Different Order of Concurrent Training on Improving Visceral Adipose Tissue and Insulin Resistance.
Primary Purpose
Fat Burn, Aerobic Exercise, Resistance Exercise
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
aerobic exercise
resistance exercise
Sponsored by
About this trial
This is an interventional prevention trial for Fat Burn
Eligibility Criteria
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.
Sites / Locations
- Natioal Tainan Junior College of NursingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
aerobic exercise(AE) preceding resistance exercise(RE)
RE preceding AE
Control group
Arm Description
at least moderate intensity of AE 30 minutes than RE 15 minutes, with a break of 5 minutes between two modalities of training.
RE 15 minutes than at least moderate intensity of AE 30 minutes, with a break of 5 minutes between two modalities of training.
Participants maintain their usual life without any exercise intervention.
Outcomes
Primary Outcome Measures
visceral adipose tissue
Participants will measure visceral adipose tissue measure at baseline by body composition analyzer.
visceral adipose tissue
Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer.
Insulin
Participants will collect insulin at baseline by blood samples
Insulin
Participants will collect insulin after 16-week intervention by blood samples
Fasting glucose
Participants will collect fasting glucose at baseline by blood samples
Fasting glucose
Participants will collect fasting glucose after 16-week intervention by blood samples
Secondary Outcome Measures
waist circumference
Participants will measure waist circumference at baseline by tape measurement
waist circumference
Participants will measure waist circumference after 16-week intervention by tape measurement
hip circumference
Participants will measure hip circumference at baseline by tape measurement
hip circumference
Participants will measure hip circumference after 16-week intervention by tape measurement
weight
Participants will measure weight at baseline by body composition analyzer
weight
Participants will measure weight after 16-week intervention by body composition analyzer
body fat percentage
Participants will measure body fat percentage at baseline by body composition analyzer
body fat percentage
Participants will measure body fat percentage after 16-week intervention by body composition analyzer
Full Information
NCT ID
NCT05580263
First Posted
October 3, 2022
Last Updated
March 22, 2023
Sponsor
National Tainan Junior College of Nursing
1. Study Identification
Unique Protocol Identification Number
NCT05580263
Brief Title
Different Order of Concurrent Training on Improving Visceral Adipose Tissue and Insulin Resistance.
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Tainan Junior College of Nursing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fat Burn, Aerobic Exercise, Resistance Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
PI (data assessor) will be blinded for the grouping.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aerobic exercise(AE) preceding resistance exercise(RE)
Arm Type
Experimental
Arm Description
at least moderate intensity of AE 30 minutes than RE 15 minutes, with a break of 5 minutes between two modalities of training.
Arm Title
RE preceding AE
Arm Type
Experimental
Arm Description
RE 15 minutes than at least moderate intensity of AE 30 minutes, with a break of 5 minutes between two modalities of training.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants maintain their usual life without any exercise intervention.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
resistance exercise
Intervention Description
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 Outcome Measure Information:
Title
visceral adipose tissue
Description
Participants will measure visceral adipose tissue measure at baseline by body composition analyzer.
Time Frame
at baseline
Title
visceral adipose tissue
Description
Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer.
Time Frame
16-week after intervention
Title
Insulin
Description
Participants will collect insulin at baseline by blood samples
Time Frame
at baseline
Title
Insulin
Description
Participants will collect insulin after 16-week intervention by blood samples
Time Frame
16-week after intervention
Title
Fasting glucose
Description
Participants will collect fasting glucose at baseline by blood samples
Time Frame
at baseline
Title
Fasting glucose
Description
Participants will collect fasting glucose after 16-week intervention by blood samples
Time Frame
16-week after intervention
Secondary Outcome Measure Information:
Title
waist circumference
Description
Participants will measure waist circumference at baseline by tape measurement
Time Frame
at baseline
Title
waist circumference
Description
Participants will measure waist circumference after 16-week intervention by tape measurement
Time Frame
16-week after intervention
Title
hip circumference
Description
Participants will measure hip circumference at baseline by tape measurement
Time Frame
at baseline
Title
hip circumference
Description
Participants will measure hip circumference after 16-week intervention by tape measurement
Time Frame
16-week after intervention
Title
weight
Description
Participants will measure weight at baseline by body composition analyzer
Time Frame
at baseline
Title
weight
Description
Participants will measure weight after 16-week intervention by body composition analyzer
Time Frame
16-week after intervention
Title
body fat percentage
Description
Participants will measure body fat percentage at baseline by body composition analyzer
Time Frame
at baseline
Title
body fat percentage
Description
Participants will measure body fat percentage after 16-week intervention by body composition analyzer
Time Frame
16-week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Hsuan Chang, phD
Phone
01188662110600
Ext
273
Email
fiona5252@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsuan Chang, phD
Organizational Affiliation
National Tainan Junior College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Natioal Tainan Junior College of Nursing
City
Tainan
ZIP/Postal Code
700
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Hsuan Chang, phD
Phone
01188662110600
Ext
273
Email
fiona5252@hotmail.com
First Name & Middle Initial & Last Name & Degree
01188662110461 Chang, phD
Phone
01188662110600
Ext
273
Email
fiona5252@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data available on request due to privacy/ethical restrictions
Learn more about this trial
Different Order of Concurrent Training on Improving Visceral Adipose Tissue and Insulin Resistance.
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