<?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>IRCT20141124020064N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of pulmonary rehabilitation program on respiratory disorders and quality of life in chemical victims, Sardasht, Iran</public_title>
      <acronym></acronym>
      <scientific_title>Effect of pulmonary rehabilitation program on respiratory disorders and quality of life in chemical victims, Sardasht</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The allocation of people in the two groups will be randomly based on a random selection of random numbers. In this way, before and after the study, AB and AB randomized permutations are defined as control (A) and intervention (B) groups. Using a random number table of half the sample size, the single digit number is selected between zero and nine. The odd number will be the selection of two people in the AB group and the pair number will mean two people in the BA groups. In this way, a sequence of AB and BA will be selected, which will be the same for the two groups. On the other hand, the layout will be completely random and it will not be easy to determine which group to be grouped into.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Respiratory Disorders.</hc_freetext>
      <i_freetext>Intervention 1: First, after obtaining the consent and willingness of the injured to participate in the research, the questionnaires are completed and the preliminary data are collected. For each Individuals in the intervention group, the informed consent form will be filled out. Each participant first completed a demographic questionnaire form including the name (optional), age, gender, injury history, marital status, smoking and tobacco, education, job status, and income, and then a form of review of the quality of life of the St George will fill out a quality of life questionnaire for respiratory diseases.Self-reporting questionnaire for chronic lung patients is standardized and the time required to complete 10 minute. This questionnaire has 50 questions and 3 distentions. The sections include symptoms, activity, and impact on daily life. Questions are scanned from 0 to 100 and expressed as percentages. The higher the score, the worse the quality of life. The questionnaire will be completed again two months after the intervention.Participants are also asked to record their shortness of breath. The intensity of shortness of breath is measured by the Visual Analog Scale instrument once a month. This instrument is a visual instrument for measuring the degree of shortness of breath in the range of 0 to 100 mm. The zero number indicates that there is no shortness of breath and the number of 100 represents the maximum severity of the breathlessness. This tool will be completed again two months after the intervention. Then, from each of the Individuals in the intervention group, spirometery will be performed to determine the pulmonary function. Spirometry will be re-sampled two months later. Each participant is then asked to complete the six minute gap test. In this test, each sample is asked to walk for six minutes and the area traveled by each person will be recorded.The distance traveled will be measured again after two months And increasing the distance up to 54 meter will be a significant change. Intervention 2: Control group: After receiving the consent and willingness of the injured to participate in the research, the questionnaires are completed and the preliminary data are collected. For each research unit, the informed consent form will be filled out. Each person in the control group first completed a demographic questionnaire containing the name (optional), age, sex, injury history, marital status, smoking and tobacco, education, job status and income, and then a quality of life assessment form St. George fill in. The questionnaire will be completed again two months later.Participants are also asked to record their shortness of breath. The intensity of shortness of breath is measured by the VAS tool once a month. The tool will be completed again two months later. Then, each spirometric control group will be assigned to determine pulmonary function. Spirometery will be re-sampled two months later. Then, each of the control group samples are asked to complete the six minute interval test. In this test, each specimen is asked to walk for six minutes and the area traveled by each person will be recorded.</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:
The results of the research will be published as a scientific paper. The results will be announced to the beneficiary organizations.

When:
1 year

To whom:
Vice-Chancellor's Office for Research

Conditions:
evaluation

Where to obtain:
Vice-Chancellor's Office for Research

How to obtain:
Request from the research vice president

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereydoun Khayyeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat Highway, Below the Milad Tower</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8670 1000</telephone>
        <email>adminsite@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sulayman Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat Highway - next to Milad Tower</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8670 1000</telephone>
        <email>sulaymanqadiri@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Moderate to severe COPD
َAble to cooperate in pulmonary rehabilitation program
Writing and reading ability
Not having mental or psychological illness
No history of pulmonary disease before mustard exposure
Non smoker</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exit from study
No cooperation in 1 of education class
Increase of pulmonary disorders or decrease of FEV1 less than 30%</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COPD</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First, after obtaining the consent and willingness of the injured to participate in the research, the questionnaires are completed and the preliminary data are collected. For each Individuals in the intervention group, the informed consent form will be filled out. Each participant first completed a demographic questionnaire form including the name (optional), age, gender, injury history, marital status, smoking and tobacco, education, job status, and income, and then a form of review of the quality of life of the St George will fill out a quality of life questionnaire for respiratory diseases.Self-reporting questionnaire for chronic lung patients is standardized and the time required to complete 10 minute. This questionnaire has 50 questions and 3 distentions. The sections include symptoms, activity, and impact on daily life. Questions are scanned from 0 to 100 and expressed as percentages. The higher the score, the worse the quality of life. The questionnaire will be completed again two months after the intervention.Participants are also asked to record their shortness of breath. The intensity of shortness of breath is measured by the Visual Analog Scale instrument once a month. This instrument is a visual instrument for measuring the degree of shortness of breath in the range of 0 to 100 mm. The zero number indicates that there is no shortness of breath and the number of 100 represents the maximum severity of the breathlessness. This tool will be completed again two months after the intervention. Then, from each of the Individuals in the intervention group, spirometery will be performed to determine the pulmonary function. Spirometry will be re-sampled two months later. Each participant is then asked to complete the six minute gap test. In this test, each sample is asked to walk for six minutes and the area traveled by each person will be recorded.The distance traveled will be measured again after two months And increasing the distance up to 54 meter will be a significant change.</i_keyword>
      <i_keyword>Control group: After receiving the consent and willingness of the injured to participate in the research, the questionnaires are completed and the preliminary data are collected. For each research unit, the informed consent form will be filled out. Each person in the control group first completed a demographic questionnaire containing the name (optional), age, sex, injury history, marital status, smoking and tobacco, education, job status and income, and then a quality of life assessment form St. George fill in. The questionnaire will be completed again two months later.Participants are also asked to record their shortness of breath. The intensity of shortness of breath is measured by the VAS tool once a month. The tool will be completed again two months later. Then, each spirometric control group will be assigned to determine pulmonary function. Spirometery will be re-sampled two months later. Then, each of the control group samples are asked to complete the six minute interval test. In this test, each specimen is asked to walk for six minutes and the area traveled by each person will be recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reducing respiratory problems means that pulmonary volumes increase and dyspnea is reduced. An increase in the quality of life score that reflects its improvement. Timepoint: 2 month. Method of measurement: St George Respiratory Questionnaire, Spirometery, 6 Minute Walking Test, Visual Analogue Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-21</approval_date>
        <contact_name>Iran University of Medical Sciences Ethical Committee</contact_name>
        <contact_address>Rashid Yasemi St., Vali-e-Asr St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
