<?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>IRCT20210830052343N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise on sleep habits of children with asthma</public_title>
      <acronym></acronym>
      <scientific_title>The effect of scheduled exercises on sleep habits of children with asthma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58594</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, based on the inclusion criteria, available sampling will be done and then the list of sample people will be given to SPSS software and using random block sequence generation software, half of the sample will be allocated to the intervention group and the other half to the control group.
Concealment of random allocation will be done by the method of opaque sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, the scheduled exercises will be taught to children and parents by the researcher in the physiotherapy department of Akbar Children's Hospital. After the training session, these children will perform the exercises in three sleeping, sitting and standing positions in a safe space at home for eight weeks and six sessions per week (3 sessions of physical exercises and 3 sessions of breathing exercises- periodically). One physical training session will include 3 parts of warm-up movements (10-15 minutes), selected core exercises (30-35 minutes) and cooling exercises (about 10 minutes). Breathing exercises will include normal breathing, bud lip breathing, and diaphragmatic breathing. Each session will gradually increase the number and timing of physical exercises and breathing exercises. Intervention 2: Control group: Children in the control group will receive routine care during this period and will engage in normal and daily physical activities. They will also receive an educational pamphlet on routine care for a child with asthma.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Parnian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Dormitory, Dormitory Affairs Office, Mashhad University of Medical Sciences Campus, Shahid Saremi Blvd., Piroozi Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948988</zip>
        <telephone>+98 71 5345 3019</telephone>
        <email>Parnians992@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Monir Ramezani Farmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, University St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>RamezaniMN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire of the child and her/his parents to participate in the research
The age of the child is from 6 years to 15 years
Registration of mild to moderate persistent asthma according to the doctor (at least 3 months ago)
According to the doctor's diagnosis, the child's asthma is well controlled
Permission from the treating physician to participate in the research</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Attendance of the child in physiotherapy, occupational therapy and rehabilitation programs
Have a history of regular exercise in the last 6 months
Having a specific mental illness
Having epilepsy
Have a history of heart and thyroid disease
Existence of movement problems or joint disorders
Use of sleeping pills and tobacco
Having known congenital disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>X (J45)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the respiratory system (Asthma)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, the scheduled exercises will be taught to children and parents by the researcher in the physiotherapy department of Akbar Children's Hospital. After the training session, these children will perform the exercises in three sleeping, sitting and standing positions in a safe space at home for eight weeks and six sessions per week (3 sessions of physical exercises and 3 sessions of breathing exercises- periodically). One physical training session will include 3 parts of warm-up movements (10-15 minutes), selected core exercises (30-35 minutes) and cooling exercises (about 10 minutes). Breathing exercises will include normal breathing, bud lip breathing, and diaphragmatic breathing. Each session will gradually increase the number and timing of physical exercises and breathing exercises.</i_keyword>
      <i_keyword>Control group: Children in the control group will receive routine care during this period and will engage in normal and daily physical activities. They will also receive an educational pamphlet on routine care for a child with asthma.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Habits Score in Children's Sleep Habits Questionnaire. Timepoint: Sleep habits will be measured in 3 times. 1. Before the intervention 2. During the intervention (4 weeks after the start of the intervention) 3. After the intervention. Method of measurement: Children's Sleep Habits Questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-14</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>the central building of Mashhad University of Medical Sciences, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
