<?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>IRCT20161004030141N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-04</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Local heat Therapy on the Respiratory Indicators and Fatigue</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of  Local heat Therapy on the Respiratory Indicators and Fatigue in  Patients with Chronic Obstructive Pulmonary Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43006</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be divided into two experimental and control groups based on permutation blocks. Six possible modes will be listed randomly and after determining the number of blocks, individuals will be allocated to the experimental and control groups, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Obstructive Pulmonary Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in this group will be used a hot pack for topical heat therapy, a special 25×35 standard linen bag containing hydrophilic silicate and charged by a hydrocollator up to 50 ° C. Then the hot pack will be placed in a special towel and used in anterior part of chest for 23 minutes twice a day every, heat therapy will continue for five days. Heat therapy will continue for five days. Intervention 2: Control group: in this group will be used a hot pack for topical heat therapy, a special 25×35 standard linen bag containing hydrophilic silicate and charged by a hydrocollator up to 37° C. Then the hot pack will be placed in a special towel and used in anterior part of chest for 23 minutes twice a day every, heat therapy will continue for five days. Heat therapy will continue for five days.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masume ُُShahpasand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Asian Road, Gonabad University of Medical Sciences, Gonabad, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>shahpasand.m@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Mohammadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۶۹۱۷۹۳۷۱۸</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>amohmmadpur@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Stage of 1-4 in Chronic obstructive pulmonary disease according to GOLD criteria
BMI between 18.5-25 kg/m2
Alertness, ability to speak and communicate
Stable physiological status for answer questions</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of lesions (swelling, sores, scratches, and redness) in the chest area
Structural disorder and deformity in the chest area
The history of mental disorder and hyperthyroidism based on patient reports
The presence of cardiac arrhythmia
Spirometric contraindication conditions (uncontrolled hypertension, contagious respiratory infection, active hemoptysis, recent eye or ear surgery, rupture of tympan, the recent CVA or pulmonary embolism, the history of myocardial infarction or unstable angina in recent 6 weeks)</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in this group will be used a hot pack for topical heat therapy, a special 25×35 standard linen bag containing hydrophilic silicate and charged by a hydrocollator up to 50 ° C. Then the hot pack will be placed in a special towel and used in anterior part of chest for 23 minutes twice a day every, heat therapy will continue for five days. Heat therapy will continue for five days.</i_keyword>
      <i_keyword>Control group: in this group will be used a hot pack for topical heat therapy, a special 25×35 standard linen bag containing hydrophilic silicate and charged by a hydrocollator up to 37° C. Then the hot pack will be placed in a special towel and used in anterior part of chest for 23 minutes twice a day every, heat therapy will continue for five days. Heat therapy will continue for five days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vital Capacity. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Force Vital Capacity. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Forced Expiratory Volume in First Second. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Peak Expiratory Flow Rate. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Forced expiratory flow at 25-75% of vital capacity. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>FEV1/FVC. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Number per minute.</prim_outcome>
      <prim_outcome>Oxygen saturation percentage (SPO2). Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Pulse Oximeter Device.</prim_outcome>
      <prim_outcome>Fatigue severity. Timepoint: At baseline (before intervention), 6 days after first intervention. Method of measurement: Crop 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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-03</approval_date>
        <contact_name>Ethics committee in Gonabad University of Medical Science</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Next to the Asian road, Gonabad, Khorasan Razavi Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
