<?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>IRCT20110509006416N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-22</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of breathing techniques on COPD</public_title>
      <acronym></acronym>
      <scientific_title>Effects of of breathing techniques on pulmonary function and quality of life in adults with chronic obstructive pulmonary diseases (COPD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The daily list of samples will be introduced to the intervention group by the doctor (principal researcher) after checking the conditions for entering the study and obtaining informed consent.
Allocation of samples in the intervention and control groups is done with random blocks.
Random blocks of 4 (28 blocks) and randomization is done using Sealed Envelope online service.

Allocation of samples to two intervention and control groups is done by another person from the plan (random block) and sent to the interventionists by SMS, Blinding description: Double blinding will be used in this study. The patients in both control and intervention groups will be given an educational DVD, and training sessions will be held for both groups, but the difference between the two groups is that in the intervention group, in addition to the usual treatment, breathing exercises will also be taught, but for The control group will only receive the usual treatment. Also, for double-blinding, the recipient of the spirometry test must be unaware of the patients' history.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients with COPD who receive breathing techniques. 2 sessions of regular treatment training and breathing exercise training (including 2 diaphragmatic breathing techniques, compressed lip breathing) along with regular individual treatment by a specialist. Along with the training DVD including these 2 techniques, each person is required to do these exercises at home 3 times a day for 10 minutes each time. In addition, this group has the requirements of the control group in addition to its own requirements. Follow-up and evaluation of patients will be done at the beginning of the study and 2 months after the intervention. Patients are examined once at the beginning of the study and again after 2 months (the end of the study). Patients are contacted by phone every week to ensure that breathing exercises are performed. Intervention 2: Control group: patients with COPD who received 2 sessions of regular treatment training (including how to use drugs and short-acting sprays and other recommendations) individually by a specialist. Along with an educational DVD containing the same drug recommendations and a series of basic training. Follow-up and evaluation of patients will be done at the beginning of the study and 2 months after the intervention. Patients are examined once at the beginning of the study and again after 2 months (the end of the study). Patients are contacted by phone every week to ensure attendance at the usual treatment.</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>Kourosh Kabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences campus, Faculty of Medicine, above Art University, west end of Buali, Nebubot Square, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149969415</zip>
        <telephone>009834287359</telephone>
        <email>kabir.kourosh@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kourosh Kabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, University of Medical Sciences campus, above Art University, west end of Buali, Nebubot Square, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149969415</zip>
        <telephone>009834287359</telephone>
        <email>kabir.kourosh@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with age over 18 years old
Patients are diagnosed with moderate and severe COPD (gold=2 and gold=3)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients requiring hospitalization
Patients with presence of pulmonary infection
Patients with severe obesity (BMI equal to or above 35)
Patients that need to artificial oxygen
Patients have performed the respiratory physiotherapy before entering into the study
Patients with mild disease (gold=1)
Patients with very severe disease (gold=4)
Patients who are not trainable
Patients with obstructive sleep apnea disorder
Patients with cancer
Patients with neuromuscular weakness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease with acute lower respiratory infection</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: patients with COPD who receive breathing techniques. 2 sessions of regular treatment training and breathing exercise training (including 2 diaphragmatic breathing techniques, compressed lip breathing) along with regular individual treatment by a specialist. Along with the training DVD including these 2 techniques, each person is required to do these exercises at home 3 times a day for 10 minutes each time. In addition, this group has the requirements of the control group in addition to its own requirements. Follow-up and evaluation of patients will be done at the beginning of the study and 2 months after the intervention. Patients are examined once at the beginning of the study and again after 2 months (the end of the study). Patients are contacted by phone every week to ensure that breathing exercises are performed.</i_keyword>
      <i_keyword>Control group: patients with COPD who received 2 sessions of regular treatment training (including how to use drugs and short-acting sprays and other recommendations) individually by a specialist. Along with an educational DVD containing the same drug recommendations and a series of basic training. Follow-up and evaluation of patients will be done at the beginning of the study and 2 months after the intervention. Patients are examined once at the beginning of the study and again after 2 months (the end of the study). Patients are contacted by phone every week to ensure attendance at the usual treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: The beginning of the study, two months after the start of the study. Method of measurement: Quality of life Questionnaire (Clinical COPD Questionnaire).</prim_outcome>
      <prim_outcome>Respiratory indicators. Timepoint: The beginning of the study, two months after the start of the study. 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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-29</approval_date>
        <contact_name>Research Ethics Committees of Alborz University of Medical Sciences</contact_name>
        <contact_address>Secretariat of the Research Ethics Committee of the University, 2nd Floor,Alborz University of Medical Sciences Research and Technology Vice-Chancellor Building, Shahid Safarian St., Golshahr forty-five meters, Karaj Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
