Trial Outcomes & Findings for Exercise Program in Women With Metabolic Syndrome (NCT NCT00929500)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

At baseline and after 4 months of intervention

Results posted on

2017-11-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	MAST Program Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months	Usual Care Usual Care (UC) with Educational Lectures
Overall Study STARTED	8	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise Program in Women With Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MAST Program n=4 Participants Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months	Usual Care n=4 Participants Usual Care (UC) with Educational Lectures	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	60.25 years STANDARD_DEVIATION 8.9 • n=5 Participants	55.75 years STANDARD_DEVIATION 6.07 • n=7 Participants	58 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MAST Program n=4 Participants Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months	Usual Care n=4 Participants Usual Care (UC) with Educational Lectures
Maximal Oxygen Uptake Baseline	18.3 ml/kg/min Standard Deviation 3.8	15.8 ml/kg/min Standard Deviation 5.0
Maximal Oxygen Uptake Week 16	18.6 ml/kg/min Standard Deviation 3.7	14.4 ml/kg/min Standard Deviation 4.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	MAST Program n=4 Participants Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months	Usual Care n=4 Participants Usual Care (UC) with Educational Lectures
Cerebral Blood Flow Velocity (BFV) Baseline (supine)	37.4 cm/s Standard Deviation 11.7	41.7 cm/s Standard Deviation 31.9
Cerebral Blood Flow Velocity (BFV) Week 16 (supine)	34.7 cm/s Standard Deviation 15.8	33.9 cm/s Standard Deviation 15.7
Cerebral Blood Flow Velocity (BFV) Baseline (standing)	33.3 cm/s Standard Deviation 7.4	36.7 cm/s Standard Deviation 26.3
Cerebral Blood Flow Velocity (BFV) Week 16 (standing)	33.2 cm/s Standard Deviation 16	37.8 cm/s Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MAST Program n=4 Participants Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months	Usual Care n=4 Participants Usual Care (UC) with Educational Lectures
Trail Making Test Trail Making A (Baseline)	29.1 T-score Standard Deviation 10.9	31.2 T-score Standard Deviation 9.3
Trail Making Test Trail Making B (Baseline)	78.4 T-score Standard Deviation 22.7	64.9 T-score Standard Deviation 31.8
Trail Making Test Trail Making B-A (Baseline)	49.3 T-score Standard Deviation 19.2	33.7 T-score Standard Deviation 22.9
Trail Making Test Trail Making A (Week 16)	24.9 T-score Standard Deviation 7.7	29.7 T-score Standard Deviation 15.9
Trail Making Test Trail Making B (Week 16)	65.6 T-score Standard Deviation 23	59.8 T-score Standard Deviation 14.8
Trail Making Test Trail Making B-A (Week 16)	40.8 T-score Standard Deviation 21.2	30.2 T-score Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MAST Program n=4 Participants Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months	Usual Care n=4 Participants Usual Care (UC) with Educational Lectures
Muscle Strength Baseline	96.7 W Standard Deviation 19.7	95 W Standard Deviation 19.1
Muscle Strength Week 16	103.3 W Standard Deviation 23.4	90 W Standard Deviation 25.8

Adverse Events

MAST Program

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MAST Program n=8 participants at risk Mixed Aerobic and Strength Training program (MAST) MAST program: MAST program: twice a week for 4 months	Usual Care n=4 participants at risk Usual Care (UC) with Educational Lectures
Cardiac disorders Myocardial infarction	12.5% 1/8 • 1 year	0.00% 0/4 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vera Novak

Beth Israel Deaconess Medical Center

Phone: 617-632-8680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place