<?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>IRCT20220723055525N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-07</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of pulmonary rehabilitation on the prognosis of patients with Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of pulmonary rehabilitation in the rehabilitation center in comparison with tele rehabilitation on the prognosis of patients with Covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64952</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization tool is version 2 of the Random Allocation software. 
Using the software, the order of the random chain is determined, and then the patients of the intervention and control groups are entered into the chain based on the order obtained through the software. 
For example, first blocks of 8 are prepared, each block of 8 includes 4 patients for the control group and 4 patients for the intervention group. In one block, the first four patients may be placed in the control group and the next four patients in the intervention group, and in another block, the patients may be divided one by one.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Corona disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the first group are treated with a course of respiratory muscle physiotherapy by visiting the rehabilitation center. These measures are performed on the day of the patient's visit and then repeated 1 month and 3 months later in 15-minute sessions. In this treatment method, strengthening of respiratory muscles is taught by performing movements. Equipment or medicine is not used during these sessions. Intervention 2: Control group: The patients of the second group are treated with a 15-minute respiratory physiotherapy program, which is taught how to do it by a brochure, and they are followed up on the day of referral, and then 1 month later and 3 months later in terms of home training. In this treatment method, strengthening of respiratory muscles is taught by performing movements. No equipment or medicine is used in this method.</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>soheila shahbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam reza hospital, Etemad zade Ave., Fatemi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1854614117</zip>
        <telephone>+98 21 8609 6350</telephone>
        <email>so.sh82@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam reza hospital, Etemad zade Ave., Fatemi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1854614117</zip>
        <telephone>+98 21 8609 6350</telephone>
        <email>so.sh82@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with difinit diagnosis of COVID-19 according to PCR
Age between 30 to 60 years
Having symptoms of cough and dyspnea
Moderate to severe pulmonary involvement according to CT scan ( less than 50%  pulmonary involvement according to CT scan)
3 weeks after positive PCR test
No COPD disease
No cardiac disease</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>COPD, asthma and any underlying lung disease
Neuromuscular diseases that affect lung function
History of ischemic heart disease, congestive heart failure and uncontrolled blood pressure
Asymptomatic carriers
Severe comorbidity
Unwillingness to participate in the study
Lack of access to the Internet and virtual programs</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the first group are treated with a course of respiratory muscle physiotherapy by visiting the rehabilitation center. These measures are performed on the day of the patient's visit and then repeated 1 month and 3 months later in 15-minute sessions. In this treatment method, strengthening of respiratory muscles is taught by performing movements. Equipment or medicine is not used during these sessions.</i_keyword>
      <i_keyword>Control group: The patients of the second group are treated with a 15-minute respiratory physiotherapy program, which is taught how to do it by a brochure, and they are followed up on the day of referral, and then 1 month later and 3 months later in terms of home training. In this treatment method, strengthening of respiratory muscles is taught by performing movements. No equipment or medicine is used in this method.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. Method of measurement: Quality of life questionnaire.</prim_outcome>
      <prim_outcome>Activities of daily living. Timepoint: Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. Method of measurement: Daily activity questionnaire.</prim_outcome>
      <prim_outcome>Psychological status in terms of anxiety and depression. Timepoint: Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. Method of measurement: Hospital anxiety and depression scale.</prim_outcome>
      <prim_outcome>Barthel index. Timepoint: Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. Method of measurement: Barthel questionnaire.</prim_outcome>
      <prim_outcome>6 minute walking test. Timepoint: Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. Method of measurement: 6 minute walking test results.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulse rate. Timepoint: Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. Method of measurement: Pulse oximeter device.</sec_outcome>
      <sec_outcome>Oxygen saturation percentage. Timepoint: Before starting pulmonary rehabilitation and then 1 month and 3 months after rehabilitation. Method of measurement: Pulse oximeter device.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-22</approval_date>
        <contact_name>Ethics committee of Artesh University of Medical Sciences</contact_name>
        <contact_address>Imam Reza hospital, Etemad zade Ave, Fatemi Street, Amirabad tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
