<?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>IRCT20200310046739N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-14</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of a short-term walking after meals in improving gastrointestinal symptoms in individuals with functional abdominal bloating</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of a short-term walking after meals versus the use of prokinetic medications in improving gastrointestinal symptoms in individuals with functional abdominal bloating: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50236</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The process of randomization and allocation will be performed by an independent external researcher. The participants are randomized into two groups of intervention and control with the allocation rate of 1:1. The randomization process will be provided by a web-based randomization application (https://app.studyrandomizer.com/) which which generated a simple randomization sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Functional Abdominal Bloating.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The subjects in the intervention group were asked to perform a particular exercise after each meal. All the intervention group participants had to install Pedometer Step Counter application on their smartphones (https://play.google.com/store/apps/details?Id=pedometer.steptracker.calorieburner.stepcounter&amp;hl=en). This exercise consists of 10-15 minutes of slow walking (reaching 1000 steps), walking with hand clasped together behind the body and flexed neck (around 45 degree) posture without talking meanwhile. Intervention 2: Control group: Individuals were given daily domperidone  plus activated dimethicone as a prokinetic medication(10 mg, 30 mins before lunch and dinner).</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 There is a possibility that we use this data for another study, too.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Erfan Taherifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>MPH department, 8 floor, Shahid Gorgani nezhad building, School of medicine, Imam Hossein Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 21 8670 5503</telephone>
        <email>Erfantaherifard@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Erfan Taherifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>MPH department, 8 floor, Shahid Gorgani nezhad building, School of medicine, Imam Hossein Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 21 8670 5503</telephone>
        <email>erfantaherifard@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who meet the Rome IV criteria as diagnostic criteria for functional bloating/distension are included in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with history of anorexia, weight loss, alteration in bowel habit, chronic diarrhea and upper/lower gastrointestinal bleeding over the past 3 months are excluded from the study
Patients with alarming points in physical examination including jaundice, organomegaly, ascites and temporal wasting are excluded
Individuals are not included in the study if they had any abnormal laboratory workup indicating an underlying disorder, body mass index ≥40, a history of GI or abdominopelvic surgery or significant coexisting medical condition or medications that affect GI tract motility
Furthermore, those subjects that were pregnant are excluded from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R14.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abdominal distension (gaseous)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The subjects in the intervention group were asked to perform a particular exercise after each meal. All the intervention group participants had to install Pedometer Step Counter application on their smartphones (https://play.google.com/store/apps/details?Id=pedometer.steptracker.calorieburner.stepcounter&amp;hl=en). This exercise consists of 10-15 minutes of slow walking (reaching 1000 steps), walking with hand clasped together behind the body and flexed neck (around 45 degree) posture without talking meanwhile.</i_keyword>
      <i_keyword>Control group: Individuals were given daily domperidone  plus activated dimethicone as a prokinetic medication(10 mg, 30 mins before lunch and dinner)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Belching. Timepoint: Before intervention and 4 weeks after study intervention. Method of measurement: Using a 5-point Likert scale (1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe).</prim_outcome>
      <prim_outcome>Postprandial epigastric fullness/bloating. Timepoint: Before intervention and 4 weeks after study intervention. Method of measurement: Using a 5-point Likert scale (1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe).</prim_outcome>
      <prim_outcome>Abdominal discomfort/pain. Timepoint: Before intervention and 4 weeks after study intervention. Method of measurement: Using a 5-point Likert scale (1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe).</prim_outcome>
      <prim_outcome>Flatus. Timepoint: Before intervention and 4 weeks after study intervention. Method of measurement: Using a 5-point Likert scale (1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-01</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Research and technology department, Administration Building of Shiraz University of Medical Sciences  Zand St. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
