<?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>IRCT20200713048096N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-12</date_registration>
      <primary_sponsor>The University of Tarbiat modare</primary_sponsor>
      <public_title>The effect of  Buerger Allen exercise on  lower extremities edema during late pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Modified Buerger Allen exercise on peripheral lower extremities edema during late pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49645</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: ple in the community from 1. This numbering will be done without observing any special order.
Step 2: We will randomly select a number as the sampling source in the table of random numbers.
Step 3: From the origin of nuns, we will consider rows with the number of nuns digits.
Step 4: We will read the numbers of the selected rows in order. We will count each repeated number only once.
The first selected number will be in the intervention group and the next number will be in the control group.
Sampling will continue until the sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Physiological edema of the lower extremities in late pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention groups include a group that will perform Burger Allen exercises at home for 10 days after training. How to do the exercises is as follows: 1- In the flat position, lean to the left (LLT) with an angle of 30-45 degrees so that it is supported by protection and raise the legs at an angle of 45 to 90 degrees, Raise your legs on a chair or board for 1.5 to 3 minutes.2. Then sit down and hang your legs for 3 to 5 minutes to restore their color. Care will be taken not to put pressure on the knees. In fact, each leg should be bent and stretched and then placed in this position for 3 minutes. The legs should be completely pink. If the legs are blue or painful, lift them up and rest if necessary. 3. Then for 3 minutes horizontally at a 180 degree angle and quietly in a relaxed position in a flat to the left. Lie down (LLT) at an angle of 30-45 degrees and keep your feet warm with a blanket. Intervention 2: Control group: The control group will receive routine prenatal care.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shadab Shahali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</zip>
        <telephone>+98 21 8828 1183</telephone>
        <email>shadab.shahali@modares.ac.ir</email>
        <affiliation>Trabiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shadab Shahali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</zip>
        <telephone>+98 21 8828 1183</telephone>
        <email>Shadab.Shahali@modares.ac.ir</email>
        <affiliation>Tarbiat modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First and singleton pregnancies
Age between 18 and 35
Normal pregnancy between 30 and 40 weeks
Edam in the legs and feet up to 2 plus
BMI in the normal range(Body mass index before pregnancy or in the first 6 weeks of pregnancy, can be adapted from the case of pregnant women and normal BMI 19.8 to 24 kg / m2)
Normal weight gain during pregnancy according to the weight growth chart in the file
Normal state of Amniotic Fluid and fetus
No history of infertility
Not suffering from any systemic disease such as heart, lung, diabetes, Thrombophlebitis and hypertension, skin diseases such as severe eczema
Lack of absolute rest
Absence of Preeclampsia and Eclampsia(according to the case)
No psychological problems (according to the case)
Not taking medication except pregnancy supplements(according to the case)
No drug addiction(according to the case)
The pain should be limited to the sole of the foot and ankle and not spread to other organs (according to the person)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Perform other exercises or other specific treatment to relieve foot edema during the study
Reluctance to do exercises
Premature delivery or any termination of pregnancy during the intervention
Standing for a long time or having working conditions Sitting and standing for a long time
Problems such as lower limb fractures
Receive medication or a special diet to relieve pain and edema while studying
Suffering from Preeclampsia in the intervention process
Receive other methods of complementary medicine
Reluctance to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O12.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational edema</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: Intervention groups include a group that will perform Burger Allen exercises at home for 10 days after training. How to do the exercises is as follows: 1- In the flat position, lean to the left (LLT) with an angle of 30-45 degrees so that it is supported by protection and raise the legs at an angle of 45 to 90 degrees, Raise your legs on a chair or board for 1.5 to 3 minutes.2. Then sit down and hang your legs for 3 to 5 minutes to restore their color. Care will be taken not to put pressure on the knees. In fact, each leg should be bent and stretched and then placed in this position for 3 minutes. The legs should be completely pink. If the legs are blue or painful, lift them up and rest if necessary. 3. Then for 3 minutes horizontally at a 180 degree angle and quietly in a relaxed position in a flat to the left. Lie down (LLT) at an angle of 30-45 degrees and keep your feet warm with a blanket</i_keyword>
      <i_keyword>Control group: The control group will receive routine prenatal care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of pregnant women with lower extremity physiological edema. Timepoint: Measurement of leg edema at the beginning of the study and 5 and 10 days after the start of the intervention. Method of measurement: Measurement of ankle circumference, heel circumference and joint circumference between toes and metatarsal bone by tape measure and foot volume with volumeter.</prim_outcome>
      <prim_outcome>Pain in the lower leg. Timepoint: Measurement of lower limb pain at the beginning of the study and 5 and 10 days after the start of the intervention. Method of measurement: Using a ten-point numerical scale(visual Analogue Scale) of pain and asking questions from the research unit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Diet. Timepoint: Before and 5 and 10 days after the intervention. Method of measurement: Use of food frequency questionnaire.</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>The University of Tarbiat modare</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-02</approval_date>
        <contact_name>ethic committee of tarbiat modares university</contact_name>
        <contact_address>Tehran - Jalal Al-Ahmad Highway ,Nasr Bridge tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
