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

NCT02130336 | Unknown

• 1 other identifier: 201112105RIC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X; Exercise; Physical Activity

Keywords

Metabolic syndrome; Metabolic risk factors; High-intensity interval training; Moderate-intensity exercise

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (18)

• Change from baseline in exercise capacity at 16-week

  baseline and 16-week

• Change from baseline in heart rate variability 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 dietary status at 16-week

  baseline and 16-week

Study Arms (3)

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.

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.

Behavioral: Continuous moderate-intensity exercise

Control group

NO INTERVENTION

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

Interventions

Aerobic interval training BEHAVIORAL

Also known as: AIT, High-intensity interval training

Aerobic interval training

Continuous moderate-intensity exercise BEHAVIORAL

Also known as: CME, Continuous moderate-intensity training

Continuous moderate-intensity exercise

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• diagnosis of metabolic syndrome
• able to follow the instruction

You may not qualify if:

• unstable hypertension
• coronary artery disease or pulmonary diseases
• chronic kidney failure
• unable to perform exercise

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Meng-Yueh Chien, Ph.D

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng-Yueh Chien, Ph.D

CONTACT

886-2-33668141; mychien@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 5, 2014
• Study Start: November 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

TW (1)