The Effectiveness and Safety of HIIT in Overweight Male Subjects

Study Overview
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Brief Summary
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Increased prevalence of overweight and obesity is one of the main health problems recently. Energy balance from nutrition intake and energy expenditure through physical activity, especially structured physical activity, is needed to prevent overweight individuals become obese individuals. This research objective is to explore the effectiveness and safety of structured high intensity interval training in male young adults subjects with overweight based on change of body composition, oxidative stress and inflammatory markers. This research used experimental model to test structured high intensity interval training program with pre-post test in single group. Comprehensive analysis of training effect in this research consists of measurement of several parameters, such as body composition, inflammatory markers, and oxidative stress markers as the benchmark of training safety. Browning white adipose tissue and cognitive function are complement parameters to the assessment of training effectiveness. Daily food record and physical activity for 3 x 24 hours will be carried out periodically to control confounding factors.

Detailed Description
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Subjects are recruited via e-flyer distributed online across university departments. Individual who is interested in study participation fills out screening form. Research assistants screen subjects eligibility. Subjects are coded based on the order of screening form fulfillment. Research assistants are using the standard operational procedures for each assessments. Training for the research assistants precedes the data collection to ensure the similarity of understanding and skills during measurements. One research assistant responsible for scheduling the assessments and training sessions. Continuous evaluation are planned weekly to provide room for improvements in the process of data collection. Sample size assessment is measured from 5 primary output by a research assistants using sample size calculation website for single intervention clinical trial. Investigator use paper based data collection for each assessment and during training sessions. Subject are encouraged to report any symptoms and signs during intervention period in each meeting with the research assistants or via online messaging. Any reports will be documented in separated form. One research assistant makes sure the data fields are completed in each measurements and during training sessions. The assistant also check the similarity of the data entered in the master table. Data analysis will be lead by one research assistant using newest version of SPSS software. The analysis will be started after the baseline measurement is completed although the data collection is not finished. All numeric data will be presented as mean and standard deviations if normally distributed or median and minimum maximum range if not normally distributed. Paired t-test will be used to identify the difference before and after the intervention if the data are normally distributed. If the data are not normally distributed, Wilcoxon test will be used to identify the difference before and after the intervention. To ensure that there is no missing data, the research assistant who responsible for data completeness will perform daily checking. Any missing data will be stated and immediately completed. Research assistants will provide close supervision for each subject to ensure the delivery of all necessary reports.

Official Title
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The Effectiveness and Safety of High Intensity Interval Training Based on Oxidative Stress and Inflammatory Markers in the Management of Overweight Male Subjects

Conditions
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Overweight, Overweight or Obesity

Intervention / Treatment
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* Other: HIIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight (BMI 25 - 29,9) live in Jakarta and greater area willing to participate Exclusion Criteria: smoking any medical health problems (epilepsy, cardiovascular disease, kidney and liver problems, history of fractures, tendon and ligament injuries)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training<br>single arm intervention, with high intensity interval training | Other: HIIT<br>* 3x/week high intensity interval training for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiorespiratory fitness | VO2Max in ml/kg/minute | 12 weeks | 
| body mass index | weight and height combined as BMI in kg/m2 | week 4 | 
| body mass index | weight and height combined as BMI in kg/m2 | week 8 | 
| body mass index | weight and height combined as BMI in kg/m2 | week 12 | 
| body fat mass | total fat mass in the body as percentage | week 4 | 
| body fat mass | total fat mass in the body as percentage | week 8 | 
| body fat mass | total fat mass in the body as percentage | week 12 | 
| visceral fat | body fat stored within abdominal cavity as ratings | week 4 | 
| visceral fat | body fat stored within abdominal cavity as ratings | week 8 | 
| visceral fat | body fat stored within abdominal cavity as ratings | week 12 | 
| waist circumference | circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm | week 4 | 
| waist circumference | circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm | week 8 | 
| waist circumference | circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm | week 12 | 
| lipid profile | total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride | 12 weeks | 
| antioxidant level | SOD in U/mg | 12 weeks | 
| free radicals level | MDA in nmol/mg | 12 weeks | 
| inflammation | TNF-alpha in microgram/ml | 12 weeks | 
| interleukin level | IL-6 nanogram/ml | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Burning Effect | FGF21 | week 1, 6, 12 | 
| Myokin | Irisin | week 1, 6, 12 | 
| Cognitive Function Screening | Montreal Cognitive Assessment as score | week 1 and 12 | 
| Working memory Capacity | N-Back test as percentage of correct answers | week 1 and 12 | 
| Executive Function | Trail Making Test A and B as seconds | week 1 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high intensity interval training, overweight, young male