<?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>IRCT20220611055133N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-29</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of chest expansion exercises on arterial blood oxygen saturation in patients with covid19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of chest expansion exercises on arterial blood oxygen saturation in hospitalized patients with covid 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64073</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study population :All patients confirmed with covid -19 by PCR test referring to BoAli Hospital in zahedan, Randomization description: The non-probability sampling method is easy (available)
The random allocation of patients to two groups is done by the permutation block stratified randomization method.In such a way that first the eligible referring patients are classified according to age and gender in the order of entry.Then based on blocks of 4(consisting of two groups A and B and two repetitions for each) which are randomly selected from all the possible states of permutations are selected and assigned to the desired group.These blocks were created using statistical software R version 4.0.2 , Blinding description: In the research , a one_way blind method is used so that the technician recording the results will not be aware of the desired intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Oxygen saturation level of arterial blood. Condition 2: Severity of chest pain. Condition 3: Severity of headache.</hc_freetext>
      <i_freetext>Intervention 1: Control group:Routine exercises(diaphragmatic breathing-pursed-Lip breathing)In the group of routine exercises,diaphragmatic breathing and pursed-lip breathing will be taught to the patient from the first day of the exercises.The patients are asked to do the exercises for 7 days and 3 sessions every day (morning-noon-evening)and each exercises 10 times.Then the results are once before the start of the exercises,once in the fourth session and once after the end of the 7 sessions,the treatment will be recorded in the eighth session. Intervention 2: Intervention group:chest expansion exercises.In the group of chest expansion exercises ,the first,second and third exercises will be taught to the patient on the first day of the exercises.Also,the patient will be taught the fourth exercise on the second day and the fifth exercise on the third day.The patients are asked to do the exercises for 7 days and 3 sessions every day (morning-noon-evening) and each exercises 10 times.Then the results are once before the start of the exercises,once in the fourth session and once after the end of the 7 sessions.The treatment will be recorded in the eighth session.</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>Ahmad Reza Askari Ashtiany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor Hesabi Square, Faculty of Rehabilitation, Zahedan University of Medical Sciences</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3329 5836</telephone>
        <email>ahmadaskary@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Reza Askari Ashtiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor Hesabi Squre, Faculty of Rehabilitation, Zahedan University of Medical Sciences</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3329 5836</telephone>
        <email>ahmadaskary@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with definite diagnosis of covid-19 by PCR test
Blood oxygen saturation level 75-93 % by pulse oximeter
Age 25 -55 years
Pulmonary involvement with corona pattern in lung CT SCAN or Chest X-ray
Patients who have at least two lobes of the lungs affected by the coronavirus
Patients under oxygen therapy
Patients treated with remdesivir and dexamethasone
Patients hospitalized in Boali Zahedan hospital
Patients for whom the infectious disease doctor has asked for respiratory physiotherapy consultation
Patients who are able to understand and perform breathing exercises
Patients who voluntarily consent to participate in the study</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients hospitalized in Icu who need intubation
A mild form of the disease that does not require hospitalization
Severely  ill patients who are intubated
Pregnancy
Patients with a history of cardiac arrhythmias and other respiratory diseases that have lung involvement
Tachycardia patients whose breathing exercises increase their heart Rate
Patients who have not completed traetment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>covid-19,virus identified</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group:Routine exercises(diaphragmatic breathing-pursed-Lip breathing)In the group of routine exercises,diaphragmatic breathing and pursed-lip breathing will be taught to the patient from the first day of the exercises.The patients are asked to do the exercises for 7 days and 3 sessions every day (morning-noon-evening)and each exercises 10 times.Then the results are once before the start of the exercises,once in the fourth session and once after the end of the 7 sessions,the treatment will be recorded in the eighth session.</i_keyword>
      <i_keyword>Intervention group:chest expansion exercises.In the group of chest expansion exercises ,the first,second and third exercises will be taught to the patient on the first day of the exercises.Also,the patient will be taught the fourth exercise on the second day and the fifth exercise on the third day.The patients are asked to do the exercises for 7 days and 3 sessions every day (morning-noon-evening) and each exercises 10 times.Then the results are once before the start of the exercises,once in the fourth session and once after the end of the 7 sessions.The treatment will be recorded in the eighth session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen saturation level of arterial blood. Timepoint: It will be measured and recorded once before the start of the exercises,once in the fourth session and once after the end of the seven sessions, i.e. in the eighth session. Method of measurement: Pulse oximeter device.</prim_outcome>
      <prim_outcome>Severity of chest pain. Timepoint: It will be measured and recorded once before the start of the exercises,once in the fourth session and once after the end of the seven sessions, i.e. in the eighth session. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Severity of headache. Timepoint: It will be measured and recorded once before the start of the exercises ,once in the fourth session and once after the end of the seven sessions, i.e. in the eighth session. Method of measurement: Visual Analogue Scale.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-17</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr.Hesabi Square - Medical Sciences Campus Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
