<?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>IRCT20221112056480N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-29</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise training on the quality and quantity of sleep in children with diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of sports training on the quality and quantity of sleep in children aged 6 to 12 years with type 1 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66864</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study included two experimental and control groups. The intervention for the experimental group consisted of 8 weeks of regular exercise program. There is no intervention for the control group. The group will carry out its usual routine, Randomization description: Samples are calculated using G*power sample size calculation software. Considering the effect size of 0.871, alpha value of 0.05, and test power of 0.90, 62 people are included in the study. The samples will be randomly divided into two control and intervention groups (blocks with a size of four). Random allocation software is used for randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 1 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention includes the implementation of sports exercises based on sports instructions. The video of these exercises will be sent to parents using virtual social networks (Eta, Rubika, Shad). The exercise training protocol (warming up, brisk walking, and cooling down) consists of eight weeks of training. There are 3 training sessions per week and each session includes 30 minutes of training. After the intervention, the sleep habits questionnaire will be completed by the parents. Intervention 2: Control group: This group will have daily and routine walks.</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>Kimia Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 3330 0661</telephone>
        <email>pr@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kimia Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 3330 0661</telephone>
        <email>pr@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children who are in the age range of 6 to 12 years.
Children who have a history of diabetes for one year.
Children whose parents live in Kermanshah.
Children who do not have a specific mental or cognitive illness.
Children who do not have musculoskeletal diseases.
Children who have not participated in another diabetes education program in the past month.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who have concurrent diseases such as kidney diseases
Children who use drugs that affect blood sugar, such as Corticosteroids
Children who are resistant to autoimmune diseases affecting insulin.
Children who are active in a particular sport</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention includes the implementation of sports exercises based on sports instructions. The video of these exercises will be sent to parents using virtual social networks (Eta, Rubika, Shad). The exercise training protocol (warming up, brisk walking, and cooling down) consists of eight weeks of training. There are 3 training sessions per week and each session includes 30 minutes of training. After the intervention, the sleep habits questionnaire will be completed by the parents.</i_keyword>
      <i_keyword>Control group: This group will have daily and routine walks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Habits Score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Bedtime Resistance score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Sleep Onset Delay score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Sleep Duration score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Sleep Anxiety score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Night Wakings score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Parasomnias score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Sleep Disordered Breathing score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</prim_outcome>
      <prim_outcome>Daytime Sleepiness score. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Children’s Sleep Habits Questionnaire (CSHQ).</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-19</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
