search
Back to results

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

Primary Purpose

Metabolic Syndrome X, Exercise, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aerobic interval training
Continuous moderate-intensity exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Metabolic syndrome, Metabolic risk factors, High-intensity interval training, Moderate-intensity exercise

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Aerobic interval training

Continuous moderate-intensity exercise

Control group

Arm Description

Frequency: Exercise 3 times a week. Twice under supervision and home exercise once a week. Duration: Totally 40 minutes in one session. Intensity: 10-minute warm-up and 5-minute cool-down at 40% maximal heart rate (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. Type: Using treadmill while under supervision.

Frequency: 5 times a week. Twice under supervision and home exercise 3 times a week. Duration: Totally 45 minutes per session. Intensity: 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 Type: Using treadmill under supervision.

Subjects in control group will receive general exercise knowledge and counseling.

Outcomes

Primary Outcome Measures

Change from baseline in metabolic risk factors at 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
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
Using blood test and anthropometric measurement to examine the differences between time points.

Secondary Outcome Measures

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.
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.
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.
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.
Change from baseline in dietary status at 16-week
Using dietary log to calculate caloric intake in recent one day.
Change from baseline in metabonomics at 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
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
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
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
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 6-month follow-up
Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.
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.
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.
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.
Change from baseline in dietary status at 6-month follow-up
Using dietary log to calculate caloric intake in recent one day.
Change from baseline in dietary status at 1-year follow-up
Using dietary log to calculate caloric intake in recent one day.
Change from baseline in metabonomics at 6-month follow-up
Using blood test to analyze the differences in the activity of metabonomics.
Change from baseline in metabonomics at 1-year follow-up
Using blood test to analyze the differences in the activity of metabonomics.

Full Information

First Posted
April 28, 2014
Last Updated
December 2, 2014
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02130336
Brief Title
The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome
Official Title
The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome and Its Dose Response Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Exercise, Physical Activity
Keywords
Metabolic syndrome, Metabolic risk factors, High-intensity interval training, Moderate-intensity exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic interval training
Arm Type
Experimental
Arm Description
Frequency: Exercise 3 times a week. Twice under supervision and home exercise once a week. Duration: Totally 40 minutes in one session. Intensity: 10-minute warm-up and 5-minute cool-down at 40% maximal heart rate (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. Type: Using treadmill while under supervision.
Arm Title
Continuous moderate-intensity exercise
Arm Type
Experimental
Arm Description
Frequency: 5 times a week. Twice under supervision and home exercise 3 times a week. Duration: Totally 45 minutes per session. Intensity: 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 Type: Using treadmill under supervision.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects in control group will receive general exercise knowledge and counseling.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic interval training
Other Intervention Name(s)
AIT, High-intensity interval training
Intervention Type
Behavioral
Intervention Name(s)
Continuous moderate-intensity exercise
Other Intervention Name(s)
CME, Continuous moderate-intensity training
Primary Outcome Measure Information:
Title
Change from baseline in metabolic risk factors at 16-week
Description
Using blood test and anthropometric measurement to examine the differences between time points.
Time Frame
baseline and 16-week
Title
Change from baseline in metabolic risk factors at 6-month follow-up
Description
Using blood test and anthropometric measurement to examine the differences between time points.
Time Frame
baseline and 6-month after intervention completed
Title
Change from baseline in metabolic risk factors at 1-year follow-up
Description
Using blood test and anthropometric measurement to examine the differences between time points.
Time Frame
baseline and 1-year after intervention completed
Secondary Outcome Measure Information:
Title
Change from baseline in exercise capacity at 16-week
Description
Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects.
Time Frame
baseline and 16-week
Title
Change from baseline in heart rate variability at 16-week
Description
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.
Time Frame
baseline and 16-week
Title
Change from baseline in pulse wave velocity at 16-week
Description
Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.
Time Frame
baseline and 16-week
Title
Change from baseline in level of physical activity at 16-week
Description
Using 7-day recall physical activity questionnaire to examine the level of physical activity.
Time Frame
baseline and 16-week
Title
Change from baseline in dietary status at 16-week
Description
Using dietary log to calculate caloric intake in recent one day.
Time Frame
baseline and 16-week
Title
Change from baseline in metabonomics at 16-week
Description
Using blood test to analyze the differences in the activity of metabonomics.
Time Frame
baseline and 16-week
Title
Change from baseline in exercise capacity at 6-month follow-up
Description
Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects.
Time Frame
baseline and 6-month after intervention completed
Title
Change from baseline in exercise capacity at 1-year follow-up
Description
Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects.
Time Frame
baseline and 1-year after intervention completed
Title
Change from baseline in heart rate variability at 6-month follow-up
Description
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.
Time Frame
baseline and 6-month after intervention completed
Title
Change from baseline in heart rate variability at 1-year follow-up
Description
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.
Time Frame
baseline and 1-year after intervention completed
Title
Change from baseline in pulse wave velocity at 6-month follow-up
Description
Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.
Time Frame
baseline and 6-month after intervention completed
Title
Change from baseline in pulse wave velocity at 1-year follow-up
Description
Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.
Time Frame
baseline and 1-year after intervention completed
Title
Change from baseline in level of physical activity at 6-month follow-up
Description
Using 7-day recall physical activity questionnaire to examine the level of physical activity.
Time Frame
baseline and 6-month after intervention completed
Title
Change from baseline in level of physical activity at 1-year follow-up
Description
Using 7-day recall physical activity questionnaire to examine the level of physical activity.
Time Frame
baseline and 1-year after intervention completed
Title
Change from baseline in dietary status at 6-month follow-up
Description
Using dietary log to calculate caloric intake in recent one day.
Time Frame
baseline and 6-month after intervention completed
Title
Change from baseline in dietary status at 1-year follow-up
Description
Using dietary log to calculate caloric intake in recent one day.
Time Frame
baseline and 1-year after intervention completed
Title
Change from baseline in metabonomics at 6-month follow-up
Description
Using blood test to analyze the differences in the activity of metabonomics.
Time Frame
baseline and 6-month after intervention completed
Title
Change from baseline in metabonomics at 1-year follow-up
Description
Using blood test to analyze the differences in the activity of metabonomics.
Time Frame
baseline and 1-year after intervention completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meng-Yueh Chien, Ph.D
Phone
886-2-33668141
Email
mychien@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng-Yueh Chien, Ph.D
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng-Yueh Chien, Ph.D
Phone
886-2-33668141
Email
mychien@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs