<?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>IRCT20220805055622N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-23</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>the effects of pranayama on the respiratory function in discharged covid-19 patients</public_title>
      <acronym></acronym>
      <scientific_title>the effects of pranayama on the respiratory function in discharged covid-19 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We divide people into individual blocks{7 blocks of 10} , which include the following variables.
Age-Sex-Education-Occupation-History of Disease-Body Mass Index {Method of measuring these 6 items is a questionnaire}
experimental group {measurement method is randomization}
6-min walk distance {chronometer}
Forced expiratory volume in 1-inspiratory capacity-inspiratory time to total breathing cycle time-Forced vital capacity-FEV1/FVC {measurement method is Spirometry}

Variable role: independent, dependent, contextual, and confounding
Variable type: continuous quantity, discrete quantity, rank quality, nominal quality
Measurement scale: nominal, ordinal, interval, relative.</study_design>
      <phase>N/A</phase>
      <hc_freetext>covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group :The intervention group should perform pranayama breathing 3 times a week for 6 weeks and the effect of this exercise will be measured using spirometry and 6 minutes walk .Exercises are provided to people in the form of brochures and educational videos. The executive protocol is as follows: First, sit on all fours on the floor in a comfortable position, so that the back is straight and not hunched over. The position of the eyes can be half open or closed. Breathing begins and all the focus and awareness of the person is directed to his breathing. Correct breathing method: inhale for 4 seconds, hold for 2 seconds and exhale for 4 seconds. According to the ability of each person, the duration of inhaling and exhaling should increase and the duration of inhaling should be longer than inhaling [if possible and without any pressure]. 10-12 times of this breathing. Another exhalation. A deep breath is taken from both nostrils. The right nostril is closed with the thumb and the exhalation comes out from the left nostril. The thumb still remains on the right nostril. Now one breath is done through the left nostril. The breath is held and the little finger is placed on the left nostril and the thumb is removed and exhaled through the right nostril. This breathing period should be done 8 to 10 times according to the person's capacity. This breathing should be done 3 times a week for 6 weeks. In case of dizziness or headache, you should immediately stop the exercise and rest in a state like prostration .After 6 weeks, spirometry and 6 minute walk are performed again and the results are compared with the control group. Intervention 2: Control group:  At the beginning of the study, the control group performs spirometry and 6 minute walk at the same time as the intervention group. In the continuation of the study, this group does not perform any breathing exercises. At the end of the study, after 6 weeks, this group is again performs spirometry and 6 minute walk and the result is measured with the intervention group.</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 A decision will be made after completing the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzie Shahriary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Modares Blv Modares Complex, Block 22, Floor 3, Unit 4</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7158715335</zip>
        <telephone>+98 71 3743 3525</telephone>
        <email>Marzieshahriary1@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzie Shahriary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Modares boulevard, modares complex, block22 ,floor3 ,unit4</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7158715335</zip>
        <telephone>+98 71 3743 3525</telephone>
        <email>marzieshahriary1@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient has been discharged from the hospital for a week.
over 18 years of age
In the past 6 months, he has not suffered from any other acute illness except for Covid-19.
The patient does not have Chronic obstructive pulmonary disease  or other respiratory diseases.
The participant's forced expiratory volume in 1s must be above 70%. (The recovered patient does not have severe respiratory restriction and is able to participate in the study)
The patient has been discharged from the hospital for a week</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have underlying cardiovascular diseases including severe ischemia or hemorrhagic stroke
Suffer from neurodegenerative diseases
Get infected with Covid-19 again and show symptoms of the disease</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group :The intervention group should perform pranayama breathing 3 times a week for 6 weeks and the effect of this exercise will be measured using spirometry and 6 minutes walk .Exercises are provided to people in the form of brochures and educational videos. The executive protocol is as follows: First, sit on all fours on the floor in a comfortable position, so that the back is straight and not hunched over. The position of the eyes can be half open or closed. Breathing begins and all the focus and awareness of the person is directed to his breathing. Correct breathing method: inhale for 4 seconds, hold for 2 seconds and exhale for 4 seconds. According to the ability of each person, the duration of inhaling and exhaling should increase and the duration of inhaling should be longer than inhaling [if possible and without any pressure]. 10-12 times of this breathing. Another exhalation. A deep breath is taken from both nostrils. The right nostril is closed with the thumb and the exhalation comes out from the left nostril. The thumb still remains on the right nostril. Now one breath is done through the left nostril. The breath is held and the little finger is placed on the left nostril and the thumb is removed and exhaled through the right nostril. This breathing period should be done 8 to 10 times according to the person's capacity. This breathing should be done 3 times a week for 6 weeks. In case of dizziness or headache, you should immediately stop the exercise and rest in a state like prostration .After 6 weeks, spirometry and 6 minute walk are performed again and the results are compared with the control group.</i_keyword>
      <i_keyword>Control group:  At the beginning of the study, the control group performs spirometry and 6 minute walk at the same time as the intervention group. In the continuation of the study, this group does not perform any breathing exercises. At the end of the study, after 6 weeks, this group is again performs spirometry and 6 minute walk and the result is measured with the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of respiratory volume. Timepoint: 6 week. Method of measurement: Spirometry.</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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-31</approval_date>
        <contact_name>Ethics committee of fasa university of medical sciences</contact_name>
        <contact_address>Ebn sina blv.fasa university of medical science Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
