The Effectiveness and Safety of HIIT in Overweight Male Subjects
Primary Purpose
Overweight, Overweight or Obesity
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
HIIT
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring high intensity interval training, overweight, young male
Eligibility Criteria
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)
Sites / Locations
- Fakultas Kedokteran Universitas Indonesia
- Universitas Indonesia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Intensity Interval Training
Arm Description
single arm intervention, with high intensity interval training
Outcomes
Primary Outcome Measures
cardiorespiratory fitness
VO2Max in ml/kg/minute
body mass index
weight and height combined as BMI in kg/m2
body mass index
weight and height combined as BMI in kg/m2
body mass index
weight and height combined as BMI in kg/m2
body fat mass
total fat mass in the body as percentage
body fat mass
total fat mass in the body as percentage
body fat mass
total fat mass in the body as percentage
visceral fat
body fat stored within abdominal cavity as ratings
visceral fat
body fat stored within abdominal cavity as ratings
visceral fat
body fat stored within abdominal cavity as ratings
waist circumference
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
waist circumference
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
waist circumference
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
lipid profile
total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride
antioxidant level
SOD in U/mg
free radicals level
MDA in nmol/mg
inflammation
TNF-alpha in microgram/ml
interleukin level
IL-6 nanogram/ml
Secondary Outcome Measures
Fat Burning Effect
FGF21
Myokin
Irisin
Cognitive Function Screening
Montreal Cognitive Assessment as score
Working memory Capacity
N-Back test as percentage of correct answers
Executive Function
Trail Making Test A and B as seconds
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05000437
Brief Title
The Effectiveness and Safety of HIIT in Overweight Male Subjects
Official Title
The Effectiveness and Safety of High Intensity Interval Training Based on Oxidative Stress and Inflammatory Markers in the Management of Overweight Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Overweight or Obesity
Keywords
high intensity interval training, overweight, young male
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
single arm intervention, with high intensity interval training
Intervention Type
Other
Intervention Name(s)
HIIT
Intervention Description
3x/week high intensity interval training for 12 weeks
Primary Outcome Measure Information:
Title
cardiorespiratory fitness
Description
VO2Max in ml/kg/minute
Time Frame
12 weeks
Title
body mass index
Description
weight and height combined as BMI in kg/m2
Time Frame
week 4
Title
body mass index
Description
weight and height combined as BMI in kg/m2
Time Frame
week 8
Title
body mass index
Description
weight and height combined as BMI in kg/m2
Time Frame
week 12
Title
body fat mass
Description
total fat mass in the body as percentage
Time Frame
week 4
Title
body fat mass
Description
total fat mass in the body as percentage
Time Frame
week 8
Title
body fat mass
Description
total fat mass in the body as percentage
Time Frame
week 12
Title
visceral fat
Description
body fat stored within abdominal cavity as ratings
Time Frame
week 4
Title
visceral fat
Description
body fat stored within abdominal cavity as ratings
Time Frame
week 8
Title
visceral fat
Description
body fat stored within abdominal cavity as ratings
Time Frame
week 12
Title
waist circumference
Description
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
Time Frame
week 4
Title
waist circumference
Description
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
Time Frame
week 8
Title
waist circumference
Description
circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm
Time Frame
week 12
Title
lipid profile
Description
total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride
Time Frame
12 weeks
Title
antioxidant level
Description
SOD in U/mg
Time Frame
12 weeks
Title
free radicals level
Description
MDA in nmol/mg
Time Frame
12 weeks
Title
inflammation
Description
TNF-alpha in microgram/ml
Time Frame
12 weeks
Title
interleukin level
Description
IL-6 nanogram/ml
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fat Burning Effect
Description
FGF21
Time Frame
week 1, 6, 12
Title
Myokin
Description
Irisin
Time Frame
week 1, 6, 12
Title
Cognitive Function Screening
Description
Montreal Cognitive Assessment as score
Time Frame
week 1 and 12
Title
Working memory Capacity
Description
N-Back test as percentage of correct answers
Time Frame
week 1 and 12
Title
Executive Function
Description
Trail Making Test A and B as seconds
Time Frame
week 1 and 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nani Sudarsono
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fakultas Kedokteran Universitas Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
Universitas Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
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The Effectiveness and Safety of HIIT in Overweight Male Subjects
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