<?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>IRCT20251122068071N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of inspiratory breathing exercises in patients with lower limb venous insufficiency</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of inspiratory breathing exercises on the quality of life and vascular flow of patients with lower limb venous insufficiency referred to Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87641</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method, individual randomization unit, randomization tool: random number table, double blind. For randomization, the Simple Randomization method is used using a random number table. For this purpose, two groups (A, B) are considered. We choose one of the rows of the random number table at will and we know that the numbers in each row will be between 0 and 9. Then we assign the numbers 0-4 to treatment A and the numbers 5-9 to treatment B. Suppose the numbers for the first row are as follows: 0, 5, 2, 7, 8, 4. Therefore, the number 0 is assigned to treatment A, the number 5 to treatment B, the number 2 to treatment A, .... Therefore, the first person receives treatment A, the second person receives treatment B , Blinding description: Patients are not aware that the IMT device is the main component of the intervention. Both groups have exercises, so no obvious sense of difference is created. Also, the vascular surgeon is blinded to the group allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>Lower Limb Venous Insufficiency.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the control group, calf muscle strengthening exercises will be performed three sessions per week as routine care, with calf strengthening exercises performed two sessions per week in three sets and 10 repetitions; for the first month, three gastrosoleus stretches, two-legged cuff raises while sitting on a chair, and two-legged cuff raises on a flat surface will be performed; in the second month of intervention, three exercises: single-legged cuff raises on a flat surface, two-legged cuff raises on a board, and tiptoe walking for three to one minute will be added to the previous exercises. Intervention 2: Intervention group: In the intervention group, in addition to calf muscle strengthening exercises, patients will be given inspiratory breathing exercises using the IMT device for 8 weeks, five days per week, twice a day, and 30 breaths per session, with a gradual increase in the degree of difficulty (one degree per week).</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 no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roya Ghazvineh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen St., Shahid Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۱۱۵۱</zip>
        <telephone>+98 21 2303 1505</telephone>
        <email>dr.ghazvineh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Hossein Abedi Yekta</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen St., Shahid Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2243 9865</telephone>
        <email>Abedi_yekta@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 65 years
Having informed consent to participate in the study
No previous experience with breathing exercises or other similar protocols
Definitive diagnosis of lower extremity venous insufficiency</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient's unwillingness to continue participating in the study
Deterioration of the patient's condition or death before the end of the 2-month study period
Initiating new treatment protocols for the patient that interfere with inspiratory breathing exercises.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I87.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Venous insufficiency (chronic) (peripheral)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the control group, calf muscle strengthening exercises will be performed three sessions per week as routine care, with calf strengthening exercises performed two sessions per week in three sets and 10 repetitions; for the first month, three gastrosoleus stretches, two-legged cuff raises while sitting on a chair, and two-legged cuff raises on a flat surface will be performed; in the second month of intervention, three exercises: single-legged cuff raises on a flat surface, two-legged cuff raises on a board, and tiptoe walking for three to one minute will be added to the previous exercises.</i_keyword>
      <i_keyword>Intervention group: In the intervention group, in addition to calf muscle strengthening exercises, patients will be given inspiratory breathing exercises using the IMT device for 8 weeks, five days per week, twice a day, and 30 breaths per session, with a gradual increase in the degree of difficulty (one degree per week).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention and after the end of eight weeks of intervention. Method of measurement: Quality of life questionnaire for patients with venous insufficiency.</prim_outcome>
      <prim_outcome>Venous refilling time. Timepoint: Quality of life questionnaire for patients with venous insufficiency. Method of measurement: Plethysmography.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-11-05</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Yemen St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
