<?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>IRCT20191016045136N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of core stability and suspension exercise in people with lumbar disc herniation</public_title>
      <acronym>EMG</acronym>
      <scientific_title>Comparison of core stability and suspension exercise on some EMG coordinates, beta-endorphin and functional disability in people with lumbar disc herniation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49903</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Restricted randomization, Individual, random allocation roll, Sequentially
numbered, sealed, opaque envelopes (The names are written on a piece of paper and placed in similar envelopes. Then they are randomly placed in containers 1, 2 and 3 as a mark of 3 groups).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar disc herniation.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group : core stability exercises for 8 weeks, 3 sessions per week including warm-up (5 minute), exercise (40 minute) and cool down (5 minute). Exercises include  bridging (5 repetitions in form of movement-hold-back with 2-3-2 seconds and 1 minute rest between repetitions), push-up (Similar to the first case), inverted row (Similar to the first case), oblique sit-up (Similar to the first case), femur abduction (Similar to the first case), femur flexion (Similar to the first case) and  plank (1 repetition with 10 seconds hold). There are 1 minute rest between each workout and the next. Intervention 2: Second Intervention group: Suspension exercises for 8 weeks, 3 sessions per week including warm-up (5 minute), exercise (40 minute) and cool down (5 minute). Exercises include  suspension bridging (5 repetitions in form of movement-hold-back with 2-3-2 seconds and 1 minute rest between repetitions), suspension push-up (Similar to the first case), suspension inverted row (Similar to the first case), suspension oblique sit-up (Similar to the first case), suspension femur abduction (Similar to the first case), suspension femur flexion (Similar to the first case) and suspension plank (1 repetition with 10 seconds hold). There are 1 minute rest between each workout and the next. Intervention 3: Control group: Self-care methods at home (Such as how to properly sit, sleep and carry and lift loads).</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:
Part of the data, such as primary and secondary outcome information is shared

When:
Access starts 12 months after the results are published

To whom:
Researchers from academic institutions and medical therapists

Conditions:
There are no other conditions

Where to obtain:
Send request to email  yaser.mr2003@gmail.com

How to obtain:
First, the official request should be sent to the e-mail and after confirmation, other documents such as ID card and university confirmation documents should be sent. Data documents will be sent in less than a month after verification

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasser Mohebbi Rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Navab Tower, Navab Street, Golsar Crossroads</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4163774654</zip>
        <telephone>+98 31 3212 4093</telephone>
        <email>yaser.mr2003@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasser Mohebbi Rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Navab Tower, Navab Street, Golsar Crossroads</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4163774654</zip>
        <telephone>+98 31 3212 4093</telephone>
        <email>yaser.mr2003@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mild to moderate lumbar pain intensity with a visual analog scale score between 2-7 and severity of disc herniation with grade 1 and 2 (bulging and protrusion)
History of low back pain for more than three months
Not having specific diseases such as neurological diseases, cancer, diabetes, osteoporosis, etc.
Not participating in regular exercise means 3 sessions per week for at least one year
Not using other treatments for low back pain during the intervention</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Absences in training More than two  session
Dissatisfaction with continuing training
Getting Illness or injury during the intervention period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.26</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other intervertebral disc displacement, lumbar region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group : core stability exercises for 8 weeks, 3 sessions per week including warm-up (5 minute), exercise (40 minute) and cool down (5 minute). Exercises include  bridging (5 repetitions in form of movement-hold-back with 2-3-2 seconds and 1 minute rest between repetitions), push-up (Similar to the first case), inverted row (Similar to the first case), oblique sit-up (Similar to the first case), femur abduction (Similar to the first case), femur flexion (Similar to the first case) and  plank (1 repetition with 10 seconds hold). There are 1 minute rest between each workout and the next</i_keyword>
      <i_keyword>Second Intervention group: Suspension exercises for 8 weeks, 3 sessions per week including warm-up (5 minute), exercise (40 minute) and cool down (5 minute). Exercises include  suspension bridging (5 repetitions in form of movement-hold-back with 2-3-2 seconds and 1 minute rest between repetitions), suspension push-up (Similar to the first case), suspension inverted row (Similar to the first case), suspension oblique sit-up (Similar to the first case), suspension femur abduction (Similar to the first case), suspension femur flexion (Similar to the first case) and suspension plank (1 repetition with 10 seconds hold). There are 1 minute rest between each workout and the next</i_keyword>
      <i_keyword>Control group: Self-care methods at home (Such as how to properly sit, sleep and carry and lift loads)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma beta endorphin. Timepoint: 12 hours before and after intervention. Method of measurement: Blood sample- ELISA (Enzyme-linked immunosorbent).</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before and after intervention. Method of measurement: Oswestry disability index.</prim_outcome>
      <prim_outcome>Muscles activity. Timepoint: Before and after intervention. Method of measurement: Electromyography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before and after intervention. Method of measurement: Mcgill pain questionnaire.</sec_outcome>
      <sec_outcome>Lumbar range of motion. Timepoint: Before and after intervention. Method of measurement: Modified Schöber 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>Islamic Azad University- Rasht Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-22</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University-Rasht Branch</contact_name>
        <contact_address>Navab Tower- Navab Street- Golsar Crossroad Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
