<?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>IRCT20150531022498N26</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of concurrent aerobic-resistance training in girls with hypothyroidism</public_title>
      <acronym></acronym>
      <scientific_title>The effect of concurrent aerobic-resistance training on T4 , TSH, blood lipids, leptin, cortisol, blood glucose homeostasis, and physical fitness in girls with hypothyroidism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33676</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Subjects were divided into 2 groups (one control group and one experimental groups) using the simple random method. This sampling will be done based on the red and blue balls inside the box that are randomly taken by the subjects (Red Orb and the Blue Orb of the experimental group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypothyroidism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Eight weeks of concurrent resistance and aerobic exercises with 3 sessions per week will be done. Aerobic exercise including aerobic running with an intensity of 60 to 70% of maximum heart rate will be conducted. Resistance exercises are done using Bodybuilding machine with an intensity of 40 to 65% of 1RM. Intervention 2: Control group: Without intervention.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The study was not completed</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masomeh Amani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht Branch, Islamic Azad University, Taleshan Bridge</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>amanisetare@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ramin shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht Branch, Islamic Azad University, Taleshan Bridge</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>shabani_msn@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Girls with hypothyroid
Having age range 60 to 75 years
Not having exercise training</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with psychiatric and nervous disorders who are being treated with sedative medicines
Patients with orthopedic, verbal and auditory problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other hypothyroidism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Eight weeks of concurrent resistance and aerobic exercises with 3 sessions per week will be done. Aerobic exercise including aerobic running with an intensity of 60 to 70% of maximum heart rate will be conducted. Resistance exercises are done using Bodybuilding machine with an intensity of 40 to 65% of 1RM</i_keyword>
      <i_keyword>Control group: Without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TSH. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>T4. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Leptin. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Cortisol. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Fasting Blood glucose. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Cholstrol. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>HOMA. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using Insulin Resistance Formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rest Metabolism Rate. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using Mifflin formula.</sec_outcome>
      <sec_outcome>Anaerobic power. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: using RAST test.</sec_outcome>
      <sec_outcome>Aerobic power. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using shuttle run.</sec_outcome>
      <sec_outcome>Power. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using Force Gauges.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using by measurement of weight, body mass index (BMI), fat percent, fat free mass and waist circumference.</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>Rasht Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-17</approval_date>
        <contact_name>Ethics committee of Rasht Azad University</contact_name>
        <contact_address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-18</approval_date>
        <contact_name>Ethics committee of Rasht Azad University</contact_name>
        <contact_address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
