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Completed

NCT Number: NCT05580263

Different Order of Concurrent Training on Improving Visceral Adipose Tissue and Insulin Resistance.

Purposes: The purpose of one-year project is to compare the effect of different intrasession exercise order of AE and RE during concurrent training on reducing VAT and improving insulin resistance for inactive middle-age community residents with obesity.

Methods: Purposive sampling will be used to enroll community residents aged 40-64 years with inactive habit and body fat percentage ≧ 25% for male and ≧ 30% for female in southern Taiwan. Eligible participants will be stratified by sex and age (40-55years and 56-64 years) then block randomly divided into training group of AE preceding RE, RE preceding AE or a control group. The exercise training program will under supervision lasting 16 weeks with 3 times per week. The concurrent training prescription consist of AE 30 minutes and RE 15 minutes per session. A 5-minute interval between two exercise modalities. All participants will be evaluated outcomes for two time points including baseline (T0) and after 16-week intervention (T1). The primary outcomes are VAT and insulin resistance. A two-way ANOVA with repeated measures will be performed to compare changes of outcome variables over the intervention period.

Relevance to clinical practice: The results of this project can assist health professionals to know how to properly prescribe concurrent training of AE and RE to achieve the greatest effects on VATreduction and insulin resistance improvement for middle-age residents with obesity.

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Key information

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Natioal Tainan Junior College of Nursing

Tainan, 700, Taiwan

About this study

Background: Visceral adipose tissue (VAT) accumulation is highly linking with cardiovascular diseases and insulin resistance. A combination of aerobic exercise (AE) and resistance exercise (RE) was an effective strategy to improve VAT and insulin resistance; however, no current evidence displayed whether the different orders of concurrent training (AE preceding RE or RE preceding AE) influence the effects on VAT reduction and insulin resistance improvement.

Purposes: The purpose of one-year project is to compare the effect of different intrasession exercise order of AE and RE during concurrent training on reducing VAT and improving insulin resistance for inactive middle-age community residents with obesity.

Methods: Purposive sampling will be used to enroll community residents aged 40-64 years with inactive habit and body fat percentage ≧ 25% for male and ≧ 30% for female in Tainan. Eligible participants will be stratified by sex and age (40-55years and 56-64 years) then block randomly divided into training group of AE preceding RE, RE preceding AE or a control group. The exercise training program will under supervision lasting 16 weeks with 3 times per week. The concurrent training prescription consist of AE 30 minutes and RE 15 minutes per session. A 5-minute interval between two exercise modalities. The control group will follow their primary lifestyle without exercise intervention. All participants will be evaluated outcomes for two time points including baseline (T0) and after 16-week intervention (T1). The primary outcomes are VAT and insulin resistance. VAT is measured by body composition analyzer and insulin resistance is calculate from fasting glucose and insulin level in blood samples. A two-way ANOVA with repeated measures will be performed to compare changes of outcome variables over the intervention period.

Relevance to clinical practice: The results of this project can assist health professionals to know how to properly prescribe concurrent training of AE and RE to achieve the greatest effects on VATreduction and insulin resistance improvement for middle-age residents with obesity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40 to 64 years old.
  • body fat percentage ≧ 25% for male and ≧ 30% for female.
  • with inactive habit (≤ 3 days of physical activity per week and ≤ 30 min per session).
  • can communicate in Mandarin or Taiwanese.

Exclusion criteria

  • with recent unstable conditions in which had potential risk on exercise including stroke, cardiovascular and respiratory diseases, handicap, pregnancy.
  • with any contraindications to body composition analyzer measurement including body embed pacemakers and artificial metal joints, amputated hands or feet.
  • cannot corporate with either examination or intervention.
  • use psychotropic or appetite-regulating medicine.
  • under oral hopoglycemic agent or insulin treatment.

Treatment and study plan

Aerobic Exercise

Behavioral

The main AE program will be designed and controlled for at least moderate intensity of heart rate reserve (HRR) lasting 30 minutes. The goal of intensity will be set at least 40% of HRR during the first two weeks, and then progressively increase the targeted intensity at the end of 16 weeks with 60% HRR. The motions will design by involving core muscle training (e.g., march, step touch, lunge, V-step, box step, twist, knee up, scoop, and scissors).

Resistance exercise

Behavioral

In the process, the participants will be instructed by resisting the weight smoothly, and peaking at hold. RE prescription consist of 2-4 sets with 10-15 repetitions per set with a rest interval of 1-2 minutes between sets to improve muscular fitness.

The first two weeks will start with two sets of 10-15 repetitions and then gradually progress on four sets of 15 repetitions at the end of 16 weeks. The total duration of RE will lasting around 15 minutes.

Primary outcomes

  1. visceral adipose tissue

    Time frame: at baseline

    Participants will measure visceral adipose tissue measure at baseline by body composition analyzer.

  2. visceral adipose tissue

    Time frame: 16-week after intervention

    Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer.

  3. Insulin

    Time frame: at baseline

    Participants will collect insulin at baseline by blood samples

  4. Insulin

    Time frame: 16-week after intervention

    Participants will collect insulin after 16-week intervention by blood samples

  5. Fasting glucose

    Time frame: at baseline

    Participants will collect fasting glucose at baseline by blood samples

  6. Fasting glucose

    Time frame: 16-week after intervention

    Participants will collect fasting glucose after 16-week intervention by blood samples

Secondary outcomes

  1. waist circumference

    Time frame: at baseline

    Participants will measure waist circumference at baseline by tape measurement

  2. waist circumference

    Time frame: 16-week after intervention

    Participants will measure waist circumference after 16-week intervention by tape measurement

  3. hip circumference

    Time frame: at baseline

    Participants will measure hip circumference at baseline by tape measurement

  4. hip circumference

    Time frame: 16-week after intervention

    Participants will measure hip circumference after 16-week intervention by tape measurement

  5. weight

    Time frame: at baseline

    Participants will measure weight at baseline by body composition analyzer

  6. weight

    Time frame: 16-week after intervention

    Participants will measure weight after 16-week intervention by body composition analyzer

  7. body fat percentage

    Time frame: at baseline

    Participants will measure body fat percentage at baseline by body composition analyzer

  8. body fat percentage

    Time frame: 16-week after intervention

    Participants will measure body fat percentage after 16-week intervention by body composition analyzer

Sponsors and collaborators

Lead sponsor

National Tainan Junior College of Nursing

Other

Registry information

Official study title

The Effect of Different Order of Concurrent Training Consisting Aerobic and Resistance Exercise on Improving Visceral Adipose Tissue and Insulin Resistance for Community Residents With Obesity.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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