Fat BurnNCT05580263
Different Order of Concurrent Training on Improving Visceral Adipose Tissue and Insulin Resistance.
A study testing aerobic exercise and resistance exercise in people with Fat Burn and Aerobic Exercise, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Burn, Aerobic Exercise, Resistance Exercise
- What is being tested?
- aerobic exercise and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Fat Burn, Aerobic Exercise, Resistance Exercise
- Being tested
- aerobic exercise, resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise(AE) preceding resistance exercise(RE) | Experimental | at least moderate intensity of AE 30 minutes than RE 15 minutes, with a break of 5 minutes between two modalities of training. Receives: Behavioral: aerobic exercise; Behavioral: resistance exercise |
| RE preceding AE | Experimental | RE 15 minutes than at least moderate intensity of AE 30 minutes, with a break of 5 minutes between two modalities of training. Receives: Behavioral: aerobic exercise; Behavioral: resistance exercise |
| Control group | No intervention | Participants maintain their usual life without any exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral adipose tissue
Participants will measure visceral adipose tissue measure at baseline by body composition analyzer.
Measured: at baseline
visceral adipose tissue
Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer.
Measured: 16-week after intervention
Insulin
Participants will collect insulin at baseline by blood samples
Measured: at baseline
Insulin
Participants will collect insulin after 16-week intervention by blood samples
Measured: 16-week after intervention
Fasting glucose
Participants will collect fasting glucose at baseline by blood samples
Measured: at baseline
Fasting glucose
Participants will collect fasting glucose after 16-week intervention by blood samples
Measured: 16-week after intervention
Secondary outcomes (8)
waist circumference
Participants will measure waist circumference at baseline by tape measurement
Measured: at baseline
waist circumference
Participants will measure waist circumference after 16-week intervention by tape measurement
Measured: 16-week after intervention
hip circumference
Participants will measure hip circumference at baseline by tape measurement
Measured: at baseline
hip circumference
Participants will measure hip circumference after 16-week intervention by tape measurement
Measured: 16-week after intervention
weight
Participants will measure weight at baseline by body composition analyzer
Measured: at baseline
weight
Participants will measure weight after 16-week intervention by body composition analyzer
Measured: 16-week after intervention
body fat percentage
Participants will measure body fat percentage at baseline by body composition analyzer
Measured: at baseline
body fat percentage
Participants will measure body fat percentage after 16-week intervention by body composition analyzer
Measured: 16-week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start31 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Tainan Junior College of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsuan Chang, National Tainan Junior College of Nursing
- Investigators
- Yu-Hsuan Chang, phD, Principal investigator, National Tainan Junior College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580263
- Sponsor's protocol ID
- 110-551
- Status last verified
- Feb 2024
- First submitted
- 3 Oct 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available on request due to privacy/ethical restrictions
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05580263
- Acronym / sponsor ID
- 110-551
- Conditions
- Fat Burn, Aerobic Exercise, Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Tainan Junior College of NursingUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise(AE) preceding resistance exercise(RE) | Experimental | Behavioral: aerobic exercise, Behavioral: resistance exerciseat least moderate intensity of AE 30 minutes than RE 15 minutes, with a break of 5 minutes between two modalities of training. |
| RE preceding AE | Experimental | Behavioral: aerobic exercise, Behavioral: resistance exerciseRE 15 minutes than at least moderate intensity of AE 30 minutes, with a break of 5 minutes between two modalities of training. |
| Control group | No intervention | –Participants maintain their usual life without any exercise intervention. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exerciseThe 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). | Behavioural | RE preceding AE, aerobic exercise(AE) preceding resistance exercise(RE) |
| resistance exerciseIn 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. | Behavioural | RE preceding AE, aerobic exercise(AE) preceding resistance exercise(RE) |
Primary outcome
visceral adipose tissue
Time frame: at baseline
Participants will measure visceral adipose tissue measure at baseline by body composition analyzer.
visceral adipose tissue
Time frame: 16-week after intervention
Participants will measure visceral adipose tissue measure after 16-week intervention by body composition analyzer.
Insulin
Time frame: at baseline
Participants will collect insulin at baseline by blood samples
Insulin
Time frame: 16-week after intervention
Participants will collect insulin after 16-week intervention by blood samples
Fasting glucose
Time frame: at baseline
Participants will collect fasting glucose at baseline by blood samples
Fasting glucose
Time frame: 16-week after intervention
Participants will collect fasting glucose after 16-week intervention by blood samples
8 secondary outcomes
waist circumference
Time frame: at baseline
waist circumference
Time frame: 16-week after intervention
hip circumference
Time frame: at baseline
hip circumference
Time frame: 16-week after intervention
weight
Time frame: at baseline
weight
Time frame: 16-week after intervention
body fat percentage
Time frame: at baseline
body fat percentage
Time frame: 16-week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No. Data available on request due to privacy/ethical restrictions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsuan Chang, phD principal investigator
National Tainan Junior College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and resistance exercise in people with Fat Burn and Aerobic Exercise, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visceral adipose tissue (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.