<?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>IRCT2016041727444N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-04</date_registration>
      <primary_sponsor>Vice Chanellor for research of Yasuj University of Medical Sciences</primary_sponsor>
      <public_title>Impact of movement on patient's physiological indices</public_title>
      <acronym></acronym>
      <scientific_title>The effect of passive movement of lower extremity on hemodynamic and ventilation parameters in patients under ventilator in intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22469</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The patients as research units will select from study population who will eligible according inclusion criteria using convenience sampling, then assignee to intervention group and control group by block random allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>patients under mechanical ventilation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Applying protocol of passive movement of lower extremity consist of raising each legs, up and down and rotational movements at the ankles, flexion and extension of  each knees and hip joints in addition to receiving  routine treatment and usual care. Intervention 2: Control group:giving routine treatment and usual care, but not giving research interventions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Zoladl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and midwifery, Shahid Dr.Jalil Street</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3323 5144</telephone>
        <email>zoladl.mohammad@yums.ac.ir</email>
        <affiliation>Yasuj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahla Najafi Dolatabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faulty of nursing and midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3323 5144</telephone>
        <email>shahlaiss@yahoo.com</email>
        <affiliation>Yasuj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: lack of deep vein thrombosis of lower extremities; lack of active rheumatoid arthritis; lack of fracture  or amputation of lower limbs; absence of congenital anomalies in lower extremities; lack of congestive heart failure; Lack of spine injury; completion of written informed consent by legal guardian; and exclusion criteria will :Lack of legal guardian’s motivation for continue the cooperation; exacerbation of patient’s condition that continuation of intervention won’t possible; patient’s transfer to another Hospital; incidence of dangerous dysrhythmia; incidence of symptoms of intracranial pressure increase; death of patient</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z51.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Medical care, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Applying protocol of passive movement of lower extremity consist of raising each legs, up and down and rotational movements at the ankles, flexion and extension of  each knees and hip joints in addition to receiving  routine treatment and usual care</i_keyword>
      <i_keyword>Control group:giving routine treatment and usual care, but not giving research interventions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran.</prim_outcome>
      <prim_outcome>Mean arterial blood pressure. Timepoint: At the beBefore intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after interventionginning of study. Method of measurement: According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran and insert amounts in formula: [(Systolic blood pressure+2 Diastolic blood pressure)/3].</prim_outcome>
      <prim_outcome>O2 saturation. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to percentage using Saadat vital sign monitoring equipment (saadat S740) made in iran.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to number per minute using Saadat vital sign monitoring equipment (saadat S740) made in iran.</prim_outcome>
      <prim_outcome>Pulse pressure. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran and insert amounts in formula: (Systolic blood pressure- Diastolic blood pressure).</prim_outcome>
      <prim_outcome>Temperature. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to centigrade using Saadat vital sign monitoring equipment (saadat S740) made in iran.</prim_outcome>
      <prim_outcome>Respiration rate. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to number per minute using Drager ventilator model Evita2 made in Germany.</prim_outcome>
      <prim_outcome>Respiratory tidal volume. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to ml using Drager ventilator model Evita2 made in Germany.</prim_outcome>
      <prim_outcome>Respiratory minute volume. Timepoint: Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day  after intervention. Method of measurement: According to ml using Drager ventilator model Evita2 made in Germany.</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>Vice Chanellor for research of Yasuj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-18</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, Yasuj University of Medical Science, Shahid Motahari Blvd. Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
