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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05580263
Other study ID # 110-551
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2022
Est. completion date June 30, 2023

Study information

Verified date February 2024
Source National Tainan Junior College of Nursing
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 64 Years
Eligibility 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 Design


Intervention

Behavioral:
aerobic exercise
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
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.

Locations

Country Name City State
Taiwan Natioal Tainan Junior College of Nursing Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Tainan Junior College of Nursing

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary visceral adipose tissue Participants will measure visceral adipose tissue measure at baseline by body composition analyzer. at baseline
Primary visceral adipose tissue Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer. 16-week after intervention
Primary Insulin Participants will collect insulin at baseline by blood samples at baseline
Primary Insulin Participants will collect insulin after 16-week intervention by blood samples 16-week after intervention
Primary Fasting glucose Participants will collect fasting glucose at baseline by blood samples at baseline
Primary Fasting glucose Participants will collect fasting glucose after 16-week intervention by blood samples 16-week after intervention
Secondary waist circumference Participants will measure waist circumference at baseline by tape measurement at baseline
Secondary waist circumference Participants will measure waist circumference after 16-week intervention by tape measurement 16-week after intervention
Secondary hip circumference Participants will measure hip circumference at baseline by tape measurement at baseline
Secondary hip circumference Participants will measure hip circumference after 16-week intervention by tape measurement 16-week after intervention
Secondary weight Participants will measure weight at baseline by body composition analyzer at baseline
Secondary weight Participants will measure weight after 16-week intervention by body composition analyzer 16-week after intervention
Secondary body fat percentage Participants will measure body fat percentage at baseline by body composition analyzer at baseline
Secondary body fat percentage Participants will measure body fat percentage after 16-week intervention by body composition analyzer 16-week after intervention
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