<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200116046154N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-11</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <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</public_title>
      <acronym></acronym>
      <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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anti-Atherosclerosis Effects of exercise.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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. Intervention 3: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The individual data of the study participants are shared after unidentifiable individuals are identified

When:
Two month

To whom:
Researchers

Conditions:
For the sake of transparency and researcher satisfaction

Where to obtain:
Alireza Paahoo

How to obtain:
Request and send to researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Tadibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room no.67, Faculty of Physical Education and Sport Sciences, Razi University, Zakariya Razi Blvd.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 9265</telephone>
        <email>vtadibi@yahoo.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Tadibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room no.67, Faculty of Physical Education and Sport Sciences, Razi University, Zakariya Razi Blvd.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 9265</telephone>
        <email>vtadibi@yahoo.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <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.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Salusin-α. Timepoint: Pre and Post test. Method of measurement: Blood sampling and laboratory kit.</prim_outcome>
      <prim_outcome>Salusin-β. Timepoint: Pre and Post test. Method of measurement: Blood sampling and laboratory kit.</prim_outcome>
      <prim_outcome>Nitric oxide. Timepoint: Pre and Post test. Method of measurement: Blood sampling and laboratory kit.</prim_outcome>
      <prim_outcome>Interleukin-6. Timepoint: Pre and Post test. Method of measurement: Blood sampling and laboratory kit.</prim_outcome>
      <prim_outcome>C-reactive protein. Timepoint: Pre and Post test. Method of measurement: Blood sampling and laboratory kit.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Pre and Post test. Method of measurement: Blood sampling and laboratory kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Razi University</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Razi University</source_name>
      <source_name>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-30</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
