<?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>IRCT20181007041265N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-24</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Stabilization exercises in improvement of lumbopelvic pain in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of core stabilization exercises focusing on pelvic floor and deep abdominal muscles on pain, functional disability and quality of life in pregnant women with lumbopelvic pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34321</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization
Sealed envelopes, Blinding description: Participants will be unaware of the existence of the two groups and which group they are in.
An individual has the responsibility to evaluate patients in three stages as well as which group of patients will be unaware of.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbopelvic pains.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study was conducted for 10 weeks and 3 sessions per week in the training group, one session grouped under the supervision of a physiotherapist. Since it's difficult to attend training sessions at all sessions, doing 2 sessions of weekly exercises is done by giving a visual instruction to a person at home. Each group therapy session lasted for 60 minutes, including 10 minutes of general warm-up (walking), 40 minutes of stability training, focusing on abdominal muscles and pelvic floor, and 10 minutes of cooling training (including breathing and relaxation exercises).The exercises at home are similar to the same group exercises and are performed at least twice a week for 30 minutes. In the training group, the exercise is performed in three stages, such that the first phase consists of four sessions, which in 2 sessions First, on the isometric contraction and the isolation of the abdominal muscles and pelvic floor muscles in various positions, such as four hands and feet, supine, sitting and standing, and in the next 2 sessions, exercises were made by concurrent abdominal muscles and pelvic floor muscles in the position The above mentioned is done. The second stage, if properly performed, will begin muscle contraction, so that 3 sessions, while maintaining abdominal contraction and pelvic floor, will be loaded quantitatively by the controlled movements of the limbs in different positions. In the third phase, during 3 sessions, this is also a contraction of the muscles, with functional postures and activities that have already exacerbated the symptoms of the patient. At this stage, the patient is encouraged to activate these muscles regularly during daily activities. It should be noted that during each treatment session, each of the exercises will be performed in 10set 10 second. Intervention 2: Control group: The control group received only the usual care and education from the doctor or midwife, but they are not prohibited from exercising themselves.</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>Hosein Negahban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakilabad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185763788</zip>
        <telephone>+98 51 3882 7029</telephone>
        <email>negahbanh@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Negahban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakilabad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185763788</zip>
        <telephone>+98 51 3882 7029</telephone>
        <email>negahbanh@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 years and older
First pregnancy
Week 14-18  of pregnancy
Lumbopelvic pain more than 1 week</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Abortion history
High-risk pregnancy
Medicinal Therapies during pregnancy
Lumbopelvic pain history before pregnancy
Contra indication of exercise during pregnancy to diagnose of doctor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>026</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal care for other conditions predominantly related to pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study was conducted for 10 weeks and 3 sessions per week in the training group, one session grouped under the supervision of a physiotherapist. Since it's difficult to attend training sessions at all sessions, doing 2 sessions of weekly exercises is done by giving a visual instruction to a person at home. Each group therapy session lasted for 60 minutes, including 10 minutes of general warm-up (walking), 40 minutes of stability training, focusing on abdominal muscles and pelvic floor, and 10 minutes of cooling training (including breathing and relaxation exercises).The exercises at home are similar to the same group exercises and are performed at least twice a week for 30 minutes. In the training group, the exercise is performed in three stages, such that the first phase consists of four sessions, which in 2 sessions First, on the isometric contraction and the isolation of the abdominal muscles and pelvic floor muscles in various positions, such as four hands and feet, supine, sitting and standing, and in the next 2 sessions, exercises were made by concurrent abdominal muscles and pelvic floor muscles in the position The above mentioned is done. The second stage, if properly performed, will begin muscle contraction, so that 3 sessions, while maintaining abdominal contraction and pelvic floor, will be loaded quantitatively by the controlled movements of the limbs in different positions. In the third phase, during 3 sessions, this is also a contraction of the muscles, with functional postures and activities that have already exacerbated the symptoms of the patient. At this stage, the patient is encouraged to activate these muscles regularly during daily activities. It should be noted that during each treatment session, each of the exercises will be performed in 10set 10 second</i_keyword>
      <i_keyword>Control group: The control group received only the usual care and education from the doctor or midwife, but they are not prohibited from exercising themselves.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Before the start of the treatment, immediately after the completion of the program, the last week of pregnancy and 6 weeks after delivery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before the start of the treatment, immediately after the completion of the program, the last week of pregnancy and 6 weeks after delivery. Method of measurement: Oswestry disability index questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the start of the treatment, immediately after the completion of the program, the last week of pregnancy and 6 weeks after delivery. Method of measurement: The World Health Organization Quality of Life Questionnaire (WHOQOL-BREF).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-07</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vakilabad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
