The Effectiveness and Safety of HIIT in Overweight Male Subjects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
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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.
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Sample size assessment is measured from 5 primary output by a research assistants using sample size calculation website for single intervention clinical trial.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Intensity Interval Training single arm intervention, with high intensity interval training |
Other: HIIT
3x/week high intensity interval training for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- cardiorespiratory fitness [12 weeks]
VO2Max in ml/kg/minute
- body mass index [week 4]
weight and height combined as BMI in kg/m2
- body mass index [week 8]
weight and height combined as BMI in kg/m2
- body mass index [week 12]
weight and height combined as BMI in kg/m2
- body fat mass [week 4]
total fat mass in the body as percentage
- body fat mass [week 8]
total fat mass in the body as percentage
- body fat mass [week 12]
total fat mass in the body as percentage
- visceral fat [week 4]
body fat stored within abdominal cavity as ratings
- visceral fat [week 8]
body fat stored within abdominal cavity as ratings
- visceral fat [week 12]
body fat stored within abdominal cavity as ratings
- waist circumference [week 4]
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
- waist circumference [week 8]
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
- waist circumference [week 12]
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
- lipid profile [12 weeks]
total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride
- antioxidant level [12 weeks]
SOD in U/mg
- free radicals level [12 weeks]
MDA in nmol/mg
- inflammation [12 weeks]
TNF-alpha in microgram/ml
- interleukin level [12 weeks]
IL-6 nanogram/ml
Secondary Outcome Measures
- Fat Burning Effect [week 1, 6, 12]
FGF21
- Myokin [week 1, 6, 12]
Irisin
- Cognitive Function Screening [week 1 and 12]
Montreal Cognitive Assessment as score
- Working memory Capacity [week 1 and 12]
N-Back test as percentage of correct answers
- Executive Function [week 1 and 12]
Trail Making Test A and B as seconds
Eligibility Criteria
Criteria
Inclusion Criteria:
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overweight (BMI 25 - 29,9)
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live in Jakarta and greater area
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willing to participate
Exclusion Criteria:
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smoking
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any medical health problems (epilepsy, cardiovascular disease, kidney and liver problems, history of fractures, tendon and ligament injuries)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fakultas Kedokteran Universitas Indonesia | Jakarta Pusat | DKI Jakarta | Indonesia | 10430 |
| 2 | Universitas Indonesia | Jakarta Pusat | DKI Jakarta | Indonesia | 10430 |
Sponsors and Collaborators
- Indonesia University
Investigators
- Principal Investigator: Nani Sudarsono, Fakultas Kedokteran Universitas Indonesia
Study Documents (Full-Text)
More Information
Publications
None provided.- 20-09-1081