<?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>IRCT20241128063883N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-31</date_registration>
      <primary_sponsor>University Of Isfahan – Physical Education Department Of The University Of Isfahan</primary_sponsor>
      <public_title>reactive – core training  for Reducing Chronic Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of reactive – core training   on pain,  some functional characteristics and quality of life in male  with  non-specific  low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80460</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group performed a combined reactive–core stability exercise program for eight weeks, consisting of three sessions per week, each lasting approximately 60 minutes.Each session included three phases:1. Warm-up (10 min): Walking, dynamic and stretching exercises, followed by 5 minutes of moderate-intensity cycling on a stationary bike.2. Main exercises (40 min): The core program included reactive–core stability exercises such as abdominal vacuum on a ball, bridge with resistance band, bird-dog on a ball, isometric and balance exercises in unstable positions. Exercise intensity was progressively increased from week 1 to week 8 (holding time from 12 to 30 seconds). Swiss ball and elastic bands were used as auxiliary tools. Exercise load was adjusted based on each participant’s pain tolerance, and movements were modified if discomfort occurred.3. Cool-down (5 min): Light walking and gentle stretching to return the body to the initial state.All sessions were supervised by the researcher and assisted by a nurse. The training aimed to improve motor control, enhance core stability, and activate deep lumbar–pelvic muscles (multifidus and transversus abdominis). Intervention 2: Control Group: Participants in the control group engaged in a conventional core stability exercise program for eight weeks, with three sessions per week (each lasting approximately 60 minutes). Each session consisted of three parts:1. Warm-up (10 minutes): Light walking, general stretching exercises, and basic mobility drills to prepare the body for training.2. Main phase (40 minutes): Standard core stability exercises such as basic glute bridges, abdominal and lumbar strengthening routines performed in stable positions, and isometric holds without the use of unstable surfaces. Exercise intensity remained consistent throughout the program and followed standard rehabilitation protocols. No reactive or instability-based movements were included. Exercises were adjusted based on each participant’s pain tolerance.3. Cool-down (10 minutes): Gentle stretching and slow walking to return the body to its resting state.All sessions were supervised by the researcher and conducted in the presence of a nurse. The aim of this program was to maintain and enhance basic core function without incorporating reactive or instability-focused components.</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:
Effect of reactive – core training   on pain,  some functional characteristics and quality of life in patiant  with  non-specific  low back pain

When:
The data will become available after the publication of the article derived from this thesis and will remain accessible for at least five years for academic and research purposes.

To whom:
For all students of Physical Education, Physiotherapy, and Occupational Therapy

Conditions:
The data and documents may be used for academic and research purposes upon request and with proper citation. Use is permitted for students, educators, and researchers in fields related to physical education, physiotherapy, and rehabilitation. Commercial use or redistribution is not allowed without written permission from the principal investigator.

Where to obtain:
The data and documents will be obtainable from the principal investigator upon request, and after the publication of the article derived from this thesis. The study is affiliated with the University of Isfahan – Faculty of Physical Education and Sport Sciences.

How to obtain:
Interested researchers or academic users must submit a formal request to the principal investigator via email. The request should include the purpose of data use, institutional affiliation, and a commitment to proper citation. Access will be granted after the publication of the article derived from this thesis, and only for non-commercial academic or research purposes.

