<?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>IRCT20250915067250N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-25</date_registration>
      <primary_sponsor>Tehran University of Physical education and science</primary_sponsor>
      <public_title>"Investigating the effect of balance, lumbar stability, and combined exercise protocols on improving motor function, core muscle strength, postural instability, and quality of life in men with chronic nonspecific low back pain"</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of balance, lumbar stability, and combined exercise protocols on improving motor function, core muscle strength, postural instability, and quality of life in men with chronic nonspecific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86408</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple Randomization was used, each participant is randomly assigned to one of the groups. And it is done using a lottery. Its unit is the choice (individual).
It is done using the statistical software spss with analysis of covariance.
The groups participating in the research each attend the clinic at a separate time so that each group's exercises remain hidden, Blinding description: All research participants are blinded and do not know about their treatment exercises, but all research steps are fully explained to them. Only the relevant doctor and the examiners know about the process and type of exercises. Therefore, the study is single-blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low back pain chronic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: "Balance exercises for eight weeks, three sessions per week, 3 sets, 15 repetitions per set.". Intervention 2: Intervention group 2: "Stability exercises for eight weeks, three sessions per week, 3 sets, 15 repetitions per set.". Intervention 3: Intervention group 3: "Combined exercises that include balance and stability exercises, which are eight weeks, three sessions per week, 3 sets, and 15 repetitions per set.". Intervention 4: Control group: "They do not do any exercise activities and just do their daily tasks.".</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:
All data is potentially shareable after de-identifying individuals.

When:
Access period starts 5 months after results are published.

To whom:
It will be available to researchers working in academic and scientific institutions and students.

Conditions:
Data access is limited only to the participants themselves and they cannot learn about each other's information.

Where to obtain:
Please contact Mr. Amirhossein Rafiei at 09356792816 and address: Faculty of Sport Sciences, University of Tehran.

How to obtain:
After the request letter, each participant is required to submit a report within one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir hosein rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North kargar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 935 679 2816</telephone>
        <email>Amirhosein.rafie@ut.ac.ir</email>
        <affiliation>Tehran University of Physical education and science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hooman Minoonejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۷۹۳۵۸۴۰</zip>
        <telephone>+98 912 348 7425</telephone>
        <email>h.minoonejad@ut.ac.ir</email>
        <affiliation>Tehran University of Physical education and science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men with chronic non-specific low back pain with a history of at least three months
Getting a score above 2 on the Visual Analogue Scale (VAS) for measuring pain intensity
Having two deficits in performing a diagnostic test for movement control disorder</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Back pain in people under 18 years of age
Having surgery within 1 month</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>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: "Balance exercises for eight weeks, three sessions per week, 3 sets, 15 repetitions per set."</i_keyword>
      <i_keyword>Intervention group 2: "Stability exercises for eight weeks, three sessions per week, 3 sets, 15 repetitions per set."</i_keyword>
      <i_keyword>Intervention group 3: "Combined exercises that include balance and stability exercises, which are eight weeks, three sessions per week, 3 sets, and 15 repetitions per set."</i_keyword>
      <i_keyword>Control group: "They do not do any exercise activities and just do their daily tasks."</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual analogue scale. Timepoint: 8 weeks. Method of measurement: To measure pain, a visual analog scale (VAS) was used. This scale was drawn and graded as a 10-cm line, which was used to measure the intensity of perceived pain in this study.</prim_outcome>
      <prim_outcome>Roland Morris Questionnaire. Timepoint: 8 Weeks. Method of measurement: The standard Roland Morris questionnaire is used to measure the level of disability. This questionnaire consists of 24 questions, each question has one point. Subjects who score less than 4 are excluded from the study.</prim_outcome>
      <prim_outcome>Quality of life questionnaire. Timepoint: 8 weeks. Method of measurement: The SF-36 Quality of Life Questionnaire is a self-report questionnaire that is mainly used to assess quality of life and health. This scale consists of 36 items divided into 8 subscales: physical functioning, role limitation due to problems, physical pain, physical general health, role limitation due to emotional problems, social functioning, vitality, and emotional well-being.</prim_outcome>
      <prim_outcome>Measuring postural oscillation. Timepoint: 8 weeks. Method of measurement: The subject's postural fluctuation is measured by a plantar pressure distribution device. The distance of the body's center of pressure fluctuation in millimeters and the area of ​​the body's center of pressure fluctuation range in square millimeters are displayed on the computer screen and recorded as indicators of the amount of postural fluctuation for each subject.</prim_outcome>
      <prim_outcome>Measuring core muscle endurance. Timepoint: 8 weeks. Method of measurement: The McGill test is used to measure core muscle endurance. This test is performed in 4 positions, including the anterior trunk flexor test, right and left lateral plank, and trunk extensor test. The subjects practiced each position once to learn the correct movement and for a maximum of 5 seconds to prevent fatigue, and then for the main test, they were asked to maintain each position for as long as possible. The longest time that the subjects were able to maintain the correct position was recorded.</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>Tehran University of Sport Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-19</approval_date>
        <contact_name>Ethics committee of Tehran University of sport Sciences</contact_name>
        <contact_address>No. 64, West Ashrafi Ave, Vali Asr Street. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
