The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome

Physical Activity Clinical Trial

Official title:

The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome and Its Dose Response Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02130336
• Other study ID #: 201112105RIC
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: December 2, 2014
• Start date: November 2012
• Est. completion date: July 2015

Study information

• Verified date: December 2014
• Source: National Taiwan University Hospital
• Contact: Meng-Yueh Chien, Ph.D
• Phone: 886-2-33668141
• Email: mychien[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise
• Metabolic Syndrome X
• Physical Activity
• Syndrome

Intervention

Behavioral:
• Aerobic interval training

• Continuous moderate-intensity exercise

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in metabolic risk factors at 16-week	Using blood test and anthropometric measurement to examine the differences between time points.	baseline and 16-week	No
Primary	Change from baseline in metabolic risk factors at 6-month follow-up	Using blood test and anthropometric measurement to examine the differences between time points.	baseline and 6-month after intervention completed	No
Primary	Change from baseline in metabolic risk factors at 1-year follow-up	Using blood test and anthropometric measurement to examine the differences between time points.	baseline and 1-year after intervention completed	No
Secondary	Change from baseline in exercise capacity at 16-week	Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects.	baseline and 16-week	No
Secondary	Change from baseline in heart rate variability at 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.	baseline and 16-week	No
Secondary	Change from baseline in pulse wave velocity at 16-week	Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.	baseline and 16-week	No
Secondary	Change from baseline in level of physical activity at 16-week	Using 7-day recall physical activity questionnaire to examine the level of physical activity.	baseline and 16-week	No
Secondary	Change from baseline in dietary status at 16-week	Using dietary log to calculate caloric intake in recent one day.	baseline and 16-week	No
Secondary	Change from baseline in metabonomics at 16-week	Using blood test to analyze the differences in the activity of metabonomics.	baseline and 16-week	No
Secondary	Change from baseline in exercise capacity at 6-month follow-up	Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects.	baseline and 6-month after intervention completed	No
Secondary	Change from baseline in exercise capacity at 1-year follow-up	Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects.	baseline and 1-year after intervention completed	No
Secondary	Change from baseline in heart rate variability at 6-month follow-up	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.	baseline and 6-month after intervention completed	No
Secondary	Change from baseline in heart rate variability at 1-year follow-up	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.	baseline and 1-year after intervention completed	No
Secondary	Change from baseline in pulse wave velocity at 6-month follow-up	Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.	baseline and 6-month after intervention completed	No
Secondary	Change from baseline in pulse wave velocity at 1-year follow-up	Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.	baseline and 1-year after intervention completed	No
Secondary	Change from baseline in level of physical activity at 6-month follow-up	Using 7-day recall physical activity questionnaire to examine the level of physical activity.	baseline and 6-month after intervention completed	No
Secondary	Change from baseline in level of physical activity at 1-year follow-up	Using 7-day recall physical activity questionnaire to examine the level of physical activity.	baseline and 1-year after intervention completed	No
Secondary	Change from baseline in dietary status at 6-month follow-up	Using dietary log to calculate caloric intake in recent one day.	baseline and 6-month after intervention completed	No
Secondary	Change from baseline in dietary status at 1-year follow-up	Using dietary log to calculate caloric intake in recent one day.	baseline and 1-year after intervention completed	No
Secondary	Change from baseline in metabonomics at 6-month follow-up	Using blood test to analyze the differences in the activity of metabonomics.	baseline and 6-month after intervention completed	No
Secondary	Change from baseline in metabonomics at 1-year follow-up	Using blood test to analyze the differences in the activity of metabonomics.	baseline and 1-year after intervention completed	No