<?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>IRCT20160704028776N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-14</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of manual lymph drainage and exercise</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of manual lymph drainage and exercise in patients with lymphedema</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80361</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lymphedema.</hc_freetext>
      <i_freetext>Intervention 1: Manual lymph drainage group: In this study, one session of manual lymph drainage lasts for 2-3 hours, the most important part of manual lymph drainage is to identify the areas that need to be drained and also to identify healthy and necessary lymphatic pathways. These pathways and lymph nodes are used to change the path of protein-rich lymph fluid from the organ or the swollen part of the body to the venous system. The basis of the technique of manual lymph drainage is the basic strokes, which are: Rotary, pump, stationary circle, scoop. The common feature of all four techniques is having two phases, including the working or pressing phase and the rest or relaxing phase. All of these techniques are applied from the center to the periphery, in such a way that first the proximal areas are drained in order to prepare for the liquid collected in the distal parts. In the working phase of each stroke, the stimuli A stretch is applied to the subcutaneous tissue. The pressure in this phase should be so much that it causes the subcutaneous tissue to stretch on the underlying fascia to the extent of its elastic capacity. Applying gentle and directional pressure during the work phase causes the movement of lymph fluid in the right direction and causes the lymph to drain in the desired direction. The best result is achieved when each work phase lasts one second and 5 to 7 times at each point in a fixed pattern. Or a varied pattern is repeated. Intervention 2: Intervention group: exercise: In this study, patients exercise for one session and for a duration of 30 minutes according to the therapeutic exercise protocol. The patients' exercise protocol includes diaphragmatic breathing, stretching exercises of the upper limbs, including stretching of the flexor and extensor muscles of the arm and wrist; The patient keeps each stretching exercise for 15-30 seconds and repeats two sets of three. While performing diaphragmatic breathing, the patient's position is such that the patient's fingers are placed in front of the sternum and the patient starts performing diaphragmatic breathing. When performing exercises, compression bandages or compression bandages should be used. Tight and restrictive clothes should not be used during exercise. Movements should be slow and controlled.</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 After sampling and evaluating the patients, I will make a decision on this matter</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Mohsen Roostae</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehranر</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 2057</telephone>
        <email>roosta@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Mohsen Roostae</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 2057</telephone>
        <email>roosta@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with lymphedema who have been referred to the physiotherapy clinic by radiotherapy and oncology specialists
Women aged 25 to 65 years
No heart problems
Absence of aortic aneurysm
Absence of any musculoskeletal-neurological disorder that is not related to the complications of cancer
Absence of autoimmune diseases such as rheumatoid arthritis</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>68 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The patient's lack of consent to cooperate at any stage of the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postmastectomy lymphedema syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Manual lymph drainage group: In this study, one session of manual lymph drainage lasts for 2-3 hours, the most important part of manual lymph drainage is to identify the areas that need to be drained and also to identify healthy and necessary lymphatic pathways. These pathways and lymph nodes are used to change the path of protein-rich lymph fluid from the organ or the swollen part of the body to the venous system. The basis of the technique of manual lymph drainage is the basic strokes, which are: Rotary, pump, stationary circle, scoop. The common feature of all four techniques is having two phases, including the working or pressing phase and the rest or relaxing phase. All of these techniques are applied from the center to the periphery, in such a way that first the proximal areas are drained in order to prepare for the liquid collected in the distal parts. In the working phase of each stroke, the stimuli A stretch is applied to the subcutaneous tissue. The pressure in this phase should be so much that it causes the subcutaneous tissue to stretch on the underlying fascia to the extent of its elastic capacity. Applying gentle and directional pressure during the work phase causes the movement of lymph fluid in the right direction and causes the lymph to drain in the desired direction. The best result is achieved when each work phase lasts one second and 5 to 7 times at each point in a fixed pattern. Or a varied pattern is repeated.</i_keyword>
      <i_keyword>Intervention group: exercise: In this study, patients exercise for one session and for a duration of 30 minutes according to the therapeutic exercise protocol. The patients' exercise protocol includes diaphragmatic breathing, stretching exercises of the upper limbs, including stretching of the flexor and extensor muscles of the arm and wrist; The patient keeps each stretching exercise for 15-30 seconds and repeats two sets of three. While performing diaphragmatic breathing, the patient's position is such that the patient's fingers are placed in front of the sternum and the patient starts performing diaphragmatic breathing. When performing exercises, compression bandages or compression bandages should be used. Tight and restrictive clothes should not be used during exercise. Movements should be slow and controlled.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Organ volume: measuring the circumference of the limb with lymphedema. Timepoint: Before and after the intervention during the same session. Method of measurement: A standard tape measure tool was used to measure manual lymphatic drainage.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain: score from 1 to 10 based on VAS scale. Timepoint: Before and after the intervention during the same session. Method of measurement: The measurement was done with a tape measure.</sec_outcome>
      <sec_outcome>Quality of life: checking people's quality of life using the score of the quality of life questionnaire. Timepoint: Before and after the intervention during the same session. Method of measurement: By evaluating the score of the quality of life questionnaire of the World Health Organization.</sec_outcome>
      <sec_outcome>Shoulder range of motion: the degree of shoulder elevation angle. Timepoint: Before and after the intervention during the same session. Method of measurement: The movement angle of the shoulder is measured using a goniometer.</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>2024-05-06</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
