<?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>IRCT20230407057840N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-06</date_registration>
      <primary_sponsor>University of Guilan</primary_sponsor>
      <public_title>Comparison of the effect and durability of a course of Exercise Program and sport Game on Motor Competence and Physical Performance of Adolescents with Intellectual Impairment</public_title>
      <acronym>ID / II</acronym>
      <scientific_title>Comparison of the effect and durability of a course of Exercise Program and sport Game on Actual Motor Competence and Physical Performance of Adolescents with Intellectual Impairment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69704</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The present research, after the implementation of 8 weeks of intervention (sports exercises and sports games), in order to evaluate the sustainability of the interventions, after 3 months, the dependent variables will be evaluated again, Randomization description: In this research, the subjects were selected in an accessible and purposeful way and according to the desired criteria and by simple randomization, using a random numbers table, and Online randomization and using Numbered containers with a random sequence in groups Intervention (exercises and sports games) and control will be divided, Blinding description: People with Intellectual Impairment will be divided according to the simple randomization method (intervention or Control groups). The randomization method is done by one of the researchers and the clinical caregivers, evaluators, participants and data analyzer are blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People with intellectual impairment (intellectual disabilities).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 8-week course (three sessions per week) of exercise with a combination of aerobic and resistance exercises designed for people with intellectual impairment (modeling from similar studies and considering the abilities of people with intellectual impairment) will perform. Intervention 2: Intervention group: 8-week course (three sessions per week) of sports games with a combination of football and basketball, based on similar studies and according to the abilities of people with intellectual impairment, as well as interest and available facilities, will be designed and implemented. Intervention 3: Control group: During the period of receiving the protocols by the intervention groups, they continue their normal life and refrain from participating in any regular sports activities.</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 a part of the data, such as the information related to the main outcome or the like, can be shared after the completion of the project.

When:
The access period starts 9 months after the publication of the results and articles.

To whom:
The data will be available to researchers.

Conditions:
The detailed information of the study can be provided to competent researchers interested in the field of intellectual impairment.

Where to obtain:
Contact by email: miladfadaei71@gmail.com

How to obtain:
Competent and interested researchers can receive data documentation after publication of the work from the corresponding author by providing their academic information and identification.

Comments:
This clinical trial with the title "Comparison of the effect and durability of a course of Exercise Program and sport Game on Actual Motor Competence and Physical Performance of Adolescents with Intellectual Impairment" has not been previously registered anywhere else and has not been sent anywhere else at the same time. We are very happy to register our clinical trial with IRCT. Thank you. Wishing you health and happy moments.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Milad Fadaei Dehcheshmeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P. 96, Laleh second st, Laleh town</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515933156</zip>
        <telephone>+98 24 3377 8942</telephone>
        <email>miladfadaei71@gmail.com</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Milad Fadaei Dehcheshmeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P. 96, Laleh second st, Laleh town</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515933156</zip>
        <telephone>+98 24 3377 8942</telephone>
        <email>miladfadaei71@gmail.com</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Intellectual Disability (Intellectual Impairment)
Being in the group of educable Intellectual Disability (IQ 50-75)
The ability to participate in exercise sessions regularly (maximum absence of three sessions during the exercise period)
Being in the age range between 7 and 14 years
Ability to implement exercise programs
The satisfaction of the subjects, their families and their guardians for cooperation in the research</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not being excessive overweight or obese
No history of doing sports and exercises for at least 1 year
Avoiding exercises or intense activities during the research
Absence of severe structural abnormalities
Participation in rehabilitation and occupational therapy courses that have an effect on the exercise program
Taking special drugs that affect motor and cognitive function</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>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 8-week course (three sessions per week) of exercise with a combination of aerobic and resistance exercises designed for people with intellectual impairment (modeling from similar studies and considering the abilities of people with intellectual impairment) will perform.</i_keyword>
      <i_keyword>Intervention group: 8-week course (three sessions per week) of sports games with a combination of football and basketball, based on similar studies and according to the abilities of people with intellectual impairment, as well as interest and available facilities, will be designed and implemented.</i_keyword>
      <i_keyword>Control group: During the period of receiving the protocols by the intervention groups, they continue their normal life and refrain from participating in any regular sports activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Actual motor competence that expresses fundamental motor skills. Timepoint: Measurements in the pre-test and before the implementation of the protocol, post-test and after the implementation of the protocol and after 3 months of the implementation of the protocol. Method of measurement: Using test of gross motor development Ulrich version-2.</prim_outcome>
      <prim_outcome>Physical performance that includes gait and functional and static balances. Timepoint: Measurements in the pre-test and before the implementation of the protocol, post-test and after the implementation of the protocol and after 3 months of the implementation of the protocol. Method of measurement: gait using Kinovea software, functional balance using the timed up &amp; go test (TUG) and static balance using the standing stork test.</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>University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-19</approval_date>
        <contact_name>Research Ethics Committees of Sport Sciences Research Institute (SSRI)</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
