<?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>IRCT20200411047029N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-07</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pulmonary rehabilitation Mobile base application</public_title>
      <acronym></acronym>
      <scientific_title>The effect of pulmonary rehabilitation Mobile based application on quality of life, depression and Anxiety and activity daily living in patients Recovered of with Covid 19 undergoing pulmonary rehabilitation referred to the comprehensive respiratory clinic of Khorshid Hospital in 1400</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62193</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to divide patients into two groups, they will be given mini-mapping software. Mini-magnification (or mini-magnifier) ​​is the name of a software that is used to divide samples into groups in clinical trials. There are always variables in research projects that may affect the accuracy of the study (confounding variables); By entering these variables in this software, the variables are distributed among the research groups in such a way that there is the least difference between the groups, and therefore this method is preferable to the randomization method. Sampling process until the number Research units will continue to reach the desired number.</study_design>
      <phase>N/A</phase>
      <hc_freetext>covid 19.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group (mobile-based pulmonary rehabilitation software) after completing the questionnaires as a pre-test, a briefing session will be held by a specialist nurse on how to work with the software for them and then the educational content of how Patient care will be installed in the same content as the face-to-face training group in the form of software that can be installed on the Android operating system on patients' mobile phones or tablets. This software consists of different parts, the first part includes the management of software users, where it is possible to insert and edit patient information from the management and the possibility of entering personal information through the software.The second part includes educational content. The educational content in the software is similar to the face-to-face training group. The third part includes sending notifications to all users and the last part is the possibility of talking to the patient and caregiver with an online counselor. An online counselor in this plan is someone who is available to patients around the clock, who in the software discussion section, any questions and ambiguities about working with the program or educational content, any emergency or non-emergency counseling related to The condition of patients and ... responds. Intervention 2: Control group: The control group in the face-to-face training session of patients, educational content according to the needs of patients in groups of 5 people in 12 sessions that will last twice a week and each session will last 1 to 3 hours.</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 It is necessary to make the necessary checks first and we will publish if possible</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ramin Sami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>r.sami@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Sami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 913 322 1022</telephone>
        <email>r.sami@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Declare willingness to participate in the study by completing the informed consent form
Age category 18-60 years
Internet access and mobile phone to use mobile-based lung rehabilitation software
Have a minimum literacy
No vision or hearing problems
Have the literacy to use a mobile phone to work with mobile-based lung rehabilitation software
At least 21 days have elapsed since the onset of symptoms in patients with severe coronary artery disease.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to participate in the study
Participate in similar courses simultaneously
Definitive evidence of venous and pulmonary thromboembolism
Acute symptoms of Covid 19 (temperature over 38 degrees ....)
Systolic blood pressure less than 90 mm Hg, diastolic blood pressure less than 60 mm Hg
Systolic blood pressure above 140 mm Hg and diastole above 90 mm Hg
History of heart disease class 4-2
Ischemic or hemorrhagic stroke or neurodegenerative diseases
Major mental disorder according to psychiatrist (schizophrenia, paranoid disorders and major depression)
Any disorder that restricts the patient's ability to move during pulmonary rehabilitation
Patients with active cancer
Patients receiving palliative care
Absence of more than 2 sessions in pulmonary rehabilitation training programs or failure to answer the researcher's call more than 2 times a week</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>In the intervention group (mobile-based pulmonary rehabilitation software) after completing the questionnaires as a pre-test, a briefing session will be held by a specialist nurse on how to work with the software for them and then the educational content of how Patient care will be installed in the same content as the face-to-face training group in the form of software that can be installed on the Android operating system on patients' mobile phones or tablets. This software consists of different parts, the first part includes the management of software users, where it is possible to insert and edit patient information from the management and the possibility of entering personal information through the software.The second part includes educational content. The educational content in the software is similar to the face-to-face training group. The third part includes sending notifications to all users and the last part is the possibility of talking to the patient and caregiver with an online counselor. An online counselor in this plan is someone who is available to patients around the clock, who in the software discussion section, any questions and ambiguities about working with the program or educational content, any emergency or non-emergency counseling related to The condition of patients and ... responds.</i_keyword>
      <i_keyword>Control group: The control group in the face-to-face training session of patients, educational content according to the needs of patients in groups of 5 people in 12 sessions that will last twice a week and each session will last 1 to 3 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: 6 months. Method of measurement: SF-12 Quality of Life Questionnaire, HADS Hospital Anxiety and Depression Scale, Bartel Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress and depression. Timepoint: 6 months. Method of measurement: Anxiety and Depression Clinical Scale Questionnaire(HADS).</sec_outcome>
      <sec_outcome>Fasting days of life. Timepoint: 6 months. Method of measurement: Bartel Questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-22</approval_date>
        <contact_name>Ethics committee of isfahan University of Medical Sciences</contact_name>
        <contact_address>hezarjarib isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
