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Clinical Trials/NCT04496388
NCT04496388CompletedNot Applicable

The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.

National Taiwan University1 site in 1 country72 target enrollmentStarted: April 7, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
72
Locations
1
Primary Endpoint
visceral adipose tissue

Study Overview

Brief Summary

Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and metabolic syndrome. However, there is controversial data from prior studies to inform the type of exercise training recommendations.

Aim: The aim of this study will determine the differences of different type of exercise in the effects of reducing insulin resistance and visceral adipose tissue for community residents.

Methods: The four-arm randomized controlled trial will conducted in adults aged 40 to 70 years old in Tainan. A total of at least 177 patients will randomly assign to the group of aerobic exercise (AE), aerobic exercise combined with resistance exercise (RE), AE combined with medium intensity interval training, and placebo. The participants in exercise group will received 12 weeks, 3 times per week program, including twice a week intervention guided by the intervenors, and once a week exercise guided by the video at home. All the exercise keeps moderate-intensity by monitoring with 64%-75% of the maximum heart rate. Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin μU/mL)× glucose(mmol/L)/22.5).

Relevance to clinical practice: The research findings will help the clinical health works to know which type of exercise is the best choice in reducing insulin resistance and visceral adipose tissue in community residents, and can be promoted to the general public to reduce the prevalence of metabolic syndrome as well as prevent the root causes of ill health.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •adults aged 40 to 70 years old.
  • •without regular exercise in the past six years.

Exclusion Criteria

  • •recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg.
  • •those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.

Arms & Interventions

Aerobic exercise

Experimental

Aerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after exercise.

Intervention: exercise (Behavioral)

Aerobic exercise combined with resistance exercise

Experimental

Aerobic exercise is lasting for nearly 20 minutes each time, and add resistance exercise for 20 minutes. Additional warm-up 10 minutes and stretching for 5 minutes.

Intervention: exercise (Behavioral)

Aerobic exercise combined with interval training

Experimental

Aerobic exercise is lasting for nearly 20 minutes each time, and add moderal intensity interval training for 10 minutes. Additional warm-up 10 minutes and stretching for 15 minutes.

Intervention: exercise (Behavioral)

Placebo

Placebo Comparator

No exercise intervention.

Intervention: No exercise intervention (Behavioral)

Outcomes

Primary Outcomes

visceral adipose tissue

Time Frame: time before intervention(T0) and after 12-weeks exercise intervention (T1)

measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition.

insulin resistance

Time Frame: time before intervention(T0) and after 12-weeks exercise intervention (T1)

Blood samples.Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin (μU/mL)× glucose(mmol/L)/22.5). The insulin level and fasting sugar from blood sample will be checked to calculate the insulin resistance.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yu-Hsuan Chang

Principal Investigator, Nurse, ph D student

National Taiwan University

Study Sites (1)

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