<?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>IRCT20220715055473N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-09</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>The effect of flexibility exercises and movement control on athletes with chronic back pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8-week flexibility and movement learning interventions on pain and disability and proprioception and two-dimensional kinematics of athletes with non-specific chronic back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66534</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple Random Sampling, , patients will be divided into two intervention groups and one control group through the method of sealed envelope after selection and informed consent to participate in the study. Numbers are written inside the envelope, which the subjects do not know about. Based on the number of 36 subjects, 12 people will be in the first experimental group, 12 people will be in the second experimental group, and 12 people will be in the control group, Blinding description: in this study, the outcome assessor will be blinded of the process of randomization and division of individuals into two experimental groups and control group. Another researcher(blinded to the baseline assessment) will proceed with training according to the group assignment. A blinded outcome assessor who does not know the hypothesis and study methods, measures outcome at baseline and 8 weeks post intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonspecific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: the combination of flexibility exercises and movement control exercises. An 8-week program of exercises (two 50-minute sessions per week) will be implemented. Treatment sessions will be at least 48 hours apart. Stretching exercises will consist of 3 sets of each exercise and the position will be maintained for 20 seconds with 30 seconds rest between sets and exercises.Stretching exercises will be static, which includes unilateral stretching exercises. Intervention 2: The second intervention group: only movement control exercises, 2 sessions per week.Only movement control exercises will be performed 2 sessions per week. An 8-week program of back stabilization exercises, as well as endurance-resistance exercises for the back muscles will be performed. In addition to back stability exercises, overload exercises such as sit-ups, side planks, and hip bridges will be performed.The number of times the movement is performed will be different depending on the type of movement and in some movements, the movement will be performed isometrically. Intervention 3: Control group: will not receive any intervention.</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:
Only data related to demographics and outcomes are shared.

When:
After publishing the article/articles extracted from the study

To whom:
The data can be displayed and shared upon the reasonable request of Iran's clinical trial registration center, journals and academic people/researchers who are conducting research and scientific activities in this field.

Conditions:
Data analysis and the use of documents can only be done under the condition that their results are mentioned in systematic review articles conducted by academic researchers and authors. The necessary conditions for sending data and documents include: 1. Sending an email (preferably with an address Valid academic addresses) to one of the researchers of the study 2. A brief and logical explanation regarding the use of data or documents 3. Ensuring the protocol registration of systematic review studies that have requested access to data or documents.

Where to obtain:
Through a request from the researchers of the study Mahsa ghavidel mahsaghavidel.mg@gmail.com Dr. Malihe Hadadnezhad - m.hadadnezhad@yahoo.com Dr. Raghad Memar - m_raghad@yahoo.com

How to obtain:
The applicant can request details from the researchers using the message sent by email within 7 to 10 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Haddadanjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz Province, Karaj, Hesarak, Beheshti Blvd,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۷۵۵۱- ۳۱۹۷۹</zip>
        <telephone>+98 26 3457 9600</telephone>
        <email>m.hadadnezhad@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe haddadnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>KhU, University Sq., Shahid Beheshti Street, Karaj, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۷۵۵۱- ۳۱۹۷۹</zip>
        <telephone>+98 26 3457 9600</telephone>
        <email>m.hadadnezhad@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Normal body mass index (18.5-24.9)
athletes who have competed at the club, national and international levels
Athletes aged between 18-50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participation in the program of rehabilitation exercises and therapeutic exercises in the last year
Serious injuries or poor health conditions that can prevent patients from performing an exercise program
Imaging findings such as osteoarthritis (grade 3-4)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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>The first intervention group: the combination of flexibility exercises and movement control exercises. An 8-week program of exercises (two 50-minute sessions per week) will be implemented. Treatment sessions will be at least 48 hours apart. Stretching exercises will consist of 3 sets of each exercise and the position will be maintained for 20 seconds with 30 seconds rest between sets and exercises.Stretching exercises will be static, which includes unilateral stretching exercises</i_keyword>
      <i_keyword>The second intervention group: only movement control exercises, 2 sessions per week.Only movement control exercises will be performed 2 sessions per week. An 8-week program of back stabilization exercises, as well as endurance-resistance exercises for the back muscles will be performed. In addition to back stability exercises, overload exercises such as sit-ups, side planks, and hip bridges will be performed.The number of times the movement is performed will be different depending on the type of movement and in some movements, the movement will be performed isometrically.</i_keyword>
      <i_keyword>Control group: will not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Non specific chronic low back pain. Timepoint: 8 weeks before and after the intervention. Method of measurement: pain rating scale( Visual Analogue Scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>2 dimensional kinematics. Timepoint: 8 weeks before and after the intervention. Method of measurement: Assessment of the movement of rising up from chair by using kinovea software.</sec_outcome>
      <sec_outcome>Proprioception. Timepoint: 8 weeks before and after the intervention. Method of measurement: the lumbar angle active reconstruction test.</sec_outcome>
      <sec_outcome>Hamstring flexibility. Timepoint: 8 weeks before and after the intervention. Method of measurement: Using passive knee extension test.</sec_outcome>
      <sec_outcome>Movement control. Timepoint: 8 weeks before and after the intervention. Method of measurement: movement control test( luomajoki 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>This study was conducted by researchers and no institutional funding was received.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-20</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute</contact_name>
        <contact_address>Ministry of Health and Medical Education, Simaye Iran Street, Shahrak-e Qods, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
