<?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>IRCT20200326046861N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-02</date_registration>
      <primary_sponsor>University of Esfahan</primary_sponsor>
      <public_title>Comparison of resistance and concurrent training on physiological variables of intellectually disabled children</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of resistance and concurrent training on physiological variables of intellectually disabled children with overweight</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46778</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 22 Intellectual disabillies children with overweight who were in our study area were divided into two equal groups of 12 peopel using a simple random sampling wethod(resistance training group and combined exercise group). the random sampling was such that the subjects were first ranked based on their body was index. In the second step is based on ABBA method. First, the person with the highest body mass index was in group A; the second and third person with the highest body mass index was in group B, and the fourth person( fourth rank) was in group A, and continued until the last one to be equal in accordance with the ABBA method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>of intellectually disabled children with overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: A 12-member group of resistance training protocol includes seven movements (step-by-step exercise, step-by-step exercise, squatting, long and sitting exercise, bridge on the ground, forearm dumbbell, dumbbell behind the arm) and up to 12 weeks And 3 days and This was done for 1 hour a week. Intervention 2: Intervention Group 2: A 12-person combined exercise protocol group was also performed for 12 weeks and 3 days per week for 1 hour. In the aerobic exercise section, the heart rate was adjusted to 50 to 80 percent of its maximum heart rate. Endurance training included brisk walking or running, and resistance training included strengthening the biceps, triceps, abdominal muscles of the back thigh muscles, and the front thigh muscles.</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 Because my information is personal</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh mardanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi square,Hezarjarib</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8195633361</zip>
        <telephone>009837934244</telephone>
        <email>farzaneh72mn@gmail.com</email>
        <affiliation>University of Esfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Vazgen Minasyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi square, Hezar jarib</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8195633361</zip>
        <telephone>+98 31 3793 4244</telephone>
        <email>v.minasian@spr.ui.ac.ir</email>
        <affiliation>University of Esfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Trainable mentally retarded
No other disease(cardiovascular disease)</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Medical problems
drug use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Moderate intellectual disabilities</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: A 12-member group of resistance training protocol includes seven movements (step-by-step exercise, step-by-step exercise, squatting, long and sitting exercise, bridge on the ground, forearm dumbbell, dumbbell behind the arm) and up to 12 weeks And 3 days and This was done for 1 hour a week.</i_keyword>
      <i_keyword>Intervention Group 2: A 12-person combined exercise protocol group was also performed for 12 weeks and 3 days per week for 1 hour. In the aerobic exercise section, the heart rate was adjusted to 50 to 80 percent of its maximum heart rate. Endurance training included brisk walking or running, and resistance training included strengthening the biceps, triceps, abdominal muscles of the back thigh muscles, and the front thigh muscles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aerobic capacity. Timepoint: Before and 12 weeks after intervention. Method of measurement: 20 m sweep test.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Before and 12 weeks after intervention. Method of measurement: Y balance test.</prim_outcome>
      <prim_outcome>Body fat percentage. Timepoint: Before and 12 weeks after intervention. Method of measurement: Harbinger calipers.</prim_outcome>
      <prim_outcome>Abdominal muscles endurance. Timepoint: Before and 12 weeks after intervention. Method of measurement: The long test of the Eifford meeting for one minute.</prim_outcome>
      <prim_outcome>Flexibility. Timepoint: Before and 12 weeks after intervention. Method of measurement: Sit and brush test.</prim_outcome>
      <prim_outcome>Trunk Power. Timepoint: Before and 12 weeks after intervention. Method of measurement: Korea-made handheld and multifunction manometers with the mark SEHAN.</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>Dr. Rasoul Roknizadeh</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-04</approval_date>
        <contact_name>Ethics Committee of University of Isfahan</contact_name>
        <contact_address>Azadi Square, Hezar Jarib Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
