<?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>IRCT20220720055508N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-16</date_registration>
      <primary_sponsor>Shahid Behrshti University</primary_sponsor>
      <public_title>The effect of two different exercise programs on the improvement of back pain in female athletes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of dynamic neuromuscular stabilization and Barreausol exercises on the pain, functional disability, muscle endurance and mobility of athletes female with nonspecific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64909</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of grouping people is using the random block method. Participants are divided to three groups of 15 people: the first group received dynamic neuromuscular stability exercises, the second group received Barreausol exercises, and the third group, which is the control group, will not do any activity, Blinding description: All the participants in this research did not have any knowledge about the way of grouping, receival of training programs, and the research process and they were placed in groups A, B, and C.
And no information about the aforementioned groups has been provided to the data analyzer and statistician.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: dynamic neuromuscular stability exercises. During six weeks, the participants receive selected exercises three days a week for one hour. All exercises are presented from simple to advanced. The exercise program includes three parts: warm up, The main exercises are cooling down. These exercises start with low intensity and increase their intensity in the final sessions. The overload principle of gradual increase in each training session is controlled according to the correct implementation and training pressure in the previous session. Intervention 2: second intervention group, barreausol exercise: during six weeks, the participants receive selected exercises three days a week for one hour, all exercises are presented from simple to advanced. the training program includes three sections: warm-up, main and cool down exercises. Training starts from a few exercises and is gradually added to. The repetition of movements at the end of the session is increased compared to the previous session. Intervention 3: Control group:This group will not receive any activity during the research.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Adhami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 10, Number 4, Abolfazl Alley, Shahid Royan St, Sixteen meter second street,Western Veterans Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۳۹۶۹۴۱۱</zip>
        <telephone>+98 913 064 8828</telephone>
        <email>f.adhami@mail.sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Adhami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Student Blvd, Shahid Shahriari Square, Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۳۹۶۹۴۱۱</zip>
        <telephone>+98 913 064 8828</telephone>
        <email>fatemehadhami8828@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female gender
Age range from 20 to 40 years
Having chronic back pain during the last six months
Not having heavy sports training during the research
Being an athlete
Not taking medicines
No special diet
Normal body mass index
Absence of orthopedic and neurological diseases
Absence of surgery on spine and pelvis
Not having a rheumatic disease
Having a normal curvature of the lumbar angle (20-45)
Not having problems related to the sciatic nerve</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Willingness to withdraw at any time from the implementation of the training program or before and after the test
Being absent for more than two continuous sessions or more than three non-continuous sessions during the implementation of training programs
Injury during the implementation of the research period
Implementation of other rehabilitation programs during the research</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: dynamic neuromuscular stability exercises. During six weeks, the participants receive selected exercises three days a week for one hour. All exercises are presented from simple to advanced. The exercise program includes three parts: warm up, The main exercises are cooling down. These exercises start with low intensity and increase their intensity in the final sessions. The overload principle of gradual increase in each training session is controlled according to the correct implementation and training pressure in the previous session.</i_keyword>
      <i_keyword>second intervention group, barreausol exercise: during six weeks, the participants receive selected exercises three days a week for one hour, all exercises are presented from simple to advanced. the training program includes three sections: warm-up, main and cool down exercises. Training starts from a few exercises and is gradually added to. The repetition of movements at the end of the session is increased compared to the previous session.</i_keyword>
      <i_keyword>Control group:This group will not receive any activity during the research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre-test and post-test. Method of measurement: measurement of pain using Visual Analogue Scale ruler.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Pre-test and post-test. Method of measurement: Oswestry Disability Questionnaire.</prim_outcome>
      <prim_outcome>Muscle Endurance. Timepoint: Pre-test and post-test. Method of measurement: Beiring Sorensen test.</prim_outcome>
      <prim_outcome>Mobility. Timepoint: Pre-test and post-test. Method of measurement: (MMST)test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reducing social and economic damage caused by reducing the presence of a person in society. Timepoint: Six weeks after the intervention. Method of measurement: Analysis of statistics and information.</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>Shahid Behrshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-25</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University</contact_name>
        <contact_address>Shahid Beheshti University, Student Blvd, Shahid Shahriari Square, Evin, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
