<?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>IRCT20201204049600N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-06</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the impact of breathing exercises on general health of patient infected with Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact of breathing exercise ( through virtual education )on the general health of patients infected with Covid-19 in shiraz . Randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this clinical intervention study, patients in both groups are the same and are randomly assigned;  Thus, random allocation of patients is done using block randomization with two permutations AB and BA.  In this way, 35 numbers are randomly selected from the table of random numbers, and if the numbers are between zero and 4, block AB is assigned to them, and if they are 5-9, block BA is assigned to them, and thus two lists of 35 people include two  We will have an intervention and control group at random.  For concealment, this method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by this person who is unaware of the division of groups, Blinding description: Participant: In this study, we are not able to blind the patient, because patients of both interventions are aware of the type of intervention. 
Clinical caregiver: We teach the person in charge of patient care and follow-up how to complete the questionnaire. This person has no knowledge of the type of patient intervention. 
Researcher: In this study, we do not have the ability to blind the researcher, because the research does both studies himself and is aware of the type of intervention in each group.
 Outcome Assessor: Completed questionnaires are given to a person who is not aware of the interventions performed and he / she is asked to determine the amount of stress, anxiety and depression reduction and increase general health in each person according to the questionnaire.
 Data Analyzer: The questionnaires are finally given to a person to review the information after completing and collecting all the information. This person does not know any of the steps of the work and how to divide the intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group learns breathing exercises completely for a month through cyberspace (WhatsApp and Instagram).  Then we will contact them regularly (two to three times a week) and answer their questions.  Patients fill in the questionnaires at the beginning and end of the study.  Patients exercise for one month and six days a week, three times a day and five times a day. Intervention 2: Intervention group: This group only receives educational pamphlets and basic trainings at the beginning of the month.  But they are asked to do exercises 6 times a week, 3 times a day, 5 times a day.  The difference is that we do not have much contact with patients during a month and only at the beginning and end of the study, the questionnaires are filled out by patients.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All available data can be shared after making people unidentifiable

When:
Access period starts 1year after the results are published.

To whom:
everyone can access to this information

Conditions:
If the information in this study helps to improve the science process

Where to obtain:
Drsheidashojaei@gmail.com 00989214783046

How to obtain:
After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permited.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sheida Shojaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doostan apartment, Alley 24th, Narvan street, Eram blvd., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71447-54388</zip>
        <telephone>+98 71 4224 1345</telephone>
        <email>Drsheidashojaei@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sheida Shojaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doostan apartment, Next to the Bakery,24th Narvan Alley,Narvan street, Eram blvd, Shiraz.</address>
        <city>Shirazi</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۴۴۷-۵۴۳۸۸</zip>
        <telephone>+98 71 4224 1345</telephone>
        <email>Drsheidashojaei@gmail.com</email>
        <affiliation>Shiraz 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>
    </countries>
    <criteria>
      <inclusion_criteria>Being diagnosed with COVID-19 through PCR test.
Pulmonary involvement with typical pattern through Chest X-ray or Chest CT Scan.
A mild form of disease which enables patients to look after themselves at home and  they do not need to be hospitalized.
Having clinical stability.
Being able to understand and do breathing exercises online.
Being in the 18 to 65 age groups.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence and history of other lung diseases such as COPD and asthma...
History of advanced heart disease such as IHD and CHF...
History of uncontrolled diseases including liver, kidney and thyroid and...
History of hospitalization in ICU due to Corona VIRUS.
History of lower motor neuron diseases including motor neuron diseases, peripheral neuropathy, neuromuscular junction disease and myopathy
History of upper motor neuron diseases such as stroke and M.S  and... .
Lack of access and awareness of cyberspace.
Dissatisfaction with participating in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_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>Intervention group: This group learns breathing exercises completely for a month through cyberspace (WhatsApp and Instagram).  Then we will contact them regularly (two to three times a week) and answer their questions.  Patients fill in the questionnaires at the beginning and end of the study.  Patients exercise for one month and six days a week, three times a day and five times a day.</i_keyword>
      <i_keyword>Intervention group: This group only receives educational pamphlets and basic trainings at the beginning of the month.  But they are asked to do exercises 6 times a week, 3 times a day, 5 times a day.  The difference is that we do not have much contact with patients during a month and only at the beginning and end of the study, the questionnaires are filled out by patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduce general health of patient infected with Covid-19. Timepoint: The beginning and the end of the study. Method of measurement: General health qustionnair (GHQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function of patient. Timepoint: The beginning and the end of the study. Method of measurement: Medical Research Council Breathlessness Scale (MRC dyspnea scale).</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>Shiraz University of medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-14</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Doostan apartment, Alley 24th, Narvan street, Eram blvd., shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
