<?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>IRCT20190129042547N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-04</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of physical rehabilitation program’s implementation on the physical performance and quality of life on Children undergoing cardiac surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of physical rehabilitation program’s implementation on the physical performance and quality of life rate on hospitalized children undergoing congenital heart disease surgery in intensive care units of chamran hospital in 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38296</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The research area of the pediatric intensive care unit of Martyr Dr. Chamran Hospital, Randomization description: Random assignment is used in two groups of random numbers.Using this table, by closing the eyes and by placing a finger on one of the numbers, that number will be selected.The direction to move is predefined and horizontally to the right, then to the top and then to the left of the table.Each number will be placed in group A or intervention, and each pair number will be entered in group B or control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>congenital heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Use of three rehab techniques after the presence of a child in the intensive care unit following cardiac surgery: 1-   Kinesitherapy(KTH) 2-Respiratory Physical Therapy 3-Sitting Balance Exercise:This part of the movements, day-after-surgery moves will begin with a balanced baby's condition, which will be held once a day, at least three times a day, and each time it lasts for 20 to 60 minutes.----Program designed for home activity:Postural training-Flexibility training-Breathing training-Muscle strength training-Developmental activities-Aerobic endurance training:These movements will be started in a month and on a daily basis from the time the child is admitted to the pediatric ward and will continue at home.Each session of the program includes 5 to 10 minutes of warm-up, 30 minutes of aerobic exercise, with a low to moderate intensity and 5 minutes of cooling down. Intervention 2: Control group: For the control group, the routine of the child care and care units and the protocol that the hospital has implemented so far will be used, including providing family descriptions of physical rehab programs in verbal conversation and answering their questions in this regard And offering educational pamphlets.For the investigated families, a classroom session is organized individually and grouply, at the beginning of the course.</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 After the study is completed, its impact on the target group will be published if necessary</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khalifezadeh Asghar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4,40 Alley,Dashtestan Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461- 81746</zip>
        <telephone>+98 31 3792 7511</telephone>
        <email>khalifezadeh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khalifehzadeh Asghar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No4,4o Alley ,Dashtestan Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461- 81746</zip>
        <telephone>+98 313115677097</telephone>
        <email>khalifezadeh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- The research unit has no psychiatric disorders or limiting movements
- have age limits of between three years of age
- The doctor will allow the child to attend the rehab program
- Not accompanied by congenital anomaly of the heart with other physical disorders
- Failure to implement previous rehab programs on the research unit
Research units or parents who would like to participate in this research project
- His vital signs are within his normal range
- During the procedure, only the parents will take care of the child before surgery until one month later
- Their place of residence is Isfahan city and the area where the researcher is able to meet their personal presence.
- Ability to make phone calls and stay in touch with the family
Children aged 3 to 7 years with congenital heart defects</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Child's death during study
- Family unwillingness to continue active participation in the research
The presence of threatening arrhythmias
- Failure in renal function or other organs of the body
Failure of the physician to continue the rehab program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congenital malformation of heart, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Use of three rehab techniques after the presence of a child in the intensive care unit following cardiac surgery: 1-   Kinesitherapy(KTH) 2-Respiratory Physical Therapy 3-Sitting Balance Exercise:This part of the movements, day-after-surgery moves will begin with a balanced baby's condition, which will be held once a day, at least three times a day, and each time it lasts for 20 to 60 minutes.----Program designed for home activity:Postural training-Flexibility training-Breathing training-Muscle strength training-Developmental activities-Aerobic endurance training:These movements will be started in a month and on a daily basis from the time the child is admitted to the pediatric ward and will continue at home.Each session of the program includes 5 to 10 minutes of warm-up, 30 minutes of aerobic exercise, with a low to moderate intensity and 5 minutes of cooling down.</i_keyword>
      <i_keyword>Control group: For the control group, the routine of the child care and care units and the protocol that the hospital has implemented so far will be used, including providing family descriptions of physical rehab programs in verbal conversation and answering their questions in this regard And offering educational pamphlets.For the investigated families, a classroom session is organized individually and grouply, at the beginning of the course.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical performance. Timepoint: Before the intervention and one month after the discharge from the hospital. Method of measurement: Early Years Physical Activity Questionaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention and one month after the discharge from the hospital. Method of measurement: Paediatric Quality of Life Inventory.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-27</approval_date>
        <contact_name>Vice- chancellor in research affairs -medical univercity of isfahan</contact_name>
        <contact_address>Deputy of Research and Technology of the University,Building No. 4,Isfahan University Of Medical Sciences,Heza jerib Ave isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
