<?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>IRCT2016051127848N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-24</date_registration>
      <primary_sponsor>Health Department of Foundation of Martyrs and Veterans Affairs</primary_sponsor>
      <public_title>Pulmonary rehabilitation in chemical victims</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Pulmonary rehabilitation effects on skeletal muscle condition, pulmonary function and quality of life in victims of chemical warfare</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22728</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the participants according to the inclusion and exclusion criteria, baseline assessments will be performed .The participants will be randomized into two control and intervention groups. The random sequence will be determined from the randomization website (http://www.jerrydallal.com/random/permute.htm) in blocks of four, Blinding description: The technicians who are responsible for randomization ,  the assessors and the safety committee and data monitoring are blind to the study.The two groups are identified by letters A and B. In order to protect confidentiality in all stages of the trial, each participant will be assigned a unique identification code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic respiratory disorders due to sulfur mustard inhalation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: Pulmonary rehabilitation will be a mix of aerobic endurance training and strength training as well as education in self management. Patients will attend 3 times per week for 6 weeks. Intervention 2: Control: usual treatment without any additional intervention.</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 total potential data can be shared after unidentifiable people.

When:
The start of the access period is one year after the publication of the results.

To whom:
Data will only be available to researchers in universities and scientific centers .

Conditions:
Applicants must announce their goals and plans on how to use the data to be decided on by case basis.

Where to obtain:
Janbazan Medical and Engineering Research Center (JMERC), NO.17, Farrokh St., Moghaddas Ardebily Ave., Chamran Highway, Tehran, Iran	Tehran	Iran
Phone: +98 2122415367
Fax: +98 2122418180
http://www.jmerc.ac.ir

How to obtain:
The request is submitted to the supervisor through JMERC. In case of initial agreement, the Reaserch Committee will make the final decision.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Reza Sedighi Moghadam MD. MPH</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 17,Farokh Street,Moghadas Ardebili Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1933934933</zip>
        <telephone>+98 21 2241 5367</telephone>
        <email>moghadam_office@yahoo.com</email>
        <affiliation>Janbazan Medical Engineering Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Ghanei MD.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>12th Frvardin Street, Enghelab Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>+66 954321</telephone>
        <email>mghaneister@gmail.com</email>
        <affiliation>Pasteur Institute of Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with history of sulfur mustard exposure
FEV1 lower than 80% predicted
MRC dyspnoea score ≥ 3</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis
any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases
the presence of other non-chemical related pulmonary diseases like asthma
active malignancy
severe cognitive disorder and psychiatric disease that is associated with memory disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J68.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic respiratory conditions due to chemicals, gases, fumes and vapors</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: Pulmonary rehabilitation will be a mix of aerobic endurance training and strength training as well as education in self management. Patients will attend 3 times per week for 6 weeks.</i_keyword>
      <i_keyword>Control: usual treatment without any additional intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endurance Time. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using an electronically braked cycle ergometer at 70% of Wmax to volitional exhaustion.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lung flows and volumes. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using body plethysmography.</sec_outcome>
      <sec_outcome>Single-breath diffusing capacity. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using DLCO.</sec_outcome>
      <sec_outcome>Vo2max. Timepoint: before intervention. Method of measurement: by using ergospirometry.</sec_outcome>
      <sec_outcome>Quadriceps muscle strength. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using Biodex: Participants will perform 30 sequential volitional maximal contractions at an angular velocity of 90°/s, while seated upright and with the hip joint in 90° of flexion. Quadriceps muscle strength was defined as the highest peak torque (Newton-meter (Nm)).</sec_outcome>
      <sec_outcome>AT. Timepoint: before intervention. Method of measurement: by using ergospirometry.</sec_outcome>
      <sec_outcome>O2 pulse. Timepoint: before intervention. Method of measurement: by using ergospirometry.</sec_outcome>
      <sec_outcome>Quadriceps muscle endurance. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using Biodex: Participants will perform 30 sequential volitional maximal contractions at an angular velocity of 90°/s, while seated upright and with the hip joint in 90° of flexion. Quadriceps muscle endurance was defined as the total amount of delivered work (Joules (J)) during the set of 30 repetitions.</sec_outcome>
      <sec_outcome>Cross-sectional area of the rectus femoris (RFCSA). Timepoint: before intervention , 6th week, 12th month. Method of measurement: by Cross-sectional area of the rectus femoris (RFCSA) will be measured by B-mode ultrasonography using an 8 MHz 5.6 cm linear transducer, similar to the method of de Bruin et al.</sec_outcome>
      <sec_outcome>FFM. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using single-frequency BIA (Bioelectrical Impedance Analyser).</sec_outcome>
      <sec_outcome>BMI. Timepoint: before intervention , 6th week, 12th month. Method of measurement: weight(kg)/height^2(m^2).</sec_outcome>
      <sec_outcome>Total distance walked during 6 minutes. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using 6MWT.</sec_outcome>
      <sec_outcome>Anxiety and Depression. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using HADS.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using SGRQ.</sec_outcome>
      <sec_outcome>Number of exacerbations  (defined as episodes of increased respiratory symptoms requiring a change in medication). Timepoint: monthly. Method of measurement: by asking the patient.</sec_outcome>
      <sec_outcome>Number of hospitalization due to respiratory diseases. Timepoint: monthly. Method of measurement: by asking the patient and reviewing medical records.</sec_outcome>
      <sec_outcome>GH. Timepoint: before intervention. Method of measurement: Lab Test.</sec_outcome>
      <sec_outcome>IGF-1. Timepoint: before intervention. Method of measurement: Lab Test.</sec_outcome>
      <sec_outcome>High sensitivity CRP. Timepoint: before intervention. Method of measurement: Lab Test.</sec_outcome>
      <sec_outcome>Testosterone. Timepoint: before intervention. Method of measurement: Lab Test.</sec_outcome>
      <sec_outcome>Distance of daily walking. Timepoint: a week before intervention, 7th week and 12th month. Method of measurement: by using pedometer.</sec_outcome>
      <sec_outcome>Healthcare utilisation. Timepoint: at the end of study. Method of measurement: according to medical records.</sec_outcome>
      <sec_outcome>Dyspnea. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using Borg Scale.</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: before intervention , 6th week, 12th month. Method of measurement: by using Borg Scale.</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>Health Department of Foundation of Martyrs and Veterans Affairs</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-20</approval_date>
        <contact_name>Organizational Committee of Ethics in Biomedical Research Foundation of Martyrs and Veterans Affairs</contact_name>
        <contact_address>No 17,Farokh Street,Moghadas Ardebili Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
