<?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>IRCT20220815055703N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-15</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of chest physiotherapy in the treatment of covid-19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of chest physiotherapy on the clinical outcomes of patients with COVID 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65321</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, we use the method of block randomization with blocks with size of 4 and for this purpose, we prepare four sheets of paper. On the two sheets we write the letter I meaning "Intervention" and on the other two sheets we write the letter C meaning "Control". Mix the sheets together and place them in the desk drawer. Upon referral to any of the eligible patients, one of the sheets will be randomly pulled out and based on this sheet being drawn I or C will be assigned to one of the two intervention or comparison groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigating the effect of chest physiotherapy on the recovery of patients with covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group will undergo chest physiotherapy in addition to routine care related to the care of patients with covid-19. Chest physiotherapy intervention will be done for six days and every morning and evening for 20 minutes. Physiotherapy of the chest will also be performed by the physiotherapist of the centers every morning and evening. At the end of the third and sixth days, the patients of both groups will be evaluated in terms of FEV1/FVC, FEV1, and FVC parameters using the clinical status survey form. Intervention 2: Control group: patients in the control group only receive routine care (depending on the severity of the disease and the underlying diseases of the patient, including oxygen therapy, required supportive treatments, preventive anticoagulation treatment, diagnostic tests, imaging procedures, emphasis on healthy eating and rest sufficient) related to the care of patients with covid-19 will receive. At the end of the third and sixth days, the patients of both groups will be evaluated in terms of FEV1/FVC, FEV1, and FVC parameters using the clinical status survey form.</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>Reza Moradi Azgil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17 Amar St</address>
        <city>Iezh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 4363 1059</telephone>
        <email>rezanurs73@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Moradi Azgil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17 Amar St</address>
        <city>Iezh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 4363 1059</telephone>
        <email>rezanurs73@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Desire to participate in the study
The average severity of the disease based on the diagnosis of a doctor specializing in respiratory diseases
Hospitalization at the time of diagnosis
Not using other chest physiotherapy programs at the same time
Absence of underlying diseases such as cancer, cardiovascular diseases and diabetes
Patient alertness
Able to perform chest physiotherapy activities</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance or refusal to participate in the study
Changing the level of severity of the disease from moderate to severe level of the disease
Having respiratory failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group will undergo chest physiotherapy in addition to routine care related to the care of patients with covid-19. Chest physiotherapy intervention will be done for six days and every morning and evening for 20 minutes. Physiotherapy of the chest will also be performed by the physiotherapist of the centers every morning and evening. At the end of the third and sixth days, the patients of both groups will be evaluated in terms of FEV1/FVC, FEV1, and FVC parameters using the clinical status survey form.</i_keyword>
      <i_keyword>Control group: patients in the control group only receive routine care (depending on the severity of the disease and the underlying diseases of the patient, including oxygen therapy, required supportive treatments, preventive anticoagulation treatment, diagnostic tests, imaging procedures, emphasis on healthy eating and rest sufficient) related to the care of patients with covid-19 will receive. At the end of the third and sixth days, the patients of both groups will be evaluated in terms of FEV1/FVC, FEV1, and FVC parameters using the clinical status survey form.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vital capacity (FEV2/FVC ratio). Timepoint: Before starting the intervention and at the end of the sixth day after the start of the intervention (physiotherapy). Method of measurement: Spirometry device.</prim_outcome>
      <prim_outcome>Arterial blood gases include: (PaO2), (PaCO2), (SaO2), (PaO2/FiO2). Timepoint: Before starting the intervention and at the end of the sixth day after the start of the intervention (physiotherapy). Method of measurement: Arterial blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vital capacity Vital capacity (FEV2/FVC ratio). Timepoint: At the end of the third and sixth days after the intervention (physiotherapy). Method of measurement: Spirometry device.</sec_outcome>
      <sec_outcome>Arterial blood gases include: (PaO2), (PaCO2), (SaO2), (PaO2/FiO2). Timepoint: At the end of the sixth day after the start of the intervention (physiotherapy). Method of measurement: Arterial blood test.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-30</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Boulevard of Medical Sciences, Ahvaz, Khuzestan Province Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
