<?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>IRCT20180727040609N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-01</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>Comparison of two methods of core stability exercises to improve chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of two isometric and isotonic core stability exercise methods on pain and performance in people with non-specific chronic back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69184</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: For the randomization process, each patient will choose a number in a sealed envelope. For the convenience of calculation, the website program "Research Randomizer" will be used. 
Therefore, these patients were equally divided into the following three groups: isometric stability training group (n=15), isotonic stability training group (n=15) and control group (n=15), Blinding description: In this study, after the subjects were referred to the exercise therapy department by the doctor, they will go through a complete treatment process and will not be informed that they are included in a research. 
On the other hand, in order to examine dependent variables before and after therapeutic exercise, we have considered experts who will be unaware of the research process. 
Therefore, our study will involve blinding of patients and assessors (double-blind).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Isometric core stability exercises. In this group, the training intervention only includes training movements that are performed in a static position with isometric contractions. Patients in this group will exercise for 8 weeks (three sessions, 45-60 minutes per week) under the direct supervision of a specialist, using equipment such as Swiss ball, Theraband and light weights. The number of movements is from 6 to 12 in each session, which will be progressed from the beginning to the end of the treatment based on the patient's level of adaptation. Intervention 2: Intervention group: Isotonic core stability exercises. In this group, the exercise intervention only includes exercise movements that are performed in a dynamic position with isotonic contractions (without maintaining a constant contraction). Patients in this group will exercise for 8 weeks (three sessions of 45-60 minutes per week) under the direct supervision of a specialist, using equipment such as Swiss ball, Theraband and light weights. The number of movements is from 6 to 12 in each session, which will be progressed from the beginning to the end of the treatment based on the patient's level of adaptation. Intervention 3: Control group: (no intervention). During the entire research period, the control group will be under simple supervision and will not receive any therapeutic 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:
All the above information will be made available in the format of university plan and research articles

When:
6 to 15 months after the completion of the research plan

To whom:
All researchers, therapists and specialists

Conditions:
In order to help therapists, researchers and specialists to promote academic research and treatment of patients

Where to obtain:
Dr. Arash Khaledi, contact number: 09120078615, email address: arashkhaledi@ut.ac.ir

How to obtain:
As soon as possible and after the publication of scientific articles, everything that can help the scientific and therapeutic process will be available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Khaledi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9718996488</zip>
        <telephone>021 883517300</telephone>
        <email>arashkhaledi666@gmail.com</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Gheitasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sport Sciences and Health Faculty, Shahid Beheshti (national) University, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2243 1953</telephone>
        <email>m_gheitasi@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with non-specific chronic back pain
Absence of any history of spine surgery
Absence of pathological records (disease) of the spine
Absence of orthopedic and neurological injuries
Absence of structural or functional shortness of more than 2 cm in one of the lower limbs</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of the lumbar disc herniation
The presence of the acute stage of lumbar disc protrusion
The presence of the systematic diseases (such as cardiovascular)
Spine surgery in the past
Having a fracture or inflammatory diseases of the spine
Having any therapeutic intervention in the last two months
Taking medical drugs
Failure to participate in the treatment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Isometric core stability exercises. In this group, the training intervention only includes training movements that are performed in a static position with isometric contractions. Patients in this group will exercise for 8 weeks (three sessions, 45-60 minutes per week) under the direct supervision of a specialist, using equipment such as Swiss ball, Theraband and light weights. The number of movements is from 6 to 12 in each session, which will be progressed from the beginning to the end of the treatment based on the patient's level of adaptation.</i_keyword>
      <i_keyword>Intervention group: Isotonic core stability exercises. In this group, the exercise intervention only includes exercise movements that are performed in a dynamic position with isotonic contractions (without maintaining a constant contraction). Patients in this group will exercise for 8 weeks (three sessions of 45-60 minutes per week) under the direct supervision of a specialist, using equipment such as Swiss ball, Theraband and light weights. The number of movements is from 6 to 12 in each session, which will be progressed from the beginning to the end of the treatment based on the patient's level of adaptation.</i_keyword>
      <i_keyword>Control group: (no intervention). During the entire research period, the control group will be under simple supervision and will not receive any therapeutic intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 8 weeks. The pain variable will be evaluated one day before the start and one day after the end of the research/treatment period. Method of measurement: Pain (Using Visual Analog Scale; VAS ).</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: 8 weeks. The functional disability variable will be evaluated one day before the start and one day after the end of the research/treatment period. Method of measurement: Functional disability (Using Oswestry questionnaire).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: 8 weeks. The pain variable will be evaluated one day before the start and one day after the end of the research/treatment period. Method of measurement: The visual analogue scale (VAS).</sec_outcome>
      <sec_outcome>Functional disability. Timepoint: En 8 weeks. The functional disability variable will be evaluated one day before the start and one day after the end of the research/treatment period. Method of measurement: Functional disability (Using Oswestry questionnaire).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Beheshti University</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University</source_name>
      <source_name>Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-08</approval_date>
        <contact_name>Ethics Committee at the Institute of Physical Education and Sports Science</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.  Research Institute of Physical Education and Sports Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
