The effect of a period of high-intensity interval training and a selected school-based exercises on plasma levels of has-miR125a-5p, CRP and lipid profile of adolescents with overweight and obesity
The aim of this study is to compare the effectivness of a period of high-intensity interval training, and selected school-based exercises on plasma level of has-miR125a-5p, CRP, and the lipid profile of children with overweight and obesity.
Design
Randomised ,clinical parallel group trial with control group
Settings and conduct
Forty-five male students aged 13-15 years from Lordegan city were selected and randomly divided based on age-related body mass index. Experimental groups participated in a 12-week and three sessions per week of exercise interventions, and the control group continued their daily activities without any exercise.
Participants/Inclusion and exclusion criteria
The participants of the study were obese/overweight boy adolescents, based on the Centers for Diseases Control and Prevention (CDC) classification.
Inclusion criteria consisted of; no medication, no history of cardiovascular disease, no regular physical activity and any complications that may affect training outcomes.
Intervention groups
The intervention groups consist of (i) Control, (ii) High-intensity interval training, and (iii) school-based exercises.
Main outcome variables
has-miR125a-5p, CRP, lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190517043611N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Vazgen Minasian
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 8066
Email address
vazgenmin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a period of high-intensity interval training and a selected school-based exercises on plasma levels of has-miR125a-5p, CRP and lipid profile of adolescents with overweight and obesity
Public title
Effectiveness of high intensity interval training on inflammatory factors and level of lipids in adolescents with overweight and obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents
Male
Overweight and obese
Exclusion criteria:
Syndromic obesity
Chronic diseases(asthma, diabetes and ...)
Psychologic disease
History of drug use
Age
From 13 years old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the University of Isfahan
Street address
University of Isfahan, Hezarjarib Ave., Isfahan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2020-11-08, 1399/08/18
Ethics committee reference number
IR.UI.REC.1399.055
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Inflammatory factors, has-miR125a-5p, CRP, and lipid profile
Timepoint
The study variables were measured before and after a12-week exercise intervention.
Method of measurement
The has-miR125a-5p evaluated by quantitative real-time polymerase chain reaction (qRT-PCR), and the lipid profile and CPR by ELISA method.
Secondary outcomes
1
Description
Body mass index, Cardiorespiratory fitness, Body fat percentage.
Timepoint
These variables measured before and after a 12-week exercise intervention.
Method of measurement
The body mass index (BMI) was calculated by dividing the weight by the square of the height in meters. The participants performed the 20m shuttle run test to measure cardiorespiratory fitness (VO2max), and to estimate body fat percentage, assessment of skinfold thickness and the Jackson and Pollock's formula was used.
Intervention groups
1
Description
The school-based exercise group program consisted of 12 weeks/three sessions per week, execution of the 20m shuttle run test as the aerobic training mode, Futsal basic skills training, playing Futsal and sit-up exercises that started 30 minutes in the first week and lasted for about 55 minutes in the last session.
Category
Lifestyle
2
Description
The exercise program of high-intensity interval training group composed of running 30s a given distance at 85-100% of maximal speed, and 30s active recovery.
Category
Lifestyle
3
Description
The control group continued their daily activities without any exercise.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Isfahan
Full name of responsible person
Vazgen Minasian
Street address
University of Isfahan, Hezarjarib Ave., Isfahan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 4245
Fax
+98 31 3668 7396
Email
v.minasian@spr.ui.ac.ir
Web page address
https://spr.ui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Rasoul Roknizade
Street address
University of Isfahan, Hezarjarib Ave., Isfahan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8175875391
Phone
+98 31 3793 4245
Email
v.minasian@spr.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
University of Isfahan, Hezarjarib Ave., Isfahan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8175875391
Phone
+98 31 3792 2577
Email
v.minasian@spr.ui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
University of Isfahan, Hezarjarib Ave., Isfahan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8175875391
Phone
+98 31 3793 4245
Email
v.minasian@spr.ui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
University of Isfahan, Hezarjarib Ave., Isfahan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8175875391
Phone
+98 31 3793 4245
Email
v.minasian@spr.ui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be made available to relevant professionals with some conditions required.
When the data will become available and for how long
Approximately 3 months after acceptance and printing of the article.
To whom data/document is available
University Academic Specialists
Under which criteria data/document could be used
The analysis and use of the data is not permitted without the written permission of the researche
From where data/document is obtainable
Please refer to the corresponding author of the article.
What processes are involved for a request to access data/document
The documentation request is received by the corresponding author's email and will be answered within 15 days.