<?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>IRCT20210626051720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-11</date_registration>
      <primary_sponsor>University of Tehran</primary_sponsor>
      <public_title>The effect of endurance, resistance and combination training on some inflammatory mediators in obese women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of endurance, resistance and combined training (resistance-endurance) on the levels of Pentraxin 3, Galectin 3 and some inflammatory mediators in obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57100</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Other design features: This study is a randomized factorial clinical trial. The target population includes 48 obese women in Tehran. People will be divided into four groups of 12 people, Randomization description: Using the lottery method
The names of the subjects are written on 40 separate pieces of paper and placed in a container. The names of the subjects are then randomly extracted and placed in the intervention or placebo group. The first 30 names are in the intervention group and the rest are in the placebo group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 12 obese women without regular exercise. Intervention 2: Intervention group: Endurance exercise (performed by 12 obese women for 12 weeks and 3 sessions per week, 30 minutes on a treadmill with 60% heart rate) is performed before and after exercise for 15 minutes, warming up and cooling down, respectively. Intervention 3: Intervention group: Resistance training (will be performed by 12 obese women for 12 weeks and 3 sessions per week. Each resistance training session will be about 30 minutes, which will include four sets with 8-12 repetitions and 10RM intensity, which includes leg presses, forward leg movements, Sit on the back of the foot, chest press and paddle.) Warm up and cool down for 15 minutes before and after exercise, respectively.10RM is approximately equal to 75% of 1RM. Intervention 4: Intervention group: Combined exercise (endurance-resistance) :( will be performed by 12 obese women for 12 weeks and 3 sessions per week. The combined exercise program in each session will include 15 minutes of aerobic exercise and 15 minutes of resistance exercise (two sets for each movement) .) Warm up and cool down for 15 minutes before and after training, respectively.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kooti Mahrokh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14, Behesh Asa alley, Shariati, Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911861021</zip>
        <telephone>+98 21 2211 1449</telephone>
        <email>kooti.mahrokh@gmail.com</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soori Rahman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirabad Street, in front of the university dormitory</address>
        <city>Teran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417935840</zip>
        <telephone>+98 21 8835 1740</telephone>
        <email>soori@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight women with a body mass index above 30
No history of regular physical activity in the past year
Having a general level of physical and mental health</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having type 2 diabetes
Cardiovascular diseases
Drug or alcohol addiction</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 12 obese women without regular exercise</i_keyword>
      <i_keyword>Intervention group: Endurance exercise (performed by 12 obese women for 12 weeks and 3 sessions per week, 30 minutes on a treadmill with 60% heart rate) is performed before and after exercise for 15 minutes, warming up and cooling down, respectively.</i_keyword>
      <i_keyword>Intervention group: Resistance training (will be performed by 12 obese women for 12 weeks and 3 sessions per week. Each resistance training session will be about 30 minutes, which will include four sets with 8-12 repetitions and 10RM intensity, which includes leg presses, forward leg movements, Sit on the back of the foot, chest press and paddle.) Warm up and cool down for 15 minutes before and after exercise, respectively.10RM is approximately equal to 75% of 1RM.</i_keyword>
      <i_keyword>Intervention group: Combined exercise (endurance-resistance) :( will be performed by 12 obese women for 12 weeks and 3 sessions per week. The combined exercise program in each session will include 15 minutes of aerobic exercise and 15 minutes of resistance exercise (two sets for each movement) .) Warm up and cool down for 15 minutes before and after training, respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pentraxine 3. Timepoint: First, the end of the study. Method of measurement: Kit Eliza.</prim_outcome>
      <prim_outcome>Galactin 3. Timepoint: First, the end of the study. Method of measurement: Kit Eliza.</prim_outcome>
      <prim_outcome>Tumor necrosis factor-a (TNF-a). Timepoint: First, the end of the study. Method of measurement: Kit Eliza.</prim_outcome>
      <prim_outcome>Serum Amyloid A (SAA). Timepoint: First, the end of the study. Method of measurement: Kit Eliza.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin. Timepoint: First, the end of the study. Method of measurement: Insulin Eliza Kit.</sec_outcome>
      <sec_outcome>Glucose. Timepoint: First, the end of the study. Method of measurement: Glucose Assessment Kit.</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>University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-14</approval_date>
        <contact_name>Ethics Committee of the Faculty of Physical Education and Sports Sciences, University of Tehran</contact_name>
        <contact_address>Thirteenth floor, Block A, Central headquarters of the Ministry of Health, Qads town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
