<?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>IRCT20220924056027N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-26</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>the effect of core stability exercises on the patient's quality of life after lumbar spine surgery</public_title>
      <acronym></acronym>
      <scientific_title>the effect of core stability exercises on the patient's quality of life after lumbar spine surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66975</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sequence of random allocation was determined by a member of the research team not involved in the selection of samples and was used in sealed sealed envelopes in order of numbering to hide the allocation. Exercise therapy group patients should visit the clinic on even days and control group patients on odd days, Blinding description: The patient receives the type of intervention in a sealed envelope that is coded. Coding is done by one of the colleagues, and the patient does not know in which exercise therapy group he is placed, and the quality of life  evaluator does not know about the treatment received by the patient.The patients of the exercise therapy group visit the clinic on even days and the control group on odd days. Also, evaluations before and after the intervention are done by a person who does not know about the presence of patients in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>lumbar herniation discopathy.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, patients receive core stability exercises stage one and two. exercise training is given under the supervision of the person in charge of the treatment and explained to the patient that 15 to 20 minutes of exercises should be done at home every day. Phase one of core stability exercises begins one month after surgery and is performed daily for two months. In the third month,  the second stage of core stability are performed that continues for sixth month. Intervention 2: Control group: In the control group, the usual stretching exercises of the lower limbs and spine are taught, which should be done daily for 15 to 20 minutes. These training are given under the supervision of the person in charge of treatment, and the duration of doing sports, like the intervention group, should continue for 6 months.</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:
SPSS file data can be shared

When:
After printing the article

To whom:
RESEARCHERS

Conditions:
Secondary studies

Where to obtain:
Correspond by email

How to obtain:
Send after receiving email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>omidvar rezaeimirghaed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>loghman hakim hospital, makhsos St, kargar Ave</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333635445</zip>
        <telephone>+98 21 5102 5000</telephone>
        <email>omidvarrezaee@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>omidvar rezaeimirghaed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>loghman hakim,makhsos St, south karegar Ave</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333635445</zip>
        <telephone>+98 21 5102 5000</telephone>
        <email>dromidvarrezaee@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Patients (male and female) aged 18 to 65 with lumbar discopathy who must undergo decompression surgery                   -Having a referral letter from a neurosurgeon                                    -Full consent of the patient to participate in the research                 -Mental state of pain                                                                            - Absence of acute traumatic injury in the spine                                - Absence of injury in the spine                                                            - Absence of malignancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>-Suffering from neuro-muscular diseases                                              -suffering from a malignant tumor                                                      -suffering from chronic diseases or other known conditions that affect the research                                                                               -participating in physical therapy or exercise therapy programs during the last three months                                                                - unwillingness to participate in the research plan                            -Failure to complete treatment plans                                                  -receiving any treatment other than the treatment prescribed in this research plan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other thoracic, thoracolumbar and lumbosacral intervertebral disc disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, patients receive core stability exercises stage one and two. exercise training is given under the supervision of the person in charge of the treatment and explained to the patient that 15 to 20 minutes of exercises should be done at home every day. Phase one of core stability exercises begins one month after surgery and is performed daily for two months. In the third month,  the second stage of core stability are performed that continues for sixth month.</i_keyword>
      <i_keyword>Control group: In the control group, the usual stretching exercises of the lower limbs and spine are taught, which should be done daily for 15 to 20 minutes. These training are given under the supervision of the person in charge of treatment, and the duration of doing sports, like the intervention group, should continue for 6 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before, 1, 3 and 6 months after surgery. Method of measurement: WHOQOL-BREF questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-24</approval_date>
        <contact_name>Organizational Committee of Ethics in Biomedical Research of Shahid Beheshti University of Medical S</contact_name>
        <contact_address>loghman hakim hospital , makhsos St , south kargar Ave tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
