<?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>IRCT20221011056149N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-11</date_registration>
      <primary_sponsor>Iran National science foundation</primary_sponsor>
      <public_title>The effects of performing mental exertion during submaximal exercise</public_title>
      <acronym></acronym>
      <scientific_title>The effects of performing mental exertion during submaximal exercise with different intensities on brain metabolism and cognitive function in overweight individuals: fNIRS study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66289</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and obese.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: submaximal activity with moderate intensity (60% of the maximum wattage achieved in the previous two sessions) for 20 minutes, which is concurrent with mental effort (which is performed with the Stroop test), during which the Fnirs hat It is placed on the subject's head. It should be noted that before and after this test, a 10-minute flanker test is performed, during which the Fnirs cap measures brain metabolism.Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes. Intervention 2: The second intervention group: Submaximal activity with moderate intensity (60% of the maximum watts achieved in the previous two sessions) is performed for 20 minutes, during which the Fnirs hat is on the subject's head. It should be noted that before and After this test, a 10-minute flanker test is performed, during which the Fnirs hat measures brain metabolism. Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes. Intervention 3: The third intervention group: low-intensity submaximal activity (30% of the maximum wattage achieved in the previous two sessions) for 20 minutes, which is concurrent with mental effort (performed with the Stroop test), during which the Fnirs hat It is placed on the subject's head. It should be noted that before and after this test, a 10-minute flanker test is performed, during which the Fnirs cap measures brain metabolism. Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes. Intervention 4: The fourth intervention group: Submaximal activity with moderate intensity (60% of the maximum wattage achieved in the previous two sessions) is performed for 20 minutes, during which time the Fnirs hat is on the subject's head. It should be mentioned before and After this test, a 10-minute flanker test is performed, during which the Fnirs hat measures brain metabolism. Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Pourmirzaei Kouhbanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University., Shahid Shahriari Square, Evin., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 936 241 6182</telephone>
        <email>Samira_Pormirzaei@yahoo.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Pourmirzaei Kouhbanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Northeast side of Shahid Beheshti University.,Dazheh Blvd.,Shahid Shahriari Square (University).,Yemen Street., Chamran highway., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 34 3271 7520</telephone>
        <email>s.pourmirzaei@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 45 years
Overweight and obese people
being right-handed</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who have physical, mental and brain diseases.
People who take medicine.
People who have had regular sports activities in the past year.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: submaximal activity with moderate intensity (60% of the maximum wattage achieved in the previous two sessions) for 20 minutes, which is concurrent with mental effort (which is performed with the Stroop test), during which the Fnirs hat It is placed on the subject's head. It should be noted that before and after this test, a 10-minute flanker test is performed, during which the Fnirs cap measures brain metabolism.Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes.</i_keyword>
      <i_keyword>The second intervention group: Submaximal activity with moderate intensity (60% of the maximum watts achieved in the previous two sessions) is performed for 20 minutes, during which the Fnirs hat is on the subject's head. It should be noted that before and After this test, a 10-minute flanker test is performed, during which the Fnirs hat measures brain metabolism. Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes.</i_keyword>
      <i_keyword>The third intervention group: low-intensity submaximal activity (30% of the maximum wattage achieved in the previous two sessions) for 20 minutes, which is concurrent with mental effort (performed with the Stroop test), during which the Fnirs hat It is placed on the subject's head. It should be noted that before and after this test, a 10-minute flanker test is performed, during which the Fnirs cap measures brain metabolism. Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes.</i_keyword>
      <i_keyword>The fourth intervention group: Submaximal activity with moderate intensity (60% of the maximum wattage achieved in the previous two sessions) is performed for 20 minutes, during which time the Fnirs hat is on the subject's head. It should be mentioned before and After this test, a 10-minute flanker test is performed, during which the Fnirs hat measures brain metabolism. Also, the heart rate is recorded during the test with a polar heart rate monitor. The total test time is about 50 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxyhemoglobin. Timepoint: Before, during and after submaximal exercise. Method of measurement: Functional near-infrared spectroscopy, Rating of perceived exertion, Heart rate monitoring.</prim_outcome>
      <prim_outcome>Deoxyhemoglobin. Timepoint: Before, during and after submaximal exercise. Method of measurement: Functional near-infrared spectroscopy, Rating of perceived exertion, Heart rate monitoring.</prim_outcome>
      <prim_outcome>Total hemoglobin. Timepoint: Before, during and after submaximal exercise. Method of measurement: Functional near-infrared spectroscopy, Rating of perceived exertion, Heart rate monitoring.</prim_outcome>
      <prim_outcome>Maximum oxygen consumption. Timepoint: During a graded exercise test. Method of measurement: Respiratory gas analysis device, Rating of perceived exertion, Heart rate monitoring.</prim_outcome>
      <prim_outcome>Maximum fat oxidation. Timepoint: During a graded exercise test. Method of measurement: Respiratory gas analysis device, Rating of perceived exertion, Heart rate monitoring.</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>صندوق حمایت از پژوهشگران و فناوران کشور</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-19</approval_date>
        <contact_name>Ethics Committee in Biological Research of Shahid Beheshti University</contact_name>
        <contact_address>Shahid Beheshti University., Shahid Shahriari Square., Evin., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
