<?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>IRCT20240502061629N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-08</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>the effect of two methods of routine breathing exercises and the simultaneous use of routine breathing and breathing-stretching exercises in patients with chronic obstructive pulmonary disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two methods of routine breathing exercises (pursed lip breathing and diaphragmatic breathing) and the simultaneous use of routine breathing and breathing-stretching exercises on respiratory indicators (oxygen saturation percentage and carbon dioxide pressure), disease severity and exercise capacity in patients with chronic obstructive pulmonary disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76608</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: At first, by using the available sampling method, inpatients with entry criteria are identified and based on the Global Initiative for Chronic Obstructive Lung Disease criteria, grade 2 and 3 chronic obstructive pulmonary disease patients are selected.  In the next step, random allocation is done using a table of random numbers and patients are divided into two control groups (breathing exercises) and intervention (simultaneous use of breathing and breathing-stretching exercises), Blinding description: After the necessary information regarding conducting the research is provided to the patients, written informed consent is obtained from the patients;  And after random allocation, patients are divided into two control groups (breathing exercises) and intervention (simultaneous use of breathing and breathing-stretching exercises). Participants will be informed of their presence in the intervention or control group only after the intervention is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: chronic obstructive pulmonary disease. Condition 2: chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: this group receives breathing-stretching exercises, in addition to routine breathing exercises (pursed lip and diaphragmatic breathing). Stretching exercises with breathing control will be performed for the intervention group for 5 days and twice a day (at 10 am and 6 pm).  Stretching exercises are done by controlling deep breathing exercises, inhaling through the nose and exhaling through the mouth.  The stretching time will be with the inhaling and the tension releasing time will be with the exhaling. On the first day, the patient stretches his hands, wrists and ankles with breathing control while lying on the bed.  On the second day, he repeats the exercises of the first session while sitting on the bed and with his legs extended.  On the third day, while sitting on the bed, he performs the exercises of the first day along with neck stretching exercises.  On the fourth day, the patient gets out of bed and walks and performs arm and shoulder stretching exercises while walking.  On the fifth day, the patient tries to walk by raising the knee as much as possible and repeats the stretches of the fourth day. Intervention 2: Control group: The control group only receives routine breathing exercises (pursed lip and diaphragmatic breathing).</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 data is potentially shareable after  individuals become incognito.

When:
The beginning of the access period is 6 months after the results are published.

To whom:
The data will be available for students, professors and researchers working in academic and scientific institutions.

Conditions:
Sending a request through the researcher's email is to access data or documents.  The use of data is subject to strict compliance with literary rights and confidentiality.

Where to obtain:
Send a request through the following email to receive data/documents.
 fateme.zare@jums.ac.ir
 Fatemeh Zareh, nursing master of science student

How to obtain:
After the request for data/document via the researcher's email, your email will be answered within 7 days at most.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Sadr Shirazi St., Forsat Shirazi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7157664667</zip>
        <telephone>+98 71 3722 7476</telephone>
        <email>fateme.zare@jums.ac.ir</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Sadr Shirazi St., Forsat Shirazi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7157664667</zip>
        <telephone>+98 71 3722 7476</telephone>
        <email>fateme.zare@jums.ac.ir</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient will to participate in the study
Not suffering from a known mental disorder (such as psychotic and depressive disorders that do not cooperate)
Absence of acute and chronic diseases affecting the respiratory system (such as colds and flu)
The ability to talk in Persian
Not suffering from other chronic diseases that interfere with the rehabilitation program (such as skeletal-motor disorders)
patients with stage 2 and 3 of the disease based on  Global Initiative for Chronic Obstructive Lung Disease classification
Obtaining lung fellowship approval</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-cooperation or unwillingness of the patient to continue participating in the study
Occurrence of any complication or exacerbation of the disease (patients whose disease worsens due to causes such as pneumonia, pneumothorax or heart failure or patients who need to be hospitalized) that requires intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J43</hc_code>
      <hc_code>J44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Emphysema</hc_keyword>
      <hc_keyword>Other chronic obstructive pulmonary disease</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 receives breathing-stretching exercises, in addition to routine breathing exercises (pursed lip and diaphragmatic breathing). Stretching exercises with breathing control will be performed for the intervention group for 5 days and twice a day (at 10 am and 6 pm).  Stretching exercises are done by controlling deep breathing exercises, inhaling through the nose and exhaling through the mouth.  The stretching time will be with the inhaling and the tension releasing time will be with the exhaling. On the first day, the patient stretches his hands, wrists and ankles with breathing control while lying on the bed.  On the second day, he repeats the exercises of the first session while sitting on the bed and with his legs extended.  On the third day, while sitting on the bed, he performs the exercises of the first day along with neck stretching exercises.  On the fourth day, the patient gets out of bed and walks and performs arm and shoulder stretching exercises while walking.  On the fifth day, the patient tries to walk by raising the knee as much as possible and repeats the stretches of the fourth day.</i_keyword>
      <i_keyword>Control group: The control group only receives routine breathing exercises (pursed lip and diaphragmatic breathing).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen saturation percentage. Timepoint: before the start of the intervention and 5 days after the start of the intervention. Method of measurement: Pulse oximetr.</prim_outcome>
      <prim_outcome>Carbon dioxide pressure. Timepoint: before the start of the intervention and 5 days after the start of the intervention. Method of measurement: Venous blood gases.</prim_outcome>
      <prim_outcome>The score that people will get from the chronic obstructive pulmonary disease assessment test. Timepoint: before the start of the intervention and 5 days after the start of the intervention. Method of measurement: chronic obstructive pulmonary disease assessment test.</prim_outcome>
      <prim_outcome>The distance that people travel in 6 minutes. Timepoint: before the start of the intervention and 5 days after the start of the intervention. Method of measurement: 6-Minute walk test.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-29</approval_date>
        <contact_name>Ethics Committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Jahrom University of Medical Sciences, after Nursing College, Ostad Motahari Street, Jahrom Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
