<?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>IRCT20200506047324N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Swimming Training and Omega-3 Intake on Irisin and Body Composition in Obese Girls with Down Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Swimming Training and Omega-3 Intake on Irisin and Body Composition in Obese Girls with Down Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47973</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simplified Accidentalization Method Simple Accidental Methods Used Individual Accidental Hidden Sequence Sequence The use of opaque envelopes for division into two groups was a randomization tool using Rand Between software that divided individuals into two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Down Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Swimming training, 8 weeks of swimming exercises, 3 sessions per week and an average of 60 minutes of swimming activity per session, which includes 10 minutes of warming up, 45 minutes of breast crawl swimming and five minutes of cooling. Warming up includes stretching exercises. It was out of the water and walking and warming up in the water. Cooling also includes playing in the water. Intervention 2: Intervention group: Swimming Training + Omega 3 Supplements 3. Get pre-workout supplements that have received 300 mg of Omega 3 capsules for 8 weeks and three times a week. Omega-3 capsules were purchased from the Ministry of Health's pharmaceutical company Alhawi.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ElhamAlsadat Zeinali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 37,West Kavian Alley,Jolfa Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1541749415</zip>
        <telephone>+98 21 2284 3502</telephone>
        <email>ases.zeinali@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahin Riyahi Malayeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Afsariyeh Three Ways - Imam Reza Highway - 18 km - Ghiamdasht City - End of Shahid Bahonar St. - Islamic Azad University, East Tehran Branch - Physical Education and Sports Sciences Department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1866113118</zip>
        <telephone>+98 21 3359 4950</telephone>
        <email>shahinriyahi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Girls with Down Syndrome, 3 to 15 years old, in the pool of Shahid Rezaei Brothers,Region 5 Tehran
Public health approval based on a special questionnaire and general practitioner's approval
In addition to daily activities, they have their own swimming exercises</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with epilepsy
any physiological or metabolic abnormalities
physical problems and obvious genetic abnormalities
And there are several disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Down syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Swimming training, 8 weeks of swimming exercises, 3 sessions per week and an average of 60 minutes of swimming activity per session, which includes 10 minutes of warming up, 45 minutes of breast crawl swimming and five minutes of cooling. Warming up includes stretching exercises. It was out of the water and walking and warming up in the water. Cooling also includes playing in the water</i_keyword>
      <i_keyword>Intervention group: Swimming Training + Omega 3 Supplements 3. Get pre-workout supplements that have received 300 mg of Omega 3 capsules for 8 weeks and three times a week. Omega-3 capsules were purchased from the Ministry of Health's pharmaceutical company Alhawi.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Irisin. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: ELISA method using ELISA Kit irisin kit with a picogram sensitivity of milliliters.</prim_outcome>
      <prim_outcome>Body weight. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: INBODY device.</prim_outcome>
      <prim_outcome>Fat percentage. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: INBODY device.</prim_outcome>
      <prim_outcome>Muscle percentage. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: INBODY device.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: Laboratory method.</prim_outcome>
      <prim_outcome>Tri glyceride. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: Laboratory method.</prim_outcome>
      <prim_outcome>Low Density Lipoprotein. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: Laboratory method.</prim_outcome>
      <prim_outcome>High Density Lipoprotein. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: Laboratory method.</prim_outcome>
      <prim_outcome>Height. Timepoint: Measure before using Omega 3 and training and after eight weeks of intervention. Method of measurement: centimeter.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-01</approval_date>
        <contact_name>Ethics committee of Islamic Azad of Tehran University of Medical Sciences</contact_name>
        <contact_address>Shariati St. - Khaghani St. - Islamic Azad University of Medical Sciences, Tehran - School of Medicine Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
