<?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>IRCT20200107046035N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-02</date_registration>
      <primary_sponsor>Shafagh University</primary_sponsor>
      <public_title>The Effect of Exercises in Women with Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Core Stability Exercises on Lumbopelvic Motor Control, Dynamic Balance, Pain and Disability in Women with Non-specific Chronic Low Back Pain and Follow up one Month After Stopping Training</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51831</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple Randomization Method was used to Assign Individuals to two Groups that in this Method It was done by Flip the coin method. This method is usually used to create a random sequence in two-group experiments in such a way that one of the study groups considers the A and the other group the B and based on the sample size, coins were tossed and Individuals are assigned to two random groups. Then, in Order not to Determine Which Group the Individuals will be Assigned to before Dividing them into two Groups, or in other words, Allocation Concealment, the Sequentially numbered, sealed opaque envelopes was used. This method is one of the common methods in concealing random allocation, which is abbreviated to SNOSE method. In this method, after a random sequence, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific Chronic Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Core Stability Training that Strengthens the Stabilizer muscles of body center for 6 weeks, 3 Sessions per Week, 2 Hour per Session. Core stability exercises are specific exercises that stabilize the spine, which retrains the deep sense of the pelvic lumbar region in different positions (arch, back, squat) and also adds dynamic components to it (movement of limbs, use of Swiss ball) in the next steps. Is. The Core stability exercises suggested by Jeffrey include five levels. Exercises start from level one, which includes static contractions in a fixed position, level two exercises, including holding static contractions and slow movements in a stable environment, level three, including holding static contractions in an unstable environment, and dynamic movements in a fixed environment. Level four includes dynamic movements in an unstable environment, and finally level five exercises include dynamic and resistance movements in an unstable environment. In these exercises, Swiss balls are used. Intervention 2: Control group: Without any Training and Treatment that just Doing Normal 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:
All potential data can be shared after people have not been identified

When:
Start the access period one year after printing the results

To whom:
Data will be available to academic and scientific researchers

Conditions:
Any kind of functional analysis on the submitted data is allowed

Where to obtain:
by Email: h.shahrokhi@hsu.ac.ir

How to obtain:
by Email: h.shahrokhi@hsu.ac.ir and the reason for using the documents

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Shahrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Shahr, Sabzevar, Iran</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 51 4401 2756</telephone>
        <email>h.shahrokhi@hsu.ac.ir</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Shahrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Shahr, Sabzevar, Iran</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 51 4401 2756</telephone>
        <email>h.shahrokhi@hsu.ac.ir</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-specific Chronic Low Back Pain
Age range 30 to 50 years
Ostwestry Disability Index equal to or greater than 15
Female gender</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Vestibular Disorders
Perform Lumbopelvic Surgery</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>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Core Stability Training that Strengthens the Stabilizer muscles of body center for 6 weeks, 3 Sessions per Week, 2 Hour per Session. Core stability exercises are specific exercises that stabilize the spine, which retrains the deep sense of the pelvic lumbar region in different positions (arch, back, squat) and also adds dynamic components to it (movement of limbs, use of Swiss ball) in the next steps. Is. The Core stability exercises suggested by Jeffrey include five levels. Exercises start from level one, which includes static contractions in a fixed position, level two exercises, including holding static contractions and slow movements in a stable environment, level three, including holding static contractions in an unstable environment, and dynamic movements in a fixed environment. Level four includes dynamic movements in an unstable environment, and finally level five exercises include dynamic and resistance movements in an unstable environment. In these exercises, Swiss balls are used.</i_keyword>
      <i_keyword>Control group: Without any Training and Treatment that just Doing Normal Daily Activities</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lumbopelvic Motor Control. Timepoint: At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training. Method of measurement: five tests (the bent knee fall out test, the knee lift abdominal test, the sitting knee extension test, the waiter bow and the transversus abdominis test).</prim_outcome>
      <prim_outcome>Dynamic Balance. Timepoint: At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training. Method of measurement: Biodex Balance System.</prim_outcome>
      <prim_outcome>Pain. Timepoint: At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training. Method of measurement: Ostwestry Disability Index.</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>Shafagh University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-16</approval_date>
        <contact_name>Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
