<?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>IRCT20220128053844N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-31</date_registration>
      <primary_sponsor>Vice-Chancellor for Research and Technology, Technical and Vocational University</primary_sponsor>
      <public_title>Effect of exercise training on obese women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of high-intensity functional training on the expression of miR-637, CRP and lipid profile levels in overweight/obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In the present study, participants were randomly assigned to two training and control groups. The control group does not receive any intervention (exercise or supplement). Blood samples are taken from the control group only in two time periods, Randomization description: Assigning samples using simple random-lottery method. In this method, first the list of names of all members is obtained. It is then assigned a number to each. It is placed inside the box. The papers are then selected and removed individually until the desired sample size is complete, Blinding description: The present study is performed in a single blind manner and the only researchers knows how to assign individuals to different groups.In general, all participants in this project are unaware of what kind of sports group they are said to be, and the researchers will individually give the exercise to individuals and will not be explained to people about the type and name of the exercise. Also, the data analyst, clinical caregiver, outcome assessor, as well as the safety committee and data monitoring will not know how to assign exercise.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Eight weeks of high-intensity interval training (HIFT). Subjects will participate in high-intensity functional training (HIFT) 3-4 days a week for 8 weeks. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session. The duration of the study period will be 2 months (equal to 8 weeks). Intervention 2: Control group: Control group: In this group, we will not have any exercise or drug intervention. Blood samples will be taken from the subjects in two stages (48 hours before the start of the research study and 48 hours after the last day of the research period). The duration of the study period will be 2 months (equal to 8 weeks).</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:
In the meetings that will be held with the participants before and after the study, all the data and their analysis, consent and trial and study protocol will be explained to them.

When:
Depending on the variable, the data of some variables will be accessed before the start of the research and others after the end of the research.

To whom:
Project participants, researchers and university professors

Conditions:
Other researchers will be allowed to access the data in order to use and assist other researchers and to commit not to misuse the data.

Where to obtain:
Email - In-person visit

How to obtain:
Provide identification documents and research resume and provide commitment in order not to misuse the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza zolfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Technical and Vocational University. Manzariyeh,Tabriz,East Azerbaijan Province.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۱۷۴۹۱۳۱۳۶</zip>
        <telephone>+98 41 3477 9011</telephone>
        <email>Hamidreza.zolfi@yahoo.com</email>
        <affiliation>East Azarbaijan Technical and Vocational University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Reza Zolfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Technical and Vocational University of East Azarbaijan, Manzariyeh, Tabriz, East Azarbaijan</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۱۷۴۹۱۳۱۳۶</zip>
        <telephone>+98 41 3477 9011</telephone>
        <email>hzolfi@tabrizu.ac.ir</email>
        <affiliation>Technical and Vocational University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 35 to 45 years
Body mass index 25 to 35</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Smoking
Taking certain medications to control body weight and blood pressure during the last three months
Diastolic and systolic pressures greater than 100 and 140 mm Hg, respectively
having neuromuscular diseases as well as cardio-respiratory diseases.
Having cardiorespiratory diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Eight weeks of high-intensity interval training (HIFT). Subjects will participate in high-intensity functional training (HIFT) 3-4 days a week for 8 weeks. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session. The duration of the study period will be 2 months (equal to 8 weeks).</i_keyword>
      <i_keyword>Control group: Control group: In this group, we will not have any exercise or drug intervention. Blood samples will be taken from the subjects in two stages (48 hours before the start of the research study and 48 hours after the last day of the research period). The duration of the study period will be 2 months (equal to 8 weeks).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of micro RNA 637 (miR-637). Timepoint: Before and after starting eight weeks of HIFT training. Method of measurement: Real-Time PCR and using PCR mic.</prim_outcome>
      <prim_outcome>The level of C-Reactive Protein (CRP). Timepoint: Before and after starting eight weeks of HIFT training. Method of measurement: It will be measured by Elisa Reader method with high sensitivity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid profile. Timepoint: Before and after the start of research. Method of measurement: Using the kit of Pars Azmoun company and with the sensitivity of the kit, 5 mg/dl will be measured.</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>Technical and Vocational University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-02</approval_date>
        <contact_name>Ethics Committee of Research Institute of Movement Sciences</contact_name>
        <contact_address>KhU, No. 43. South Mofatteh Ave., Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
