<?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>IRCT20200512047407N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-23</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>The effect of 8 weeks of aerobic exercise under hypoxia and normoxia on plasma irisin levels and insulin resistance in men with metabolic syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of aerobic exercise under hypoxia and normoxia on plasma irisin levels and insulin resistance in men with metabolic syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48047</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity and overweight.</hc_freetext>
      <i_freetext>Intervention group: In the hypoxia group, a hypoxia tent was used to create hypoxia conditions. It had a tent, a compressor to dilute the oxygen concentration, a sensor to determine the oxygen concentration according to the required height, a pulse oximeter device to monitor the blood oxygen level, a time adjustment system program to perform the exercise program according to the desired time. The hypoxia group performed their training according to the training protocol defined for research in oxygen concentration equal to 15% and with a height of 2700 meters inside the tent. In all stages of training, training schedule, training intensity, heart rate and pedaling frequency of the subjects were monitored and recorded in seconds by the monitoring system connected to the Monarch bicycle. The aerobic training group performed this exercise with the same intensity and protocol in space..</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 I have not yet made a decision to publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>peyman mohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah, Zan Boulevard, Ab Street</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>323548545</zip>
        <telephone>+98 83 3425 2887</telephone>
        <email>payman_mohammadi@ymail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>peyman mohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah, Zan Boulevard, Ab Street</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3235841654</zip>
        <telephone>+98 83 3425 2887</telephone>
        <email>payman_mohammadi@ymail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Lack of specific cardiovascular, respiratory and kidney diseases
3- No history of mountaineering in 6 months before the start date of the research</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Sports activity in the last 6 months
Use of special medication during the last 6 months
History of participating in continuous mountaineering activities</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the hypoxia group, a hypoxia tent was used to create hypoxia conditions. It had a tent, a compressor to dilute the oxygen concentration, a sensor to determine the oxygen concentration according to the required height, a pulse oximeter device to monitor the blood oxygen level, a time adjustment system program to perform the exercise program according to the desired time. The hypoxia group performed their training according to the training protocol defined for research in oxygen concentration equal to 15% and with a height of 2700 meters inside the tent. In all stages of training, training schedule, training intensity, heart rate and pedaling frequency of the subjects were monitored and recorded in seconds by the monitoring system connected to the Monarch bicycle. The aerobic training group performed this exercise with the same intensity and protocol in space.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Iris is a myocaine 112 amino acid that was recently discovered in 2012. Irisin is a hormone stimulated by exercise that is secreted by skeletal muscle in white mice and humans, and stimulates the conversion of white adipose tissue to quasi-brown adipose tissue, which is the conversion of systemic metabolism by increasing energy costs. Improves. Timepoint: Beginning and end of 8 weeks. Method of measurement: Start with 8 weeks using blood sampling and measuring kits.</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>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-26</approval_date>
        <contact_name>Medical Ethics Committee</contact_name>
        <contact_address>Kermanshah, Zan Boulevard, Ab Street kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
