<?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>IRCT20220103053616N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-09</date_registration>
      <primary_sponsor>Hakim Sabzevari University</primary_sponsor>
      <public_title>The Effect of selected exercise training on physical fitness indices and social interaction in childeren with autism spectrum disorders.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of selected exercise training on physical fitness indices and social interaction in childeren with autism spectrum disorders.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61053</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation software was used for randomization tools and to hide allocation concealment from opaque envelopes sealed with random sequence.
In this method, each of the random sequences created was recorded on a card and the cards were placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes were numbered in the same way on the outer surface. Finally, the letter envelopes were glued and placed in a box, respectively. Eligible participants, one of the envelopes was opened in order, and the group assigned to that participant was revealed, Blinding description: Outcome assessors and data analysts did not know which individual belonged to the control group or the experimental group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>AUTISM spectrum disorders.</hc_freetext>
      <i_freetext>Intervention group: The experimental group participated in a selective exercise program consisting of hand-held play, rhythmic movements by rhythmic song and resistance training with stretching for 8 weeks (3 sessions per week)..</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:
Only part of the data, such as information about the main outcome, and its results are shared

When:
Access started from 2021

To whom:
Researchers working in academic and scientific institutions

Conditions:
To carry out research projects

Where to obtain:
sending email

How to obtain:
Send email and the purpose and reason for the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>shokofeh broughani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 15, Eram19, Eram ST, Sabzevar</address>
        <city>sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9618665737</zip>
        <telephone>+98 51 4467 5281</telephone>
        <email>shokofeh.broughani@yahoo.com</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>shokofeh broughani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 15, Eram19,Eram ST, sabzevar</address>
        <city>sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9618665737</zip>
        <telephone>+98 51 4467 5281</telephone>
        <email>shokofeh.broughani@yahoo.com</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with autism
Age 5 to 10 years
Clinical examination by a specialist doctor for physical activity
No history of cardiorespiratory disease
Written consent of the child's parent or legal guardian
No severe movement limitations</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to perform the exercise
Absence from regular training sessions (3 consecutive sessions and 5 non-consecutive sessions)
Injury
Illness and any other obvious disorder other than autism that can be considered as the main diagnosis.
personal reasons</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experimental group participated in a selective exercise program consisting of hand-held play, rhythmic movements by rhythmic song and resistance training with stretching for 8 weeks (3 sessions per week).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social interaction. Timepoint: At the beginning of the study (before the intervention) and eight weeks after the start of the exercise program. Method of measurement: Gilliam Autism Test (GARZ).</prim_outcome>
      <prim_outcome>Physical fitness Indices ( Anthropometric tests, cardiopulmonary endurance, leg and trunk explosive power, hand muscle strength, flexibility, static balance, agility, hand grip strength, coordination). Timepoint: At the beginning of the study (before the intervention) and eight weeks after the start of the exercise program. Method of measurement: For anthropometric evaluation, height and weight were measured by meters and scales. Body mass index was calculated by dividing weight (kg) by height squared (m2). Evaluation of cardiorespiratory fitness (20-meter shuttle run  test), explosive power (sergeant  test), trunk explosive power (medical ball throwing test), static balance (strok test), agility (T test),  hand grip strength (hand dynamometer), flexibility (Wells test) and coordination of the Nelson selective response motor test were used.</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>Hakim Sabzevari University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-12</approval_date>
        <contact_name>Ethics Committee in Biomedical Research OF Hakim Sabzevari University</contact_name>
        <contact_address>Hakim Sabzevari University,Tohid Shahr,Sabzevar,Khorasan Razavi SABZEVAR Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
