<?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>IRCT20171006036584N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-07</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Upper Limb Exercise and Respirotary Training on Outcome of COPD Patient</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the  Effectiveness of Upper Limb Exercise and Respirotary Training on Outcome of COPD Patients in Selected  Medical Centers of Qazvin Science Medicine University.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27304</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Eligible patients (according to the inclusion criteria), then the patient will choose 75 blocks of a trio of three groups: upper limb exercise, breathing exercises and group controlling in the following five modes::
(Upper extremity exercise, breathing exercises, control)
(Breathing exercises, upper extremity exercise, control)
(Control, respiratory exercises, exercise upper limbs)
(Breathing exercises, upper extremity exercise, control)
(Upper extremity exercise, control, respiratory exercises)
And then, based on the table of random numbers each of these groups will be selected. for example, if the number is one, the first will select the combination or if the number two will be selected and combined the two came to the patient's respiratory exercises for a group of up to 25, 25 of the patient for group exercise of limbs The patient's upper and 25 for the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Obstructive Pulmonary Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: respiratory exercises on a regular basis that includes: a bud lips breathing and breathing is diaphragmy by three one-hour sessions on research during three consecutive days for a person and face to face training will be given to patients. After getting more information, respiratory exercises checklist to the target group will be given up to every day after doing exercises, in the appropriate section of mark. this group has 25 people and exercises daily for one month for 20 minutes and four times a day (morning, afternoon, evening, night) and patients will do a minute pattern of practice and two minute break will be given training exercises conducted daily tracking order by a researcher for the phone call up to four weeks. 2. upper extremity exercise group: 25 second sample in this group. After collecting the number of samples as previously mentioned research objectives with the briefing outlines and do the work for the patients of this group will be formed and after getting a written consent, completing a questionnaire, demographic information, St. George's quality of life questionnaire for all patients. 6-minute walk test in consecutive two days for this group such as the previous group will be conducted. Intervention 2: Control group: 25  patients will be put  in the control group. Similar to the intervention group, after explaining the research goals for each patient after completing the consent form, the demographic questionnaire and the questionnaire of the quality of life of St. George and 6-minute walk  compared to complete. The usual care control group will be placed to avoid ethical problems. After completion of the study, the results of research will also presented to the control group. In the event of any change in personal life and work or any  important changes either good or bad, such as the loss of a job or members of the family and marriage that makes changing the quality of life, it would be stated to the researcher. It should be noted at the end of the study in each group to compare the results St. George's quality of life questionnaire for all samples would be tested and also completed 6 minute walk.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Given the multiple variables measured, and given that the data ultimately result in several articles, I do not plan to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Omolbanin Keshavarz Sarkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat Hospital</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3323 7267</telephone>
        <email>O.Keshavarzsarkar@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Liela Yekefallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar Blv, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3323 7267</telephone>
        <email>leili_fallah@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with copd referred to lung clinic of Qazvin Ve Hospital aged 30 to 90 years
Average and Sever COPD Diagnosis by a Physician and Refering to the Researcher in a Written Format.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>exacerbation of the disease so that it misses the company exercises.
advanced cardiovascular disease.
catching a nerve disorder that is in conflict with the muscle-have exercises.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other chronic obstructive pulmonary disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: respiratory exercises on a regular basis that includes: a bud lips breathing and breathing is diaphragmy by three one-hour sessions on research during three consecutive days for a person and face to face training will be given to patients. After getting more information, respiratory exercises checklist to the target group will be given up to every day after doing exercises, in the appropriate section of mark. this group has 25 people and exercises daily for one month for 20 minutes and four times a day (morning, afternoon, evening, night) and patients will do a minute pattern of practice and two minute break will be given training exercises conducted daily tracking order by a researcher for the phone call up to four weeks. 2. upper extremity exercise group: 25 second sample in this group. After collecting the number of samples as previously mentioned research objectives with the briefing outlines and do the work for the patients of this group will be formed and after getting a written consent, completing a questionnaire, demographic information, St. George's quality of life questionnaire for all patients. 6-minute walk test in consecutive two days for this group such as the previous group will be conducted.</i_keyword>
      <i_keyword>Control group: 25  patients will be put  in the control group. Similar to the intervention group, after explaining the research goals for each patient after completing the consent form, the demographic questionnaire and the questionnaire of the quality of life of St. George and 6-minute walk  compared to complete. The usual care control group will be placed to avoid ethical problems. After completion of the study, the results of research will also presented to the control group. In the event of any change in personal life and work or any  important changes either good or bad, such as the loss of a job or members of the family and marriage that makes changing the quality of life, it would be stated to the researcher. It should be noted at the end of the study in each group to compare the results St. George's quality of life questionnaire for all samples would be tested and also completed 6 minute walk.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>St. George's special quality of life questionnaire that  is used for respiratory ailments. Rating of the questionnaire for every incumbent has from zero to 100, and the total inventory is defined in such a way that the number zero, indicates full health and gradually increase it to a lower quality of life. Timepoint: measurement processes in this study would be at the beginning of the study, then after 30 days of interventions and then the final measurement is done again. Method of measurement: 1. Demographic information form, 2. St. George's quality of life questionnaire 3.  Performing 6-minute walk test 4.  Self- reporting checklist 5.  Upper extremity exercise checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>6-minute walk test that documented in selected Medical Center ( Velayat hospital) will be used. This form has 5 questions in the field of walking and finally the amount of mileage of the patient record. Timepoint: Levels measured in this study was the first study in the first 30 days and then do the interventions are done, and then the final measurement is done again. Method of measurement: The test would be carried out in Velayat Hospital (formerly in the Department of the Interior has been measuring men) within 6 minutes, will during the mileage rate and will be recorded by the researcher.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-27</approval_date>
        <contact_name>Ethics commitee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Shahid Bahonar Blv, Qazvin Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
