Metabolic Syndrome XNCT02130336
The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome
A study testing Aerobic interval training and Continuous moderate-intensity exercise in people with Metabolic Syndrome X and Exercise, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Metabolic Syndrome X, Exercise, Physical Activity
- What is being tested?
- Aerobic interval training and Continuous moderate-intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-75 years old
- diagnosis of metabolic syndrome
- able to follow the instruction
Who cannot join
- unstable hypertension
- coronary artery disease or pulmonary diseases
- chronic kidney failure
- unable to perform exercise
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Meng-Yueh Chien, Ph.D, 886-2-33668141, mychien@ntu.edu.tw
About this study
Official title: The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome and Its Dose Response Study
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.
Read more
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.
Read the 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.
- Conditions
- Metabolic Syndrome X, Exercise, Physical Activity
- Being tested
- Aerobic interval training, Continuous moderate-intensity exercise
- Keywords
- Metabolic syndrome, Metabolic risk factors, High-intensity interval training, Moderate-intensity exercise
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval trainingBehavioural
Also called AIT, High-intensity interval training
Continuous moderate-intensity exerciseBehavioural
Also called CME, Continuous moderate-intensity training
| Study group | Role | What they receive |
|---|---|---|
| Aerobic interval training | Experimental | 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. Receives: Behavioral: Aerobic interval training |
| Continuous moderate-intensity exercise | Experimental | 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. Receives: Behavioral: Continuous moderate-intensity exercise |
| Control group | No intervention | Subjects in control group will receive general exercise knowledge and counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in metabolic risk factors at 16-week
Using blood test and anthropometric measurement to examine the differences between time points.
Measured: baseline and 16-week
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.
Measured: baseline and 6-month after intervention completed
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.
Measured: baseline and 1-year after intervention completed
Secondary outcomes (18)
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.
Measured: baseline and 16-week
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.
Measured: baseline and 16-week
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.
Measured: baseline and 16-week
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.
Measured: baseline and 16-week
Change from baseline in dietary status at 16-week
Using dietary log to calculate caloric intake in recent one day.
Measured: baseline and 16-week
Change from baseline in metabonomics at 16-week
Using blood test to analyze the differences in the activity of metabonomics.
Measured: baseline and 16-week
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.
Measured: baseline and 6-month after intervention completed
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.
Measured: baseline and 1-year after intervention completed
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.
Measured: baseline and 6-month after intervention completed
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.
Measured: baseline and 1-year after intervention completed
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.
Measured: baseline and 6-month after intervention completed
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.
Measured: baseline and 1-year after intervention completed
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.
Measured: baseline and 6-month after intervention completed
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.
Measured: baseline and 1-year after intervention completed
Change from baseline in dietary status at 6-month follow-up
Using dietary log to calculate caloric intake in recent one day.
Measured: baseline and 6-month after intervention completed
Change from baseline in dietary status at 1-year follow-up
Using dietary log to calculate caloric intake in recent one day.
Measured: baseline and 1-year after intervention completed
Change from baseline in metabonomics at 6-month follow-up
Using blood test to analyze the differences in the activity of metabonomics.
Measured: baseline and 6-month after intervention completed
Change from baseline in metabonomics at 1-year follow-up
Using blood test to analyze the differences in the activity of metabonomics.
Measured: baseline and 1-year after intervention completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startNov 2012
- Primary completionMay 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Yueh Chien, Ph.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130336
- Sponsor's protocol ID
- 201112105RIC
- Status last verified
- Dec 2014
- First submitted
- 28 Apr 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-intensity Aerobic Training in Patients With Metabolic Syndrome and Its Dose Response Study
- ClinicalTrials.gov ID
- NCT02130336
- Acronym / sponsor ID
- 201112105RIC
- Conditions
- Metabolic Syndrome X, Exercise, Physical Activity
- Keywords
- Metabolic syndrome, Metabolic risk factors, High-intensity interval training, Moderate-intensity exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 5 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic interval training | Experimental | Behavioral: Aerobic interval trainingFrequency: 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. |
| Continuous moderate-intensity exercise | Experimental | Behavioral: Continuous moderate-intensity exerciseFrequency: 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. |
| Control group | No intervention | –Subjects in control group will receive general exercise knowledge and counseling. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 45-75 years old
- diagnosis of metabolic syndrome
- able to follow the instruction
Key exclusion criteria (4 listed)
- unstable hypertension
- coronary artery disease or pulmonary diseases
- chronic kidney failure
- unable to perform exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic interval trainingAlso: AIT, High-intensity interval training | Behavioural | Aerobic interval training |
| Continuous moderate-intensity exerciseAlso: CME, Continuous moderate-intensity training | Behavioural | Continuous moderate-intensity exercise |
Primary outcome
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.
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.
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.
18 secondary outcomes
Change from baseline in exercise capacity at 16-week
Time frame: baseline and 16-week
Change from baseline in heart rate variability at 16-week
Time frame: baseline and 16-week
Change from baseline in pulse wave velocity at 16-week
Time frame: baseline and 16-week
Change from baseline in level of physical activity at 16-week
Time frame: baseline and 16-week
Change from baseline in dietary status at 16-week
Time frame: baseline and 16-week
Change from baseline in metabonomics at 16-week
Time frame: baseline and 16-week
Change from baseline in exercise capacity at 6-month follow-up
Time frame: baseline and 6-month after intervention completed
Change from baseline in exercise capacity at 1-year follow-up
Time frame: baseline and 1-year after intervention completed
Change from baseline in heart rate variability at 6-month follow-up
Time frame: baseline and 6-month after intervention completed
Change from baseline in heart rate variability at 1-year follow-up
Time frame: baseline and 1-year after intervention completed
Change from baseline in pulse wave velocity at 6-month follow-up
Time frame: baseline and 6-month after intervention completed
Change from baseline in pulse wave velocity at 1-year follow-up
Time frame: baseline and 1-year after intervention completed
Change from baseline in level of physical activity at 6-month follow-up
Time frame: baseline and 6-month after intervention completed
Change from baseline in level of physical activity at 1-year follow-up
Time frame: baseline and 1-year after intervention completed
Change from baseline in dietary status at 6-month follow-up
Time frame: baseline and 6-month after intervention completed
Change from baseline in dietary status at 1-year follow-up
Time frame: baseline and 1-year after intervention completed
Change from baseline in metabonomics at 6-month follow-up
Time frame: baseline and 6-month after intervention completed
Change from baseline in metabonomics at 1-year follow-up
Time frame: baseline and 1-year after intervention completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng-Yueh Chien, Ph.D principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic interval training and Continuous moderate-intensity exercise in people with Metabolic Syndrome X and Exercise, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng-Yueh Chien, Ph.D (886-2-33668141, mychien@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in metabolic risk factors at 16-week (time frame: baseline and 16-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.