<?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>IRCT2015102224646N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-10</date_registration>
      <primary_sponsor>Nursing School, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of effect of incentive abdominal breathing device with normal abdominal breathing on the respiratory condition of chronic obstructive</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of effect of incentive abdominal breathing device with normal abdominal breathing on the respiratory condition of chronic obstructive pulmonary disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20775</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</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: In the experimental group, the incentive abdominal breathing device to the patient's abdomen is closed. Then to 100 times (in 10 steps) to do abdominal breathing. This means that with the expansion of the abdominal muscles, the air inside the plastic tube into the balloon And in between each 10 abdominal breathing, take a minute to do normal breathing.  Interventions do 14 days and twice a day in the morning and evening. Intervention 2: In the control group, patients one hand on his/her stomach and put other hand on chest And 100 times (in 10 steps) do abdominal breathing so that the chest have the largest and abdomen have least displacement. Among the 10 abdominal breathing, take a minute to do normal breathing. Interventions do 14 days and twice a day in the morning and evening.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Golmohammadi Kavaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Doktora crossroads, Mashhad, Khorasan Razav</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 4612 5301</telephone>
        <email>golmohammadikm921@mums.ac.ir</email>
        <affiliation>Mashhad School of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haji Mohmmad Norouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Crossroads Doktora, Mashhad, Khorasan Razav</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Norozihm@mums.ac.ir</email>
        <affiliation>Mashhad School of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: For inclusion is satisfied; Chronic obstructive pulmonary disease has been approved by a pulmonary specialist and clinical results; FEV1 less than 80 percent of the index predicted and FEV1 / FVC ratio less than 70 percent;  no Signs of lung infection, according psychiatrists lung; Aged 18 to 65 years; Not having a size too large or too small; No history of chest and abdominal surgery; No history of neuromuscular disorders; Lack of heart disease. Exclusion criteria: Respiratory infection and fever while studying; Deterioration of the patient or require hospitalization for any reason; The risk of heart problems and cardiac involvement during the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j47</hc_code>
      <hc_code>J40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic lower respiratory diseases</hc_keyword>
      <hc_keyword>Chronic lower respiratory diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experimental group, the incentive abdominal breathing device to the patient's abdomen is closed. Then to 100 times (in 10 steps) to do abdominal breathing. This means that with the expansion of the abdominal muscles, the air inside the plastic tube into the balloon And in between each 10 abdominal breathing, take a minute to do normal breathing.  Interventions do 14 days and twice a day in the morning and evening.</i_keyword>
      <i_keyword>In the control group, patients one hand on his/her stomach and put other hand on chest And 100 times (in 10 steps) do abdominal breathing so that the chest have the largest and abdomen have least displacement. Among the 10 abdominal breathing, take a minute to do normal breathing. Interventions do 14 days and twice a day in the morning and evening.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FEV1. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>FVC. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>FEV1/FVC. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>PEFR. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>MIP. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>MVV. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>Tidal volume. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: numerical rating scale of Dyspnea.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: registration forms spirometric indices.</prim_outcome>
      <prim_outcome>Disease severity. Timepoint: Before the intervention, day 7, the end of the study (day 14). Method of measurement: copd assesment test( cat).</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>Nursing School, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-05</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Qureshi building, university St., Mashhad, Khorasan Razavi Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