Comments:
This study is part of a doctoral thesis conducted at the University of Isfahan – Faculty of Physical Education and Sport Sciences. The data will be available after the publication of the derived article and may be used for academic purposes upon request. The intervention protocol is designed to benefit students in Physical Education, Physiotherapy, and Occupational Therapy.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Seyedazizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koye Ghasemzade.,Emam Ave</address>
        <city>Meshgin Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5661614513</zip>
        <telephone>+98 45 3215 1161</telephone>
        <email>vahid.seyedazizi@gmail.com</email>
        <affiliation>Isfehan Univercity</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Seyedazizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koye Ghasemzade.,Emam Ave</address>
        <city>Meshgin Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5661614513</zip>
        <telephone>+98 45 3215 1161</telephone>
        <email>Vahid.seyedazizi@gmail.com</email>
        <affiliation>University Of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having pain (2-5 based on the var scale)
The gender of men and women in the age range of 40-60
Chronic back pain for more than three months
The ability to do exercises (based on the opinion of a specialist doctor)
Voluntary participation in the study</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of spondylolisthesis
rheumatic inflammatory diseases
acute disc herniation
had any spinal surgery
irregular participation in training sessions (3 consecutive sessions - 5 alternating sessions)
failure to complete research tests
any unpredictable problems that hinder  The subject's presence in the training
withdrawal will be voluntary</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dorsalgia, unspecified</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: Participants in the intervention group performed a combined reactive–core stability exercise program for eight weeks, consisting of three sessions per week, each lasting approximately 60 minutes.Each session included three phases:1. Warm-up (10 min): Walking, dynamic and stretching exercises, followed by 5 minutes of moderate-intensity cycling on a stationary bike.2. Main exercises (40 min): The core program included reactive–core stability exercises such as abdominal vacuum on a ball, bridge with resistance band, bird-dog on a ball, isometric and balance exercises in unstable positions. Exercise intensity was progressively increased from week 1 to week 8 (holding time from 12 to 30 seconds). Swiss ball and elastic bands were used as auxiliary tools. Exercise load was adjusted based on each participant’s pain tolerance, and movements were modified if discomfort occurred.3. Cool-down (5 min): Light walking and gentle stretching to return the body to the initial state.All sessions were supervised by the researcher and assisted by a nurse. The training aimed to improve motor control, enhance core stability, and activate deep lumbar–pelvic muscles (multifidus and transversus abdominis).</i_keyword>
      <i_keyword>Control Group: Participants in the control group engaged in a conventional core stability exercise program for eight weeks, with three sessions per week (each lasting approximately 60 minutes). Each session consisted of three parts:1. Warm-up (10 minutes): Light walking, general stretching exercises, and basic mobility drills to prepare the body for training.2. Main phase (40 minutes): Standard core stability exercises such as basic glute bridges, abdominal and lumbar strengthening routines performed in stable positions, and isometric holds without the use of unstable surfaces. Exercise intensity remained consistent throughout the program and followed standard rehabilitation protocols. No reactive or instability-based movements were included. Exercises were adjusted based on each participant’s pain tolerance.3. Cool-down (10 minutes): Gentle stretching and slow walking to return the body to its resting state.All sessions were supervised by the researcher and conducted in the presence of a nurse. The aim of this program was to maintain and enhance basic core function without incorporating reactive or instability-focused components.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: Pain assessment with VAS scale, fear of movement assessment with Tempa scale, quality of life assessment with SF36 test, functional disability assessment with ODI index, strength assessment with digital dynamometer, endurance assessment with McGill test, back flexibility assessment with Schuber test, motor performance assessment  With Lomajuki test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gait Performance. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: With foot scan device.</sec_outcome>
      <sec_outcome>Pain intensity. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: Pain assessment with Vas scale.</sec_outcome>
      <sec_outcome>Fear of movement. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: fear of movement assessment with Tempa scale.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: quality of life assessment with SF36.</sec_outcome>
      <sec_outcome>Functional disability. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: functional disability assessment with ODI index.</sec_outcome>
      <sec_outcome>Core muscle strength. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: strength assessment with digital dynamometer.</sec_outcome>
      <sec_outcome>Muscular endurance. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: endurance assessment with McGill test.</sec_outcome>
      <sec_outcome>Lumbar flexibility. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: back flexibility assessment with Schuber test.</sec_outcome>
      <sec_outcome>Motor performance. Timepoint: Outcome variables will be measured at two timepoints:  &gt; 1. Baseline – prior to the start of the intervention  &gt; 2. Post-intervention – immediately after completing the 8-week reactive–core stability exercise program. Method of measurement: motor performance assessment  With Lomajuki test.</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 Isfahan – Physical Education Department Of The University Of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-07</approval_date>
        <contact_name>Ethics committee of Somewhere University of esfahan</contact_name>
        <contact_address>Emam Ave.koye ghasemzade Meshgin shahr Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
