<?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>IRCT20250104064273N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-30</date_registration>
      <primary_sponsor>Bu Ali Sina University</primary_sponsor>
      <public_title>Effect of Core exercises on postpartum low back pain and DRA</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of diastasis recti abdominis rehabilitation exercises on postpartum low back pain and inter-recti distance in affected women: A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87001</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Design of Comprehensive Exercises for Diastasis Recti, Randomization description: In this study, subjects will be randomized based on the Random Number Generator software and then assigned to dual groups based on allocation concealment using the SNOSE method. Participants will be randomly assigned to one of the rehabilitation exercise groups (n=20) or the control group (n=20), Blinding description: The assessors and study participants are blinded to the allocation and randomization of groups. Participants will be fully informed of the study’s purpose and inclusion rationale, while remaining blinded to group allocation to minimize bias and ensure methodological integrity.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Postpartum low back pain. Condition 2: Diastasis recti abdominis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 8 weeks of comprehensive rehabilitation exercises including core strengthening exercises from beginner to advanced. Intervention 2: Control group: No intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only data related to demographic information and outcomes will be shared.

When:
After publishing the article/articles extracted from the study

To whom:
The data can be displayed and shared upon reasonable request by the Iranian Clinical Trial Registry Center, journals, and individuals/academic researchers who are conducting research and scientific activities in this field.

Conditions:
Data analysis and use of documentation can only be done on the condition that their results are stated in systematic review articles conducted by researchers and academic authors. Conditions for registering the submission of data and documentation include: 1. Sending an email (preferably with valid academic addresses) to one of the study researchers. 2. A brief and logical explanation regarding how the data or documentation will be used. 3. Ensuring the registration of the protocol of systematic review studies that have given access to the data or documentation.

Where to obtain:
By requesting from the study researcher, Nahid Bigdeli, by email n.bigdeli@phe.basu.ac.ir

How to obtain:
The applicant can request details from the researchers using an email message within 7 to 10 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Bigdeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Ahmadi Roshan Blvd</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3869565178</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>n.bigdeli@phe.basu.ac.ir</email>
        <affiliation>Bu Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Bigdeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina university, Ahmadi Roshan Blvd</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3869565178</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>n.bigdeli@phe.basu.ac.ir</email>
        <affiliation>Bu Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with postpartum low back pain
Age range of 20-45
Having DRA above 2 cm in the 4.5 cm upper, below, and the umbilicus.
The vaginal delivery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cardiovascular diseases
Acute low back pain (e.g., spondylolisthesis, herniation, etc.)
Rheumatic diseases of the spine
CNS and PNS diseases (Parkinson, MS, etc.)
Abdominal herniation
low back surgery
Gestational diabetes
Doing sports activities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 8 weeks of comprehensive rehabilitation exercises including core strengthening exercises from beginner to advanced.</i_keyword>
      <i_keyword>Control group: No intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum low back pain. Timepoint: Pre- and Post-test of 8 weeks intervention. Method of measurement: VAS scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</sec_outcome>
      <sec_outcome>Diastasis recti abdominis. Timepoint: pre- and post-intervention. Method of measurement: Ultrasonography.</sec_outcome>
      <sec_outcome>Thickness of core muscles. Timepoint: pre- and post-intervention. Method of measurement: Ultrasonography.</sec_outcome>
      <sec_outcome>Brain activity patterns. Timepoint: pre- and post-intervention. Method of measurement: EEG.</sec_outcome>
      <sec_outcome>Core muscle activity patterns. Timepoint: pre- and post-intervention. Method of measurement: EMG.</sec_outcome>
      <sec_outcome>Functional disability. Timepoint: pre- and post-intervention. Method of measurement: Oswestry Questionnaire.</sec_outcome>
      <sec_outcome>Lumbopelvic proprioception. Timepoint: pre- and post-intervention. Method of measurement: Goniameter.</sec_outcome>
      <sec_outcome>Lumbopelvic motor control. Timepoint: pre- and post-intervention. Method of measurement: pressure biofeedback.</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>Bu Ali Sina University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-05</approval_date>
        <contact_name>Research Ethics committee of Bu Ali Sina University-Hamedan</contact_name>
        <contact_address>Ahmadi Roshan Blvd., Bu Ali Sina University Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
