<?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>IRCT20200817048433N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-05</date_registration>
      <primary_sponsor>University of Tehran</primary_sponsor>
      <public_title>Comparison of the effect and the durability of exercise therapy on pain, movement control , functional and lower extremity flexibility in men with lumbar movement control dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect and the durability of Lumbar Stabilization exercises and Global Postural Re-education exercises on pain, movement control , functional and lower extremity flexibility in men with lumbar movement control dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54039</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the subjects are purposefully selected based on the inclusion and exclusion criteria of the research. The selected samples are then randomly divided into three groups (two training groups - control group). Randomization software (The Hat) is used for randomization. In this case, a code is assigned to each sample in the software, then as a random selection from the intervention and control groups, the intervention groups of the first choices come out and the control group is obtained from the next selection in the software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar movement control dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Global Postural Re-education exercises . This method included 8 treatment postures of lying, sitting, and standing which in the present study, five items of supine lying with abducted hands and open thighs angel, supine lying with abducted hands and closed of thighs angle, sitting with adducted hands and closed thighs angle, standing and bending the trunk forward, and standing against the wall and opening the angle of thighs are performed. The duration of each item varies from 5 to 15 minutes. These exercises are done for 6 weeks and three sessions per week. Intervention 2: Intervention group: Lumbar Stabilization exercises- LSEs are used to create segmental stability as well as improving movement control with qualifying and quantifying of movements. Exercises are performed by the subjects under the direct supervision of the examiner. The approximate time of each exercising session is between 40 and 50 minutes. These exercises are in 6 weeks of 3 sessions. There should be a 48-hour interval between exercising sessions. Exercises included 1.Curl-ups, 2.Dead bug, 3.Bird dog 4.Seated hip flexion, 5.Heel slides , 6.Bridge, 7.Sidebridge, 8.Standing theraband exercises. Intervention 3: Control group: The control group do not perform any specific exercise activities which affect the research results.</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:
Data on pain , muscle flexibility, movement control and lower  extremity function

When:
2021 year

To whom:
researchers

Conditions:
Comparison of their own research data with the data of this research

Where to obtain:
Corresponding Author

How to obtain:
Provide personal information, have a valid email address and appropriate explanations to receive information

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hooman Minoonejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirabad, Faculty of Physical Education and Sport Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417935840</zip>
        <telephone>+98 21 6111 8821</telephone>
        <email>h.minoonejad@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hooman Minoonejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۷۹۳۵۸۴۰</zip>
        <telephone>+98 21 6111 8821</telephone>
        <email>h.minoonejad@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants should have chronic nonspecific low back pain with movement control dysfunction.
Being classifiedas medium-risk subgroup (Pain range (6 - 3) on the Visual Analoge Scale)
Men aged 30 to 40 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Samples show pathological symptoms, history of fractures, tumors, surgery or joint diseases of the spine, pelvis and lower limbs.
having functional or congenital kyphosis and lordosis (higher than 42 and 52 degrees measured by flexible ruler)
having scoliosis (rotation above 5 degrees by scoliometer)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention group: Global Postural Re-education exercises . This method included 8 treatment postures of lying, sitting, and standing which in the present study, five items of supine lying with abducted hands and open thighs angel, supine lying with abducted hands and closed of thighs angle, sitting with adducted hands and closed thighs angle, standing and bending the trunk forward, and standing against the wall and opening the angle of thighs are performed. The duration of each item varies from 5 to 15 minutes. These exercises are done for 6 weeks and three sessions per week.</i_keyword>
      <i_keyword>Intervention group: Lumbar Stabilization exercises- LSEs are used to create segmental stability as well as improving movement control with qualifying and quantifying of movements. Exercises are performed by the subjects under the direct supervision of the examiner. The approximate time of each exercising session is between 40 and 50 minutes. These exercises are in 6 weeks of 3 sessions. There should be a 48-hour interval between exercising sessions. Exercises included 1.Curl-ups, 2.Dead bug, 3.Bird dog 4.Seated hip flexion, 5.Heel slides , 6.Bridge, 7.Sidebridge, 8.Standing theraband exercises.</i_keyword>
      <i_keyword>Control group: The control group do not perform any specific exercise activities which affect the research results</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Movement control. Timepoint: Before, 42 days and 28 days after intervention. Method of measurement: Lumajoki movement control tests to diagnose people with lumbar spine control disorder.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before, 42 days and 28 days after intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Hip muscle flexibility. Timepoint: Before, 42 days and 28 days after intervention. Method of measurement: Goniometer, which uses the goniometer method to assess the flexibility of the muscles of the Rectus Femoris, Hamstring, External rotator, and Tensor fasciaelatae on both sides of the body.</prim_outcome>
      <prim_outcome>Lower extremity function. Timepoint: Before, 42 days and 28 days after intervention. Method of measurement: In the present study, lower extremity function will be measured by five tests: static balance,Y Test, Triple hop for distance, Six-meter timed hop and a questionnaire on lower extremity function (Lower Extremity Functional Scale) will be used.</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>University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-11</approval_date>
        <contact_name>National Ethics Committee of Biomedical Research</contact_name>
        <contact_address>Amirabad - Faculty of Physical Education, University of Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
