<?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>IRCT20210717051910N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-30</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of the breathing exercises on quality of life and symptoms of shortness of breath and fatigue in patients with Covid 19</public_title>
      <acronym></acronym>
      <scientific_title>Effect of the breathing exercises on quality of life and symptoms of shortness of breath and fatigue in patients with Covid 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57538</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using simple randomization method using random table of numbers, subjects will be divided into two groups of intervention and control. Randomization units are one of the patients referred to the Corona ward. Randomization tool is also a random table of numbers. The researcher puts numbers on one of the random table numbers and moves to the right and bottom. Records the numbers and assigns them to different study groups whose numbers are already specified, Blinding description: The data collected from both groups will be provided to the data analyzer without specifying which control or esoterry groups were related.</study_design>
      <phase>N/A</phase>
      <hc_freetext>covid-19b.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During 6 weeks, after sending the video and training brochure of breathing exercises as well as checklists that show how to do breathing exercises which are explained in the checklist of breathing exercises and breathing in the form of bud lip 5 to 10 times each time, breathing The diaphragm is 5 to 15 times per session at home twice a day (morning and evening) for 42 days without interruption. It is sent to the intervention group after 2 weeks of discharge from the hospital, in addition to providing educational content to In the intervention group, telephone calls to patients are made by the researcher for 6 weeks. In this way, telephone calls are made twice a week in the first 4 weeks and once a week in the second 2 weeks with the intervention group. The time of the conversation is between 10-12 in the morning and the duration of each conversation is between 5-10 minutes and the content of the conversation will include self-introduction, questions about the patient's general health, and encouraging the patient to follow the recommendations made. Intervention 2: Control group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, SF-36 quality of life questionnaire, Borg shortness of breath scale and FSS fatigue severity scale) will be established and completed using a telephone call within 6 weeks.</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 Its release schedule is still unclear</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Golrokh Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Narmak Street Afshari Kahkvand Alley No. 4 Unit 8</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1645913539</zip>
        <telephone>+98 21 7784 2192</telephone>
        <email>Abdolahygolii@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Golrokh Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Narmak Street Afshari Alley Avansian No. 4 Unit 8</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1645913539</zip>
        <telephone>+98 21 7784 2192</telephone>
        <email>Abdolahygolii@gmail.com</email>
        <affiliation>Tehran 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>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with COVID-19 with respiratory symptoms with radiological manifestations as one or two-way multilobular infiltration in CT scan or chest x-ray whose disease has been confirmed by nasal swap test (RT-PCR SARS-CoV-2)
You have symptoms of shortness of breath or fatigue or every two weeks after discharge from the hospital.
Having a mobile phone
Ages 18 to 60</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hospitalized in ICU Covid-19
Patients with moderate to severe heart failure (grade III or IV, New York Heart Association)
Having COPD or other respiratory and infectious diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>covid19, virus not identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: During 6 weeks, after sending the video and training brochure of breathing exercises as well as checklists that show how to do breathing exercises which are explained in the checklist of breathing exercises and breathing in the form of bud lip 5 to 10 times each time, breathing The diaphragm is 5 to 15 times per session at home twice a day (morning and evening) for 42 days without interruption. It is sent to the intervention group after 2 weeks of discharge from the hospital, in addition to providing educational content to In the intervention group, telephone calls to patients are made by the researcher for 6 weeks. In this way, telephone calls are made twice a week in the first 4 weeks and once a week in the second 2 weeks with the intervention group. The time of the conversation is between 10-12 in the morning and the duration of each conversation is between 5-10 minutes and the content of the conversation will include self-introduction, questions about the patient's general health, and encouraging the patient to follow the recommendations made.</i_keyword>
      <i_keyword>Control group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, SF-36 quality of life questionnaire, Borg shortness of breath scale and FSS fatigue severity scale) will be established and completed using a telephone call within 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shortness of breath. Timepoint: Measurement of shortness of breath will be done before the intervention and 6 weeks after the intervention. Method of measurement: Borg Shortness of breath.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Fatigue will be measured before the intervention and 6 weeks after the intervention. Method of measurement: FSS Fatigue Intensity Scale.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Quality of life will be measured before the intervention and 6 weeks after the intervention. Method of measurement: Quality of Life Questionnaire SF-36.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-27</approval_date>
        <contact_name>Reserch Ethics Committees of school of nursing and midwifery &amp; rehabilitation-Tehran University of M</contact_name>
        <contact_address>School of Nursing and Midwifery, Nosrat St., Enghelab Square, Tehran University of Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
