<?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>IRCT20180503039517N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>High-intensity interval training and sleep regulation on glucose homeostasis and growth hormone in girls with sleep disorders</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of High-Intensity Interval Training, Sleep Regulation and Combination on Glucose Homeostasis, Growth Hormone, Cortisol, and Lactate Levels, Sleep Quality, Aerobic Power and Reaction Time in Adolescent Girls with Sleep Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60307</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 80 females with sleep disorders will be selected by the available sampling method. Through a lottery (participants' names were written on paper and will be divided into 4 groups (3 intervention and 1 control groups) through random lottery), Blinding description: In this research, responsible for collecting and processing the data, the type of intervention, and the participants in the research groups are unaware.</study_design>
      <phase>3</phase>
      <hc_freetext>Sleep disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: high intensity interval training. High intensity interval training group will perform four weeks, three sessions a week, 3 sets of RAST protocol with 3 minutes rest between each set in the first week, to which one set will be added every week and finally in the fourth week will reach six sets. Each set consisted of 6*35-meter sprints with a 10-second break between each repetition. Training sessions will be conducted at morning. Polar heart rate monitor is used to control the intensity of training. Intervention 2: Intervention group: sleep regulation. Each participant will be given an individualized sleep schedule that sets the time for going to bed, turning off the lights, and waking up for each day. The average time spent going to bed, turning off the lights, and waking up each person reported in her bedroom will be used to calculate these. Intervention 3: Intervention group 3: combined. The combined group will perform both high intensity interval training and sleep regulation interventions. Intervention 4: Control group: Participants in this group will not receive any intervention and will continue their daily routine as usual.</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>Soleyman Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan Blv</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41476-54919</zip>
        <telephone>+98 13 3342 4073</telephone>
        <email>solomonansari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soleyman Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan Blv</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41476-54919</zip>
        <telephone>+98 13 3342 4073</telephone>
        <email>solomonansari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having sleep disorders using the Pittsburgh Questionnaire scales
Regular menstrual cycle
No special diet</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>17 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of sleeping drugs
History of mental illness and hormonal disorders
Two frequent or 3 consecutive sessions of absence in the training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: high intensity interval training. High intensity interval training group will perform four weeks, three sessions a week, 3 sets of RAST protocol with 3 minutes rest between each set in the first week, to which one set will be added every week and finally in the fourth week will reach six sets. Each set consisted of 6*35-meter sprints with a 10-second break between each repetition. Training sessions will be conducted at morning. Polar heart rate monitor is used to control the intensity of training.</i_keyword>
      <i_keyword>Intervention group: sleep regulation. Each participant will be given an individualized sleep schedule that sets the time for going to bed, turning off the lights, and waking up for each day. The average time spent going to bed, turning off the lights, and waking up each person reported in her bedroom will be used to calculate these.</i_keyword>
      <i_keyword>Intervention group 3: combined. The combined group will perform both high intensity interval training and sleep regulation interventions.</i_keyword>
      <i_keyword>Control group: Participants in this group will not receive any intervention and will continue their daily routine as usual.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glucose homeostasis. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: the evaluation method of homeostasis model (HOMA-IR) and measuring insulin and glucose (enzyme calorimetric kit of Pars-Azmoun company), fasting was estimated according to the following formula:[ HOMA-IR = insulin (MU × lit) × glucose (nmol / lit) ÷ 22/5].</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Aerobic power. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Aerobic power in this study will be measured by a shuttle run test.</sec_outcome>
      <sec_outcome>Reaction speed. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: A two-way general visual reaction time test will be used to measure the dynamic reaction time of the whole body.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Pittsburgh Questionnaire.</sec_outcome>
      <sec_outcome>Growth hormone. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Dbc Canadiangoose Elisa kit.</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>2021-09-19</approval_date>
        <contact_name>research ethics committees of islamic azad university-Rasht Branch</contact_name>
        <contact_address>Lakan Blv Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
