- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580263
Different Order of Concurrent Training on Improving Visceral Adipose Tissue and Insulin Resistance.
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tainan, Taiwan, 700
- Natioal Tainan Junior College of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aerobic exercise(AE) preceding resistance exercise(RE)
at least moderate intensity of AE 30 minutes than RE 15 minutes, with a break of 5 minutes between two modalities of training.
|
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).
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. |
Experimental: RE preceding AE
RE 15 minutes than at least moderate intensity of AE 30 minutes, with a break of 5 minutes between two modalities of training.
|
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).
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. |
No Intervention: Control group
Participants maintain their usual life without any exercise intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visceral adipose tissue
Time Frame: at baseline
|
Participants will measure visceral adipose tissue measure at baseline by body composition analyzer.
|
at baseline
|
visceral adipose tissue
Time Frame: 16-week after intervention
|
Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer.
|
16-week after intervention
|
Insulin
Time Frame: at baseline
|
Participants will collect insulin at baseline by blood samples
|
at baseline
|
Insulin
Time Frame: 16-week after intervention
|
Participants will collect insulin after 16-week intervention by blood samples
|
16-week after intervention
|
Fasting glucose
Time Frame: at baseline
|
Participants will collect fasting glucose at baseline by blood samples
|
at baseline
|
Fasting glucose
Time Frame: 16-week after intervention
|
Participants will collect fasting glucose after 16-week intervention by blood samples
|
16-week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
waist circumference
Time Frame: at baseline
|
Participants will measure waist circumference at baseline by tape measurement
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at baseline
|
waist circumference
Time Frame: 16-week after intervention
|
Participants will measure waist circumference after 16-week intervention by tape measurement
|
16-week after intervention
|
hip circumference
Time Frame: at baseline
|
Participants will measure hip circumference at baseline by tape measurement
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at baseline
|
hip circumference
Time Frame: 16-week after intervention
|
Participants will measure hip circumference after 16-week intervention by tape measurement
|
16-week after intervention
|
weight
Time Frame: at baseline
|
Participants will measure weight at baseline by body composition analyzer
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at baseline
|
weight
Time Frame: 16-week after intervention
|
Participants will measure weight after 16-week intervention by body composition analyzer
|
16-week after intervention
|
body fat percentage
Time Frame: at baseline
|
Participants will measure body fat percentage at baseline by body composition analyzer
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at baseline
|
body fat percentage
Time Frame: 16-week after intervention
|
Participants will measure body fat percentage after 16-week intervention by body composition analyzer
|
16-week after intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yu-Hsuan Chang, phD, National Tainan Junior College of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110-551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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