<?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>IRCT20090203001637N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-01</date_registration>
      <primary_sponsor>Research Deputy of Tarbiat Modares University</primary_sponsor>
      <public_title>Acute effects of exergames on cognition in people with chronic non-specific low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Acute Effects of XBOX 360 Kinect Exergames and Core Stability Exercises on Cognition Factors, Pain, Mood, Fatigue and Fear Avoidance Beliefs in People with Chronic Non-Specific Low Back Pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In both groups, pre-assessments, interventions and post-assessments take place in a single session, Randomization description: According to the total sample size, a 48-digit random sequence is created using Online Randomization. The sequence of random numbers is then placed in opaque sealed envelopes, respectively. In order of arrival, subjects based on their envelope's number are randomly assigned to intervention one or intervention two groups, Blinding description: Participants are not aware of the allocation of study groups .Thus subjects of the two groups do not meet and assessments take place separately in even and odd days.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Exergaming group: A single exercise session (30-45 minutes, minimum to moderate intensity = 64-76% MAX HR) with Microsoft Xbox 360 Kinect games, will perform. 5 to 10 minuets in the beginning and ending of the session allocated to warm-up and cool-down. Intervention 2: Core stability exercising group: A single core stability exercise session (30-45 minutes, minimum to moderate intensity = 64-76% MAX HR) such as abdominal hollowing, bridges, plank holding, cat-camel, knee to chest, and quadruped core exercises, will perform. 5 to 10 minuets in the beginning and ending of the session allocated to warm-up and cool-down.</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:
File of intervention program protocol and statistical analysis plan through publication of thesis and writingan article

When:
Starting 6 months after publication of results

To whom:
The research team of this study and other clinical academic researchers who are studying in favor of these patients.

Conditions:
Researchers who intend to write a meta-analysis or systematic review articles are allowed to access document.

Where to obtain:
Sedighe Kahrizi ; Naghme Massah, Randy Neblett

How to obtain:
The request will be responded after getting the approval of university or the academic institution

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naghme Massah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Jalale al e ahmad Ave, Kouye Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8609 3437</telephone>
        <email>n.massah@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Kahrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8828 4511</telephone>
        <email>Kahrizis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of LBP for at least 3 months
7 &gt; VAS ≥ 3 during assessment and intervention
Not taking any painkillers 48 hours before the assessment and intervention
Having cognitive impairments based on the scores of cognitive tests in  matched healthy people
Men and women between 25 and 40 years old</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of any spinal disease or related surgery
History of cardiopulmonary disease, rheumatoid disease, and malignancy
3 &gt; VAS ≥ 7 during the assessment and intervention
BMI ≥ 25 Kg/m2
Pregnancy
Visual or auditory disturbance
Balance or vestibular impairments
Disability in learning and performing the interventional program
Previous experience of using Xbox 360 Kinect</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Exergaming group: A single exercise session (30-45 minutes, minimum to moderate intensity = 64-76% MAX HR) with Microsoft Xbox 360 Kinect games, will perform. 5 to 10 minuets in the beginning and ending of the session allocated to warm-up and cool-down.</i_keyword>
      <i_keyword>Core stability exercising group: A single core stability exercise session (30-45 minutes, minimum to moderate intensity = 64-76% MAX HR) such as abdominal hollowing, bridges, plank holding, cat-camel, knee to chest, and quadruped core exercises, will perform. 5 to 10 minuets in the beginning and ending of the session allocated to warm-up and cool-down</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Working memory. Timepoint: Pre and post intervention. Method of measurement: N-Back software.</prim_outcome>
      <prim_outcome>Attention. Timepoint: Pre and post intervention. Method of measurement: Simple Stroop test software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of pain. Timepoint: Pre and post intervention. Method of measurement: Visual analog scale (VAS).</sec_outcome>
      <sec_outcome>Fear avoidance beliefs. Timepoint: Pre and post intervention. Method of measurement: Tampa Scale of  Kinesiophobia (TSK).</sec_outcome>
      <sec_outcome>Mood. Timepoint: Pre and post intervention. Method of measurement: The Brunel Mood Scale (BRUMS-32).</sec_outcome>
      <sec_outcome>Perceived level of exertion due to exercising. Timepoint: Post intervention. Method of measurement: BORG Rating of Perceived Exertion (RPE).</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>Research Deputy of Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-23</approval_date>
        <contact_name>Tarbiat Modares University (T.M.U)</contact_name>
        <contact_address>Medical Ethics Committee, Faculty of Medical Sciences,Tarbiat Modares University, Jalal Al Ahmad Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
