<?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>IRCT2014041617299N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-19</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of care program on Asthma control and quality of life</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of a designed care program by cases without intervention on control of asthma and quality of life in 60 patients with asthma referring to selected clinics of Shiraz university of medical sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15946</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Block randomization method is presented.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The rehabilitation-educational classes were held according to pre-recorded training schedule for the intervention group as 4-6 sessions of 60 minutes for one month (depending on training needs, understanding of each individual and their educational level, the length of the class time may increase). Educational items include: understanding the disease and its pathophysiology, allergens, drug treatments and their side effects, using spray correctly and teaching effective coughing, effective exercise techniques, and self-care. In addition, pulmonary rehabilitation was provided under the supervision of a specialist in physical medicine as moderate-intensity aerobic exercise 6-5 days per week, each time 30 minutes for large muscle groups and correct posture and contraction of the shoulder, shrugging and rotating of shoulders, stretching the shoulder girdle, spinal cord, and intercostals muscles, exercising deep breath and holding it, along with relaxation training. The participants were given pamphlets. Follow-up phone calls were conducted by the researcher to control their abeyance from the care program. Intervention 2: The control group received routine care and education. Also at the end of the study, the control group also runs a training program and manual were awarded to them.</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>Zahra Molazem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat-e-Fatemeh nursing and midwifery College, Namazi Hospital, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1978</zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>Molazemzah@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Molazem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh (p.b.u.h) School of Nursing and Midwifery, Namazi Hospital, Namazi Sq., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>Molazem@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
1) patients with asthma disease after approval by the relevant specialist. &#13;
2) In asthmatic patients, age range 19 -65 years. &#13;
3) they wish to participate in the study. &#13;
4) Failure to participate in similar programs in the past 6 months. &#13;
5) absence of other known chronic condition that requires special care and different programs. &#13;
Exclusion criteria were: &#13;
1) having muscle problems, bone defects, heart disease - cardiovascular diseases, pregnancy or acute diseases that may be incompatible with the exercise. &#13;
2) lack of cooperation and participation in the study. &#13;
3) absence of two or more training sessions.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>asthma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The rehabilitation-educational classes were held according to pre-recorded training schedule for the intervention group as 4-6 sessions of 60 minutes for one month (depending on training needs, understanding of each individual and their educational level, the length of the class time may increase). Educational items include: understanding the disease and its pathophysiology, allergens, drug treatments and their side effects, using spray correctly and teaching effective coughing, effective exercise techniques, and self-care. In addition, pulmonary rehabilitation was provided under the supervision of a specialist in physical medicine as moderate-intensity aerobic exercise 6-5 days per week, each time 30 minutes for large muscle groups and correct posture and contraction of the shoulder, shrugging and rotating of shoulders, stretching the shoulder girdle, spinal cord, and intercostals muscles, exercising deep breath and holding it, along with relaxation training. The participants were given pamphlets. Follow-up phone calls were conducted by the researcher to control their abeyance from the care program.</i_keyword>
      <i_keyword>The control group received routine care and education. Also at the end of the study, the control group also runs a training program and manual were awarded to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Asthma Control. Timepoint: Before the intervention, immediately after intervention, two Months after treatment. Method of measurement: Peak flow meter, Asthma Control Test.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention, immediately after intervention and two months after treatment. Method of measurement: Asthma Quality of Life Questionnaire.</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>Vice Chancellor for Research, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-15</approval_date>
        <contact_name>Shiraz University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Vice Chancellor for Research, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
