<?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>IRCT20200323046838N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-17</date_registration>
      <primary_sponsor>The international unit of Univercity of Kharazmy of Teheran</primary_sponsor>
      <public_title>Effect of 4 weeks prehabilitation aquatic therapy to women with chronic low back pain how candidate Laminectomy</public_title>
      <acronym>PREPARE</acronym>
      <scientific_title>Effect of 4 weeks comprehensive PREPARE aquatic therapy before Laminectomy and 8 weeks post operation for functional status, foot pressure distribution and EMG activation of core muscle in women with chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46686</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: By using random number table participants were divided in to control and intervention group, Blinding description: Clinical care staff or trainer staff were unaware of group division.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patient with chronic low back pain candidate Laminectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group or prehabilitation group participate in aquatic training 4 week before and 8 week after surgery. Aquatic exercise training for intervention group or prehabilitation group includes 3 session per week for a 4 week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down before surgery. The same program for 8 weeks including 3 session per week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down will be done by intervention group after surgery. Intervention 2: Control group:   The control group  participate only in 8 week aquatic training includes 3 session per week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down as routine rehabilitation program after surgery.</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 of the data and all kind of ways for data collection and statistical analysis publish in this study

When:
6 month after publish

To whom:
for researchers  of university or science academy

Conditions:
to use for else research

Where to obtain:
with email: mary.bashiri53@gmail.com

How to obtain:
with send email and announce me aim of request within 2 working day.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Bashiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 54, Ferdosi Alley, Morvarid Ave, Sadaf Street, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515787498</zip>
        <telephone>+98 81 3833 7019</telephone>
        <email>mary.bashiri53@gmail.com</email>
        <affiliation>International Unit Of Kharazmi University Of Tehetan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam.Bashiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 54, Ferdosi Alley, Morvarid AVE, Sadaf Street, Hamadan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515787498</zip>
        <telephone>+98 81 3833 7019</telephone>
        <email>mary.bashiri53@gmail.com</email>
        <affiliation>International Unit of Kharazmi university of Teheran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult with 30 - 60 years old
Having chronic low back pain with or with out radicolopathy
herniation of L4, L5, S1 disk by MRI
BMI within 22 - 32
no  surgical  history on spinal column , Having Tumor or malignancy ,scoliosis,  fractures and  pregnancy
Having mental health
consent for participation to study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>having surgical history on spinal column
having scoliosis
BMI&gt; 32
having malignancy  and tumor
having sevear heart disease
opiate addiction
having MS
having osteoprosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Radiculopathy, lumbar region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group or prehabilitation group participate in aquatic training 4 week before and 8 week after surgery. Aquatic exercise training for intervention group or prehabilitation group includes 3 session per week for a 4 week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down before surgery. The same program for 8 weeks including 3 session per week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down will be done by intervention group after surgery.</i_keyword>
      <i_keyword>Control group:   The control group  participate only in 8 week aquatic training includes 3 session per week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down as routine rehabilitation program after surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: At the baseline (before surgery) and after 8 weeks rehabilitation. Method of measurement: To assess pain the VAS ruler will be used.</prim_outcome>
      <prim_outcome>Foot pressure distribution. Timepoint: At the baseline (before surgery) and after 8 weeks rehabilitation. Method of measurement: Foot scan will be used to evaluate foot pressure distribution.</prim_outcome>
      <prim_outcome>Electrical activity of muscles. Timepoint: At the baseline (before surgery) and after 8 weeks rehabilitation. Method of measurement: By using  Electromyography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional status. Timepoint: At the baseline and end of rehabilitation program. Method of measurement: By using Osvestry Questionnaire Index,.</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>The international unit of Univercity of Kharazmy of Teheran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-09</approval_date>
        <contact_name>ethical committee of hammedan university of medical sciences</contact_name>
        <contact_address>No 54, ferdosi Alley, Morvarid Avenue, Sadaf Street, Hamedan city , Iran Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
