<?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>IRCT20211119053107N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-09</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effect of passive walking exercises on the cardiac and respiratory system of patients admitted to intensive care units</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of passive walking -like Exercise on cardiac and respiratory parameters of patients admitted to intensive care units: Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60073</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The first step of creating a random sequence: In this study, the limited randomization method of block randomization will be used. In this two-group experiment, we will have four blocks consisting of two participants in the intervention group and two participants in the control group.
There will be six different modes in these four blocks; So we prepare six cards as follows:

3. PMPM 2. PMMP 1. PPMM
4. MPMP 6. MPPM 5. MMPP
  
Given that the number of patients studied is estimated at 50, we remove 13 of the above cards by replacement.

The second step of hiding accident allocation: The selection of cards will be determined using a table of random numbers in Software Allocation Random. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. Then, based on the obtained blocks and allocation sequence, they will be divided into intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Respiratory failure. Condition 2: Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, in addition to routine care, it will perform passive walking exercises. The passive walking method is repeated 5 times a week for 2 weeks and 20 minutes of practice each time. Walking involves moving the hip, knee and ankle joints. Due to the unavailability of the device and the high cost of providing the device, the simulated walking of the protocol is performed as follows: Step 1: Flexion-extension of the right thigh with a maximum range of 45 degrees at a speed of 30 times per minute , Runs for 10 minutes; Second stage: Flexion-extension of the left thigh is practiced similarly to the right thigh; Runs 30 times per minute for 10 minutes; Step 4: According to the third step, flexion-knee extension and dorsi-plantar flexion of the left ankle are practiced; The researcher goes to the intensive care unit and on the patient's bed, performs this procedure for 2 weeks (5 sessions per week) while the patient is lying down and about 30 degrees above the head. Intervention 2: Control group: do not receive intervention, receive routine care.</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>Yosra Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery; Dolatabad; Isar Square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714673159</zip>
        <telephone>+98 83 3816 2532</telephone>
        <email>yosrakarimi@ymail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery; Dolatabad; Isar Square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714673159</zip>
        <telephone>+98 83 3816 2532</telephone>
        <email>A_abdi61@yahoo.com</email>
        <affiliation>Kermanshah 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>
    </countries>
    <criteria>
      <inclusion_criteria>At least 18 years old
Connecting to a mechanical ventilation that is at least 24 hours old
Hemodynamic and cardiac stability
Confirmation of the treating physician that the patient is not prohibited from performing the protocol
Obtaining written consent from the patient's legal guardian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Increasing of intracranial pressure
Having a history of previous or rapidly growing neuromuscular disease
Spinal cord injury
Cardiopulmonary arrest
Having fractures in the pelvis and lower limbs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J96.9</hc_code>
      <hc_code>I50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory failure, unspecified</hc_keyword>
      <hc_keyword>Heart failure, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the intervention group, in addition to routine care, it will perform passive walking exercises. The passive walking method is repeated 5 times a week for 2 weeks and 20 minutes of practice each time. Walking involves moving the hip, knee and ankle joints. Due to the unavailability of the device and the high cost of providing the device, the simulated walking of the protocol is performed as follows: Step 1: Flexion-extension of the right thigh with a maximum range of 45 degrees at a speed of 30 times per minute , Runs for 10 minutes; Second stage: Flexion-extension of the left thigh is practiced similarly to the right thigh; Runs 30 times per minute for 10 minutes; Step 4: According to the third step, flexion-knee extension and dorsi-plantar flexion of the left ankle are practiced; The researcher goes to the intensive care unit and on the patient's bed, performs this procedure for 2 weeks (5 sessions per week) while the patient is lying down and about 30 degrees above the head.</i_keyword>
      <i_keyword>Control group: do not receive intervention, receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average shock index. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Shock Index=(Heart Rate)/(Systolic Blood Pressure)- Physiological indicators(Cardiorespiratory monitoring).</prim_outcome>
      <prim_outcome>Average of mean arterial pressure. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Mean arterial pressure = (systole + 2 diastole) / 3 _ Physiological indicators(pressure indicator).</prim_outcome>
      <prim_outcome>Average airway resistance. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Airway resistance= tail end wedge pressure - alveolar_ ventilator pressure_ ventilator.</prim_outcome>
      <prim_outcome>Average compliance. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Compliance = volume change / pressure change_ ventilator.</prim_outcome>
      <prim_outcome>Average relative arterial oxygen pressure to percentage of tail oxygen. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: PaO2 / FiO2=Relative arterial oxygen pressure / percentage of tail oxygen - a tool for measuring _Physiological indicators(Cardiorespiratory monitoring).</prim_outcome>
      <prim_outcome>Average peak inspiratory pressure. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: ventilator.</prim_outcome>
      <prim_outcome>Average systolic and diastolic blood pressure. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Physiological indicators(pressure indicator).</prim_outcome>
      <prim_outcome>Average heart rate. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Physiological indicators(Cardiorespiratory monitoring).</prim_outcome>
      <prim_outcome>Average respiration rate. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Physiological indicators(Cardiorespiratory monitoring).</prim_outcome>
      <prim_outcome>Average percentage of peripheral blood oxygen saturation. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Physiological indicators(Cardiorespiratory monitoring).</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-14</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology; Building No. 2 of Medical Sciences; Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
