<?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>IRCT20201108049299N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-06</date_registration>
      <primary_sponsor>The University of Tehran</primary_sponsor>
      <public_title>The effect of two types of exercise on some predictors of cardiovascular status in overweight men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of high intensity interval and continuous training on galectin 3, GDF15, NT-ProBNP and IL6 in overweight men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52162</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple Random.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: High intensity interval training with three sessions of interval training protocol each week for eight weeks. Intervention 2: Intervention group 2: Continuous training that performed three sessions of continuous training protocol every eight weeks. Intervention 3: Control group:  did not have any exercise activities during the study.</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:
Sample data can be shared on average in a table

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
To use data for research work

Where to obtain:
University of Tehran Faculty of Physical Education    infosport@ut.ac.ir http://www.sport.ut.ac.ir      02188351730

How to obtain:
Refer to the library unit of the Faculty of Physical Education, University of Tehran

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 25 Yakhchal Ave., Sheikh Shahab Blvd</address>
        <city>Ahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451777485</zip>
        <telephone>+98 41 4422 9447</telephone>
        <email>m.moradi13@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 25, Yakhchal Ave., Sheikh Shahab Blvd., Ahar</address>
        <city>Ahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451777485</zip>
        <telephone>+98 41 4422 9447</telephone>
        <email>m.moradi13@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range between 23 and 28
BMI between 25 and 30
Male gender</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>28 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>No history of known cardiovascular, hepatic, renal, pulmonary and diabetic diseases, hypothyroidism
No serious physical injury and orthopedics
Do not take food and medicine supplements
no regular exercise in the year leading up to the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight</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 1: High intensity interval training with three sessions of interval training protocol each week for eight weeks.</i_keyword>
      <i_keyword>Intervention group 2: Continuous training that performed three sessions of continuous training protocol every eight weeks.</i_keyword>
      <i_keyword>Control group:  did not have any exercise activities during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Galectin 3. Timepoint: Two days before the start of the study and two days after the end of the study (eight weeks of study). Method of measurement: Blood draw from arm vein and laboratory kit of galectin 3.</prim_outcome>
      <prim_outcome>Interleukin 6. Timepoint: Two days before the start of the study and two days after the end of the study (eight weeks of study). Method of measurement: Blood draw from arm vein and laboratory kit of Interleukin6.</prim_outcome>
      <prim_outcome>NT-ProB-Type Natriuretic Peptide (BNP). Timepoint: Two days before the start of the study and two days after the end of the study (eight weeks of study). Method of measurement: Blood draw from arm vein and laboratory kit of NT-ProBNP.</prim_outcome>
      <prim_outcome>Growth Differentiation Factor-15 (GDF15). Timepoint: Two days before the start of the study and two days after the end of the study (eight weeks of study). Method of measurement: Blood draw from arm vein and laboratory kit of GDF15.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>personal expenses</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-15</approval_date>
        <contact_name>Ethics Committee of Tehran University</contact_name>
        <contact_address>No. 25, Yakhchal Ave., Sheikh shahab Blvd. Ahar East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
