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

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ClinicalTrials.gov Identifier: NCT02130336
Recruitment Status : Unknown
Verified December 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 5, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Exercise Physical Activity Behavioral: Aerobic interval training Behavioral: Continuous moderate-intensity exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome and Its Dose Response Study
Study Start Date : November 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : July 2015


Arm Intervention/treatment
Experimental: Aerobic interval training

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.

Behavioral: Aerobic interval training
Other Names:
  • AIT
  • High-intensity interval training

Experimental: Continuous moderate-intensity exercise

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.

Behavioral: Continuous moderate-intensity exercise
Other Names:
  • CME
  • Continuous moderate-intensity training

No Intervention: Control group
Subjects in control group will receive general exercise knowledge and counseling.



Primary Outcome Measures :
  1. Change from baseline in metabolic risk factors at 16-week [ Time Frame: baseline and 16-week ]
    Using blood test and anthropometric measurement to examine the differences between time points.

  2. Change from baseline in metabolic risk factors at 6-month follow-up [ Time Frame: baseline and 6-month after intervention completed ]
    Using blood test and anthropometric measurement to examine the differences between time points.

  3. Change from baseline in metabolic risk factors at 1-year follow-up [ Time Frame: baseline and 1-year after intervention completed ]
    Using blood test and anthropometric measurement to examine the differences between time points.


Secondary Outcome Measures :
  1. Change from baseline in exercise capacity at 16-week [ Time Frame: baseline and 16-week ]
    Using exercise testing to evaluate peak oxygen consumption at peak exercise to know the cardiopulmonary fitness in all subjects.

  2. Change from baseline in heart rate variability at 16-week [ Time Frame: 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.

  3. Change from baseline in pulse wave velocity at 16-week [ Time Frame: baseline and 16-week ]
    Assessing blood pressure in four limbs to analyze pulse wave velocity and evaluate the stiffness of peripheral arteries.

  4. Change from baseline in level of physical activity at 16-week [ Time Frame: baseline and 16-week ]
    Using 7-day recall physical activity questionnaire to examine the level of physical activity.

  5. Change from baseline in dietary status at 16-week [ Time Frame: baseline and 16-week ]
    Using dietary log to calculate caloric intake in recent one day.

  6. Change from baseline in metabonomics at 16-week [ Time Frame: baseline and 16-week ]
    Using blood test to analyze the differences in the activity of metabonomics.

  7. Change from baseline in exercise capacity at 6-month follow-up [ Time Frame: 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.

  8. Change from baseline in exercise capacity at 1-year follow-up [ Time Frame: 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.

  9. Change from baseline in heart rate variability at 6-month follow-up [ Time Frame: 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.

  10. Change from baseline in heart rate variability at 1-year follow-up [ Time Frame: 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.

  11. Change from baseline in pulse wave velocity at 6-month follow-up [ Time Frame: 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.

  12. Change from baseline in pulse wave velocity at 1-year follow-up [ Time Frame: 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.

  13. Change from baseline in level of physical activity at 6-month follow-up [ Time Frame: baseline and 6-month after intervention completed ]
    Using 7-day recall physical activity questionnaire to examine the level of physical activity.

  14. Change from baseline in level of physical activity at 1-year follow-up [ Time Frame: baseline and 1-year after intervention completed ]
    Using 7-day recall physical activity questionnaire to examine the level of physical activity.

  15. Change from baseline in dietary status at 6-month follow-up [ Time Frame: baseline and 6-month after intervention completed ]
    Using dietary log to calculate caloric intake in recent one day.

  16. Change from baseline in dietary status at 1-year follow-up [ Time Frame: baseline and 1-year after intervention completed ]
    Using dietary log to calculate caloric intake in recent one day.

  17. Change from baseline in metabonomics at 6-month follow-up [ Time Frame: baseline and 6-month after intervention completed ]
    Using blood test to analyze the differences in the activity of metabonomics.

  18. Change from baseline in metabonomics at 1-year follow-up [ Time Frame: baseline and 1-year after intervention completed ]
    Using blood test to analyze the differences in the activity of metabonomics.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130336


Contacts
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Contact: Meng-Yueh Chien, Ph.D 886-2-33668141 mychien@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Meng-Yueh Chien, Ph.D    886-2-33668141    mychien@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Meng-Yueh Chien, Ph.D National Taiwan University

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02130336     History of Changes
Other Study ID Numbers: 201112105RIC
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by National Taiwan University Hospital:
Metabolic syndrome
Metabolic risk factors
High-intensity interval training
Moderate-intensity exercise
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases