<?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>IRCT20130121012210N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison between the different corrective exercises along with Diet on improvement of Low Back Pain Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the different type of corrective exercises along with Diet on Anterior Pelvic Tilt in obesity Impacting Low Back Pain Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68862</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects in this study are randomly placed in one of the three study groups based on random number table and receive the intervention related to the same group, Blinding description: assessor is blind regarding to the groups and interventions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The participants would be assessed by a nutritionist and their basal metabolic rate (BMR) would be calculated  and finally Recommended Caloric Requirement (RCR) calculation. In RCR 500 kcal deficit would be given which is equivalent to one pound of fat which contains 3500 kcal in week. The participants will follow the regimen for 6 weeks. Intervention 2: Intervention group: Diet + Soft tissue release Group, This group would follow the same diet of control group. In Addition soft tissue release for Iliopsoas and Rectus femoris would be given for 6 weeks, 5 times per week (30 sessions). Intervention 3: Intervention group: Diet + Strengthening exercise Group, The same protocol for diet would be given. In addition strengthening training  for Pectoralis major , Lattismus Dorsi , Deltoid , Trapezius , Biceps, Triceps, Quadriceps , Hamstrings, Rectus abdominus  , Erector spinae and Gastrocnemius soleus would be formulated and supervised for 6 weeks, 5 sessions per week (30 sessions). Intervention 4: Intervention group: Diet + Aerobic exercise Group, The same protocol for diet would be given. In addition aerobic training which will be apply by  exercise between 70% to 75% of Max Heart Rate for 40 minutes per session for 5 days per week for 6 weeks (30 sessions).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more Data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Sarfraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Piche Shemiran, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>mohdpk23@hotmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Shadmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Piche shemiran, Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>shadmehr@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects with NSLBP
Age between 25 to 40years
Anterior pelvic tilt more than 13.5 degree
Grade I and II obesity</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>ِDermatological or inflammatory illness
Recent fractures
Congenital lower extremity abnormalities
Cardiovascular, pulmonary, renal and hematological disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S30.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Contusion of lower back and pelvis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The participants would be assessed by a nutritionist and their basal metabolic rate (BMR) would be calculated  and finally Recommended Caloric Requirement (RCR) calculation. In RCR 500 kcal deficit would be given which is equivalent to one pound of fat which contains 3500 kcal in week. The participants will follow the regimen for 6 weeks.</i_keyword>
      <i_keyword>Intervention group: Diet + Soft tissue release Group, This group would follow the same diet of control group. In Addition soft tissue release for Iliopsoas and Rectus femoris would be given for 6 weeks, 5 times per week (30 sessions)</i_keyword>
      <i_keyword>Intervention group: Diet + Strengthening exercise Group, The same protocol for diet would be given. In addition strengthening training  for Pectoralis major , Lattismus Dorsi , Deltoid , Trapezius , Biceps, Triceps, Quadriceps , Hamstrings, Rectus abdominus  , Erector spinae and Gastrocnemius soleus would be formulated and supervised for 6 weeks, 5 sessions per week (30 sessions).</i_keyword>
      <i_keyword>Intervention group: Diet + Aerobic exercise Group, The same protocol for diet would be given. In addition aerobic training which will be apply by  exercise between 70% to 75% of Max Heart Rate for 40 minutes per session for 5 days per week for 6 weeks (30 sessions).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: according to the Visual analog scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: Oswestry Disability Index questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: SF-36 questionnaire.</prim_outcome>
      <prim_outcome>Pelvic Tilt. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: photogrammetry.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: Bioelectrical impedance analysis.</prim_outcome>
      <prim_outcome>Muscle strength. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>Muscle thickness. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: Ultrasounography.</prim_outcome>
      <prim_outcome>Aerobic Fitness. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: Bruce Protocol.</prim_outcome>
      <prim_outcome>Waist-Hip Ratio. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: circumference of the waist to that of the hips by tape.</prim_outcome>
      <prim_outcome>Muscle length. Timepoint: before treatment, at the end of treatment (after the 6th week). Method of measurement: Thomas Test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-18</approval_date>
        <contact_name>Ethics commeetee of Tehran University of Medical sciences</contact_name>
        <contact_address>Central building of TUMS,Ghods Street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
