Metabolic Syndrome X, Exercise, Physical Activity
Conditions
Keywords
Metabolic syndrome, Metabolic risk factors, High-intensity interval training, Moderate-intensity exercise
Brief summary
Background. The prevalence of metabolic syndrome (MetS) has been increasing, and its risk is positively correlated with age. Due to ageing society in Taiwan, how to treat metabolic syndrome and decrease the complications is an important health issue. Relatively few studies have been focusing on the effects of exercise training in patients with MetS with long-term follow-up. Recently, high-intensity interval training or aerobic interval training (AIT) consisting of high intensity separated by active recovery has been proposed to be more effective than isocaloric continuous moderate-intensity exercise (CME) in raising exercise capacity (VO2max) in some specific patient population. Purpose. The purposes are to (1) compare the effects of 16-week CME and AIT on reducing the numbers of metabolic risk factors in patients with MetS and the prevalence. Hypothesis: 16-week AIT reduces more metabolic risk factors than CME in patients with MetS. Methods. This study will be a multiple-center trial. One hundred and twenty patients, aged ≥45 years, with a diagnosis of MetS for each center will be recruited. Subjects will be randomly assigned to either control, CME, or AIT group after baseline assessments. Participants in control group will receive usual care and the others in two exercise groups will undergo 16-week exercise training. All subjects will receive 16-week, 6-month and 1-year follow-ups including blood test, body composition (body mass index, waist circumference), pulse wave velocity, and maximal exercise testing. Statistical analysis will be conducted using SPSS 11.5, p \< 0.05 indicating statistical significance. Data will be presented in mean±standard deviation or number (percentile) with intention-to-treat analysis. Chi-square test or one-way Analysis of Variance (ANOVA) will be used to compare whether there are between-group differences at baseline. Two-way repeated measures ANOVA and post-hoc test will be performed to examine time and group effect if there is interaction effect, otherwise Bonferroni will be used. The subgroup analysis between MetS and n-MetS after training will be performed using the same statistical methods.
Detailed description
Intervention (exercise) protocol: 1. CME group: exercise at least 30-minute moderate intensity 5 times a week, twice on treadmill under supervision and home exercise 3 times a week. CME protocol including 10-minute warm-up at 40% maximal heart rate (HRmax), 30-minute moderate intensity exercise at 50-70% HRmax and 5-minute cool-down at 40% HRmax 2. AIT group: exercise 3 times a week including twice on treadmill under supervision and home exercise once a week. AIT protocol including 10-minute warm-up and 5-minute cool-down at 40% HRmax, participants and exercise 4-minute high-intensity training at 85-90% HRmax and 4 times separated by 3-minute active recovery at 70% HRmax.
Interventions
BEHAVIORALContinuous moderate-intensity exercise
BEHAVIORALAerobic interval training
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 45-75 years old * diagnosis of metabolic syndrome * able to follow the instruction
Exclusion criteria
* unstable hypertension * coronary artery disease or pulmonary diseases * chronic kidney failure * unable to perform exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in metabolic risk factors at 16-week | baseline and 16-week | Using blood test and anthropometric measurement to examine the differences between time points. |
| Change from baseline in metabolic risk factors at 6-month follow-up | baseline and 6-month after intervention completed | Using blood test and anthropometric measurement to examine the differences between time points. |
| Change from baseline in metabolic risk factors at 1-year follow-up | baseline and 1-year after intervention completed | Using blood test and anthropometric measurement to examine the differences between time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in level of physical activity at 16-week | baseline and 16-week | Using 7-day recall physical activity questionnaire to examine the level of physical activity. |
| Change from baseline in dietary status at 16-week | baseline and 16-week | Using dietary log to calculate caloric intake in recent one day. |
| Change from baseline in metabonomics at 16-week | baseline and 16-week | Using blood test to analyze the differences in the activity of metabonomics. |
| Change from baseline in exercise capacity at 6-month follow-up | baseline and 6-month after intervention completed | Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects. |
| Change from baseline in exercise capacity at 1-year follow-up | baseline and 1-year after intervention completed | Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects. |
| Change from baseline in heart rate variability at 6-month follow-up | baseline and 6-month after intervention completed | Assessing continuous heart rate at resting (10-min), during exercise testing, and after exercise testing (10-min) and further analyzing heart rate variability in time and frequency domain. |
| Change from baseline in heart rate variability at 1-year follow-up | baseline and 1-year after intervention completed | Assessing continuous heart rate at resting (10-min), during exercise testing, and after exercise testing (10-min) and further analyzing heart rate variability in time and frequency domain. |
| Change from baseline in exercise capacity at 16-week | baseline and 16-week | Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects. |
| Change from baseline in pulse wave velocity at 1-year follow-up | baseline and 1-year after intervention completed | Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries. |
| Change from baseline in level of physical activity at 6-month follow-up | baseline and 6-month after intervention completed | Using 7-day recall physical activity questionnaire to examine the level of physical activity. |
| Change from baseline in level of physical activity at 1-year follow-up | baseline and 1-year after intervention completed | Using 7-day recall physical activity questionnaire to examine the level of physical activity. |
| Change from baseline in dietary status at 6-month follow-up | baseline and 6-month after intervention completed | Using dietary log to calculate caloric intake in recent one day. |
| Change from baseline in dietary status at 1-year follow-up | baseline and 1-year after intervention completed | Using dietary log to calculate caloric intake in recent one day. |
| Change from baseline in metabonomics at 6-month follow-up | baseline and 6-month after intervention completed | Using blood test to analyze the differences in the activity of metabonomics. |
| Change from baseline in metabonomics at 1-year follow-up | baseline and 1-year after intervention completed | Using blood test to analyze the differences in the activity of metabonomics. |
| Change from baseline in pulse wave velocity at 6-month follow-up | baseline and 6-month after intervention completed | Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries. |
| Change from baseline in heart rate variability at 16-week | baseline and 16-week | Assessing continuous heart rate at resting (10-min), during exercise testing, and after exercise testing (10-min) and further analyzing heart rate variability in time and frequency domain. |
| Change from baseline in pulse wave velocity at 16-week | baseline and 16-week | Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries. |
Countries
Taiwan
Contacts
Primary ContactMeng-Yueh Chien, Ph.D
Outcome results
None listed