<?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>IRCT20250208064684N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-01</date_registration>
      <primary_sponsor>university of tehran</primary_sponsor>
      <public_title>Effect and Persistence Durability of Selected Functional Restoration Exercise and Pilates on Pain, Functional Disability, Proprioception and Quality Of Life In Female with Non-S Pecific Chronic Low Back Pain.</public_title>
      <acronym></acronym>
      <scientific_title>Effect and Persistence Durability of Selected Functional Restoration Exercise and Pilates on Pain, Functional Disability, Proprioception and Quality Of Life In Female with Non-S Pecific Chronic Low Back Pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83768</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Fifty-four women were selected purposively and conveniently with the approval of an orthopedic specialist based on the inclusion criteria and were placed in three groups and randomly and equally divided into two intervention groups and a control group. In order to randomly assign the subjects to the intervention and control groups, a number was assigned to each subject, and the numbers were randomly divided between the three groups using a random number table. In order to conceal the numbers in each group, they were written on paper, and each was kept in a separate opaque sealed envelope. Each subject was asked to choose one of the envelopes and was placed in one of the groups based on the number, Blinding description: A blind strainIn order not to influence the test method and results, the experimenter was kept blind to which group (intervention or control) the subjects were in, and the subjects also expressed their consent to participate in a study by being fully informed about the research and filling out a consent form.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-SPecific Chronic Low Back Pain..</hc_freetext>
      <i_freetext>Intervention group: The intervention group did Pilates exercises and functional rehabilitation for 8 weeks, 3 sessions per week and each session lasted 45 to 60 minutes. Pilates - functional rehabilitation - controlThe control did not have any activity during this period and were engaged in daily activities.</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:
Pre- and post-tests and durability

When:
1405

To whom:
Researchers and workers and other people

Conditions:
Use for rehabilitation

Where to obtain:
Research team maral.am28@gmail.com

How to obtain:
email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mohammad hosein alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>university of tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>37 - 88351730</zip>
        <telephone>+98 912 348 9807</telephone>
        <email>alizadehm@ut.ac.ir</email>
        <affiliation>university of tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohammad hosein alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Northern Kargar St. - above Jalal Al Ahmad Intersection - between 15th and 16th Streets - in front of Koi University of Teh</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>37 - 88351730</zip>
        <telephone>+98 21 8835 1730</telephone>
        <email>alizadehm@ut.ac.ir</email>
        <affiliation>university of tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender (female) Participants participated in this study by signing a consent form and being aware of the research objectives and methods. Individuals suffering from chronic non-specific low back pain, body mass index between 18 and 25, women with an age range of 40-50 years, not having any regular exercise (at least two days a week) within the last 3 months before starting the protocol (3) History of low back pain for at least 12 weeks to diagnose chronicity of the disease</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- History of spinal surgery 2- Disc 3- Osteoporosis 4- Autoimmune disorders 5- Pregnancy 6- Fracture 7- Diabetes 8- Suffering from inflammatory spinal disease 9- People with any postural abnormalities 10- Absence of 3 sessions in training sessions (experimental group) 11- Participants' unwillingness to continue their activities at any stage of the research and voluntary withdrawal from participation and cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>M54.5 Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group did Pilates exercises and functional rehabilitation for 8 weeks, 3 sessions per week and each session lasted 45 to 60 minutes. Pilates - functional rehabilitation - controlThe control did not have any activity during this period and were engaged in daily activities</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of Pilates exercises and functional rehabilitation on pain, functional disability, range of motion, proprioception, and endurance in patients with non-specific chronic back pain. Timepoint: Before the intervention, 2 days after the completion of eight weeks, then a shelf life of 1 month. Method of measurement: Goniometer - Schuber test meter - Lumbar extension test - Measuring proprioception with goniometer - Abdominal test - McGill test - Visual pain scale - Quality of life questionnaire and functional disability questionnaire Asustri Bering Sorensen test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pilates- functional restoratoin. Timepoint: 2 months. Method of measurement: pilates- functional restoratoin.</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 tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-10</approval_date>
        <contact_name>کمیته اخلاق درپژوهش دانشکده علوم  ورزشی</contact_name>
        <contact_address>west tehran univercity of tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
