Anti-atherosclerosis effects of 12 weeks high intensity interval and aerobic training on serum levels salusin-α and -β, nitric oxide, inflammatory markers and lipid profile in overweight and obese childrens
Anti-atherosclerosis effects of 12 weeks high intensity interval and aerobic training on serum levels salusin-α and -β, nitric oxide, inflammatory markers and lipid profile in overweight and obese childrens
Design
At first, considering the importance of the subject, obtaining the necessary permits from the department of education and the necessary coordination was randomly accessed by 20 schools from city-wide schools and surveying the inclusion criteria of 120 students (9-12 years). Subjects were invited to participate in the study, then a consent form, a medical history questionnaire and a physician referral form were presented to the subjects. Forty-five of them, with the consent of their parents and the student, participated in the study.
Settings and conduct
Subjects were randomly assigned to a HIIT group (n= 15) that trained at %100-110 MAS; an aerobic group (n= 15) who trained at %40-70 HRR and a control group without exercise. Exercise groups (aerobic and HIIT) trained 3 sessions per week on non-consecutive days according to their training protocols for 12 weeks. Training sessions included three parts: Standard warm-up section, main body of exercise and cooling part at end of training session.
Participants/Inclusion and exclusion criteria
Children 9 to 12 years old
Intervention groups
Three groups of high intensity training, aerobic exercise and control
Main outcome variables
Salusin-α; Salusin-β; Nitric oxide; Interleukin-6 and Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200116046154N1
Registration date:2020-02-11, 1398/11/22
Registration timing:retrospective
Last update:2020-02-11, 1398/11/22
Update count:0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Alireza Paahoo
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 83 4522 9563
Email address
paahoo.alireza@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2018-08-23, 1397/06/01
Trial completion date
2018-08-23, 1397/06/01
Scientific title
Anti-atherosclerosis effects of 12 weeks high intensity interval and aerobic training on serum levels salusin-α and -β, nitric oxide, inflammatory markers and lipid profile in overweight and obese childrens
Public title
Anti-atherosclerosis effects of 12 weeks high intensity interval and aerobic training on serum levels salusin-α and -β, nitric oxide, inflammatory markers and lipid profile in overweight and obese childrens
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 9 to 12 years
Body mass index between 19.1-26.2
No drug treatment
ِNO chronic diseases such as diabetes, metabolic syndrome (systolic blood pressure 130 mm Hg or diastolic blood pressure 85 mm Hg, waist circumference greater than 102 cm and fasting glucose 110 mm Hg), hormone, orthopedic
Not participating in any regular training program (except for exercise ring) within 6 months prior to entering the study
The subjects must be boys
Exclusion criteria:
Voluntary withdrawal by participants for any reason.
Acute infectious diseases such as influenza during research.
Two consecutive absentee sessions and three non-consecutive sessions during the time of the research run.
Acute Injury Due to Practice During Research.
Age
From 9 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Forty-five subjects from 20 schools participated in the study and were randomly divided into 3 groups of HIIT, aerobic and control groups.
Randomization of the study groups was performed using simple or unlimited randomization by using dice such that the numbers 1 and 2 for the first group, 3 and 4 for the second group, and 5 and 6 for the third group were considered. Were taken.
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
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.KUMS.REC.1397.936
Health conditions studied
1
Description of health condition studied
Anti-Atherosclerosis Effects of exercise
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
salusin-α
Timepoint
Pre and Post test
Method of measurement
Blood sampling and laboratory kit
2
Description
salusin-β
Timepoint
Pre and Post test
Method of measurement
Blood sampling and laboratory kit
3
Description
Nitric oxide
Timepoint
Pre and Post test
Method of measurement
Blood sampling and laboratory kit
4
Description
Interleukin-6
Timepoint
Pre and Post test
Method of measurement
Blood sampling and laboratory kit
5
Description
C-reactive protein
Timepoint
Pre and Post test
Method of measurement
Blood sampling and laboratory kit
6
Description
Lipid profile
Timepoint
Pre and Post test
Method of measurement
Blood sampling and laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A briefing was held to familiarize children with the exercise protocol and to measure anthropometric parameters such as height, weight, body mass index, waist and hip circumference, subcutaneous fat thickness. Twenty-four hours after the briefing session, a field test for children or a shuttle ride test was performed to measure aerobic fitness and maximal aerobic speed. 72 hours after the shuttle test, the first blood sample was taken at 7:30 am to 8 am after 12 hours in fasting HIIT subjects to measure the components of the study. 48 hours after blood sampling in the HIIT subjects according to their intended severity and their specific distances obtained by calculating their maximum aerobic velocity and determined by the cones for each subject separately, 100 to 120% of maximal aerobic speed were trained 3 times a week for 12 weeks.
Category
N/A
2
Description
Intervention group: A briefing was held to familiarize children with the exercise protocol and to measure anthropometric parameters such as height, weight, body mass index, waist and hip circumference, subcutaneous fat thickness. Twenty-four hours after the briefing session, a field test for children or a shuttle run test was performed to measure aerobic fitness and maximal aerobic speed. 72 hours after the shuttle test, the first blood samples were taken at 7:30 am to 8 am after 12 hours of fasting in the aerobic exercise group to measure the components of the study. 48 hours after blood sampling, aerobic group subjects were also warmed up and stretched according to the intensity and duration of the study, based on 40-70% of heart rate reserve 3 sessions per week. They practiced for 12 weeks.
Category
N/A
3
Description
Control group: A briefing was held to familiarize children with the exercise protocol and to measure anthropometric parameters such as height, weight, body mass index, waist and hip circumference, subcutaneous fat thickness. 72 hours after the briefing, the first blood sample was taken at 7:30 am to 8 am after 12 hours in the fasting state of the control group to measure the research components. The control group continued their normal routine throughout the 12 weeks of the study, and was advised not to engage in any organized exercise.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Alireza Paahoo
Street address
Shahid Nazari St.
City
Eslamabad-e Gharb
Province
Kermanshah
Postal code
6761935817
Phone
+98 83 4522 9563
Email
alirezapaaho@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Street address
Room no.67, Faculty of Physical Education and Sport Sciences, Razi University, Zakariya Razi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzad Veysi
Street address
Zakariya Razi Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
veysi@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
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
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Room no.67, Faculty of Physical Education and Sport Sciences, Razi University, Zakariya Razi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Room no.67, Faculty of Physical Education and Sport Sciences, Razi University, Zakariya Razi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Alireza Paahoo
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
St, Shaid Nazari
City
Eslamabad-e Gharb
Province
Kermanshah
Postal code
6761935817
Phone
+98 83 4522 9563
Email
alirezapaaho@yahoo.com
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 individual data of the study participants are shared after unidentifiable individuals are identified
When the data will become available and for how long
Two month
To whom data/document is available
Researchers
Under which criteria data/document could be used
For the sake of transparency and researcher satisfaction
From where data/document is obtainable
Alireza Paahoo
What processes are involved for a request to access data/document