<?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>IRCT20200706048032N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-22</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>Physical activity in children with attention deficit hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effect of physical activity with and without cognitive  demand  on the improvement of executive function and behavioral symptoms in children with  ADHD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50243</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In the intervention, motor activities are performed with cognitive exercises, Randomization description: The limited block randomization method will be used for randomization, so that in order to determine the experimental and control groups, 15 balls with code A will be considered for the experimental group and 15 balls with code B for the control group. They will then be placed inside the lottery container and, without replacement, the balls will be randomly removed from the container and the sequence created will be recorded. Next, based on the research sample size, a number of aluminum envelopes are prepared and each random sequence is recorded on a card. The cards are placed in the envelopes in order. To maintain the random sequence, the envelopes are numbered in the same way on their outer surface. Finally, the flaps of envelopes will be glued and then they are placed in a box in order. At the beginning of the participants’ registration, according to the entry order of participants qualified for including in the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: In this study, participants after obtaining informed consent and being randomly placed in the experimental and control groups, will not receive any information about how the other group is intervened, as well as how they themselves are positioned as the experimental group or the control group; and also the evaluators of individual results will be selected from outside the study team. In this case, the researcher's own knowledge of the type of intervention assigned to the study participants can not affect the data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention Deficit Hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:: In this group, the intervention is presented in the form of purposeful motor activities that require cognitive tasks. The tools required for the intervention is the cognitive rehabilitation software based on Excir (Nejati) movement, which tries to rehabilitate and strengthen cognitive functions by purposefully increasing the cognitive needs of the movement. For this purpose, considering the principles governing cognitive rehabilitation and movement, motor tasks have been designed that progressively involve various cognitive functions. In this program, in addition to cognitive rehabilitation software, several color banners are used on which different numbers and directions and different colors are designed, and the participants move on the banners according to the cognitive tasks provided in the software. Participants will do these tasks twice a week for one hour. Intervention 2: Control group:: In this group, aerobic activities such as running, which do not require cognitive tasks, are presented. Participants will perform these movements twice a week for one hour in a safe environment.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit209,Floor2,Velenjak St,Daneshjoo Blvd,Shahid Beheshti University,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2240 7609</telephone>
        <email>nejati@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid  Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit209,Floor2,Velenjak St,Daneshjoo Blvd,Shahid Beheshti University,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2240 7601</telephone>
        <email>nejati@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of attention deficit hyperactivity disorder by a psychiatrist
Placement between the ages of 7 and 12.
Having informed consent to participate in research</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other comorbid disorders such as learning disability, conduct disorder, etc.
Having borderline IQ.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, combined type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:: In this group, the intervention is presented in the form of purposeful motor activities that require cognitive tasks. The tools required for the intervention is the cognitive rehabilitation software based on Excir (Nejati) movement, which tries to rehabilitate and strengthen cognitive functions by purposefully increasing the cognitive needs of the movement. For this purpose, considering the principles governing cognitive rehabilitation and movement, motor tasks have been designed that progressively involve various cognitive functions. In this program, in addition to cognitive rehabilitation software, several color banners are used on which different numbers and directions and different colors are designed, and the participants move on the banners according to the cognitive tasks provided in the software. Participants will do these tasks twice a week for one hour.</i_keyword>
      <i_keyword>Control group:: In this group, aerobic activities such as running, which do not require cognitive tasks, are presented. Participants will perform these movements twice a week for one hour in a safe environment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral symptoms. Timepoint: At the beginning of the study (before the intervention) and 45, 75 days after the intervention. Method of measurement: Conners Behavioral Symptoms Scale for Parents and Teachers.</prim_outcome>
      <prim_outcome>Working memory. Timepoint: At the beginning of the study (before the intervention) and 45, 75 days after the intervention. Method of measurement: Neurological test (N-back).</prim_outcome>
      <prim_outcome>Inhibit response. Timepoint: At the beginning of the study (before the intervention) and 45, 75 days after the intervention. Method of measurement: Neurological test (go-no go).</prim_outcome>
      <prim_outcome>Cognitive flexibility. Timepoint: At the beginning of the study (before the intervention) and 45, 75 days after the intervention. Method of measurement: Neurological test (Wisconsin).</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>Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-25</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Medical Sciences</contact_name>
        <contact_address>Islamic Azad University of Medical Sciences, Tehran Branch,KHaghani St,Shariyati St,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
