard Deviation 22.9
Usual CareTrail Making TestTrail Making A (Baseline)31.2 T-scoreStandard Deviation 9.3
Usual CareTrail Making TestTrail Making B (Baseline)64.9 T-scoreStandard Deviation 31.8
Usual CareTrail Making TestTrail Making B-A (Week 16)30.2 T-scoreStandard Deviation 2.6
Usual CareTrail Making TestTrail Making A (Week 16)29.7 T-scoreStandard Deviation 15.9
Usual CareTrail Making TestTrail Making B (Week 16)59.8 T-scoreStandard Deviation 14.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026