<?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>IRCT20250219064774N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-03</date_registration>
      <primary_sponsor>University of Sistan and Baluchestan</primary_sponsor>
      <public_title>The effect of breathing exercises and center stability exercises in pre-elderly women with non-specific chronic back pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding breathing exercises to core stability exercises on pain, function, balance and fear of movement in pre-elderly women with non-specific chronic back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82112</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Through a lottery and in the presence of the individuals themselves, each person will be given a number from 1 to 30. The numbers are written on paper and the papers are folded and placed in a container (container number 1). Then in another container, the names of the groups (each group has 15 sheets) are folded and placed in the container (container number 2). Then a lottery will be held in the presence of the participants. One person will draw the lottery number and group and one person will record and write the lottery numbers (one sheet will be taken from container number 1, one sheet from container number 2. For example, number 10 is the control group, number 13 is the training group, etc.) All individuals will be grouped in the same way, Blinding description: In this study, outcome assessors (laboratory technicians) are asked to take the desired tests from the patients. These individuals will be unaware of the purpose of the study, the assignment to study groups, and the reason for their presence in the laboratory, and will only assess the variables and record their observations.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic nonspecific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Breathing exercises and core stability exercises for improving low back pain. The exercises will be performed three sessions per week for 8 weeks. Intervention 2: Stability exercises at the center. The exercises will be three sessions per week for 8 weeks.</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 available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Kashefi Nezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816745845</zip>
        <telephone>+98 914 032 4665</telephone>
        <email>zahrakashefi4665@gmail.com</email>
        <affiliation>University of Sistan and Baluchestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Kashefi Nezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816745845</zip>
        <telephone>+98 914 032 4665</telephone>
        <email>zahrakashefi4665@gmail.com</email>
        <affiliation>University of Sistan and Baluchestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reports of pain in the lower back, lumbosacral region, and buttocks that is worse after physical activity
Age range 48 to 58 years
Back pain for more than 3 months
Full knowledge of aspects related to the study and possible benefits and losses and signing the informed consent form.</inclusion_criteria>
      <agemin>48 years</agemin>
      <agemax>58 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participation in regular physical activity in the past 6 months
Received non-specific chronic back pain treatment in the last month
Lumbar disc protrusion or fracture that leads to back pain
Osteoporosis or cancer or cardiorespiratory diseases and diabetes
Any surgery in the abdomen or chest, back pain following trauma, smoking, any breathing problems, having accompanying structural changes in the back tissues.
pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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:Breathing exercises and core stability exercises for improving low back pain. The exercises will be performed three sessions per week for 8 weeks.</i_keyword>
      <i_keyword>Stability exercises at the center. The exercises will be three sessions per week for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain level. Timepoint: Before the intervention, one day after the intervention. Method of measurement: Visual Pain Scale.</prim_outcome>
      <prim_outcome>Assessment of functional limitations. Timepoint: Before the intervention, one day after the intervention. Method of measurement: Roland Morris Disability Questionnaire and Oswestry Disability Index.</prim_outcome>
      <prim_outcome>Balance. Timepoint: Before the intervention, one day after the intervention. Method of measurement: 5 times standing and sitting test. Static balance: One-legged standing test with eyes closed. Dynamic balance: Through Y test.</prim_outcome>
      <prim_outcome>Fear of movement. Timepoint: Before the intervention, one day after the intervention. Method of measurement: Fear of movement questionnaire.</prim_outcome>
      <prim_outcome>Endurance. Timepoint: Before the intervention, one day after the intervention. Method of measurement: Sorensen test, Trunk flexor test.</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>University of Sistan and Baluchestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-09</approval_date>
        <contact_name>Research Ethics Committee of the University of Sistan and Baluchestan</contact_name>
        <contact_address>University Boulevard Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
