The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome and Its Dose Response Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline in metabolic risk factors at 16-week
研究概览
简要总结
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.
详细描述
Intervention (exercise) protocol:
- 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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45-75 years old
- •diagnosis of metabolic syndrome
- •able to follow the instruction
排除标准
- •unstable hypertension
- •coronary artery disease or pulmonary diseases
- •chronic kidney failure
- •unable to perform exercise
结局指标
主要结局
Change from baseline in metabolic risk factors at 16-week
时间窗: 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
时间窗: 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
时间窗: baseline and 1-year after intervention completed
Using blood test and anthropometric measurement to examine the differences between time points.
次要结局
- Change from baseline in heart rate variability at 16-week(baseline and 16-week)
- Change from baseline in exercise capacity at 6-month follow-up(baseline and 6-month after intervention completed)
- Change from baseline in exercise capacity at 1-year follow-up(baseline and 1-year after intervention completed)
- Change from baseline in heart rate variability at 6-month follow-up(baseline and 6-month after intervention completed)
- Change from baseline in metabonomics at 16-week(baseline and 16-week)
- Change from baseline in pulse wave velocity at 6-month follow-up(baseline and 6-month after intervention completed)
- Change from baseline in dietary status at 1-year follow-up(baseline and 1-year after intervention completed)
- Change from baseline in exercise capacity at 16-week(baseline and 16-week)
- Change from baseline in pulse wave velocity at 16-week(baseline and 16-week)
- Change from baseline in level of physical activity at 16-week(baseline and 16-week)
- Change from baseline in heart rate variability at 1-year follow-up(baseline and 1-year after intervention completed)
- Change from baseline in level of physical activity at 6-month follow-up(baseline and 6-month after intervention completed)
- Change from baseline in metabonomics at 6-month follow-up(baseline and 6-month after intervention completed)
- Change from baseline in metabonomics at 1-year follow-up(baseline and 1-year after intervention completed)
- Change from baseline in dietary status at 16-week(baseline and 16-week)
- Change from baseline in pulse wave velocity at 1-year follow-up(baseline and 1-year after intervention completed)
- Change from baseline in level of physical activity at 1-year follow-up(baseline and 1-year after intervention completed)
- Change from baseline in dietary status at 6-month follow-up(baseline and 6-month after intervention completed)