<?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>IRCT20180418039348N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-14</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rehabilitation on respiratory symptoms and lung function indexes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rehabilitation (strength and endurance exercises) on respiratory symptoms, lung function indexes and some inflammatory mediators in asthmatic patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31168</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention group: Exercise exercises will be done for 4 weeks (3 sessions per week). During each session after warming up, for 10 minutes, endurance training includes treadmills, bicycle and arm ergonomic for 15-20 minutes with Vo2 max = 60% for Elementary sessions, and gradually 60 minutes with Vo2 max = 70-80% for final sessions. Upon completion of endurance training, resistance training include weight lifting. In this exercise, one repetition maximum of the person is calculated first and 50-60% of the 1RM for a set with 15-10 repeats. Gradually, the number of sets will reach 3. Static stretching of the entire body and finally cool down for 10 minutes..</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 After completion of the project, will be decided.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Boskabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Departement of Physiology - Mashhad University of Medical Sciences - Azadi Square - Mashhad - Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9766167367</zip>
        <telephone>+98 51 3882 8883</telephone>
        <email>boskabadij901@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad hosein Boskabady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Departement of Physiology - Mashhad University of Medical Sciences - Azadi Square - Mashhad - Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3882 8883</telephone>
        <email>boskabadymh@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mild to moderate bronchial asthma disease based on spirometric testing and having clinical symptoms of respiratory tract
Absence of acute illnesses that are in contradiction with exercise
Age limit 20 to 60 years
Giving written consent
Having a commitment to doing research steps</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe asthma that is exacerbated by exercise
Acute diseases that are exacerbated by exercise
Cardiovascular disease
Chronic inflammatory diseases
Acute infections
Malignant diseases
Having autoimmune diseases and immune deficiency</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Asthma</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>J45</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Exercise exercises will be done for 4 weeks (3 sessions per week). During each session after warming up, for 10 minutes, endurance training includes treadmills, bicycle and arm ergonomic for 15-20 minutes with Vo2 max = 60% for Elementary sessions, and gradually 60 minutes with Vo2 max = 70-80% for final sessions. Upon completion of endurance training, resistance training include weight lifting. In this exercise, one repetition maximum of the person is calculated first and 50-60% of the 1RM for a set with 15-10 repeats. Gradually, the number of sets will reach 3. Static stretching of the entire body and finally cool down for 10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement in respiratory status and spirometry tests. Timepoint: At the beginning of the study and 30 days after the start of the study. Method of measurement: Measurement with using a spirometer device and pulmonary function tests.</prim_outcome>
      <prim_outcome>Measuring cytokines and inflammatory mediators ( such as IgE ، IgG TNFα, IL-6 and IL-8 ) in serum. Timepoint: At the beginning of the study and 30 days after the start of the study. Method of measurement: Use of special kits and protocols.</prim_outcome>
      <prim_outcome>Total number and types of white blood cells in the blood. Timepoint: At the beginning of the study and 30 days after the start of the study. Method of measurement: Using a special laboratory device for counting white blood cells.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measurement concentration of fractional exhaled nitric oxide (FeNO). Timepoint: At the beginning of the study and 30 days after the start of the study. Method of measurement: Use of special kits and protocols.</sec_outcome>
      <sec_outcome>Measurement  of C-reactive protein (CRP). Timepoint: At the beginning of the study and 30 days after the start of the study. Method of measurement: Use of special kits and protocols.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-04</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی مشهد</contact_name>
        <contact_address>مشهد، بلوارشهید فکوری، حدفاصل میدان شهیدجوان وآل شهیدی، شهرك دانش وسلامت Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
