<?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>IRCT20220722055522N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-03</date_registration>
      <primary_sponsor>Arak University</primary_sponsor>
      <public_title>Effects of a combined exercise intervention program with cognitive physical therapy on women with chronic non-specific low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of a combined exercise intervention program with cognitive physical therapy on pain, disability and postural sway on women with chronic non-specific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65984</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this semi-experimental research, the sample size was calculated using Gpower software for the effect size (0.5), test power (0.8) and significance level (0.05) of 42 people and 14 people in each group. Considering the possibility of dropping out in the groups, 45 women with non-specific chronic back pain (n=15) will participate in this study voluntarily according to the inclusion and exclusion criteria. The subjects will be divided into three groups randomly using the Randlist software, Blinding description: The data analyst will not have information about the grouping of the subjects and the data of the groups will be provided to her in the form of codes (1, 2 and 3).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Performing combined exercises that include eight weeks of aerobic, endurance, strength, and flexibility exercises. Intervention 2: Intervention group 2: Conducting eight weeks of combined exercises with cognitive function therapy. The combined exercises that include aerobic, endurance, strength, and flexibility exercises. The cognitive function therapy targets lifestyle modification and psychological factors to help patients with chronic low back pain. The goals of this approach are to reconceptualize pain from a biopsychosocial perspective while eliminating unhelpful beliefs, overcoming barriers to functional participation related to relevant personal goals, and adopting a healthy lifestyle. Intervention 3: Control group: They will have their usual routine of life.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University, Basij square, Arak, Iran.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>Z_raisi13@yahoo.com</email>
        <affiliation>Arak University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University, Basij square, Arak, Iran.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814947195</zip>
        <telephone>+98 86 3224 1517</telephone>
        <email>z-raeisi@araku.ac.ir</email>
        <affiliation>Basij Square, Arak University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering from non-specific chronic back pain (with a history of pain for at least 3 months)
Absence of cardiorespiratory diseases
Absence of neuromuscular diseases
Not having diabetes
No history of surgery
No history of fracture
Not having a history of serious injuries in the spine, including disc herniation
Not having obvious structural abnormalities in the spine
No difference in leg length
Obtaining a disability score equal to or greater than 4 in the Roland Morris Disability Questionnaire
Obtaining a score of at least 3 from the visual pain measurement scale</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having neuropathic pain, history of previous lumbar spine surgery
history of previous lumbar spine surgery
Mental disability
Severe mental illness
Illiteracy
If the subjects do not regularly participate in the training sessions (two consecutive sessions and three non-consecutive sessions), they will be excluded from the study.</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>Intervention group 1: Performing combined exercises that include eight weeks of aerobic, endurance, strength, and flexibility exercises.</i_keyword>
      <i_keyword>Intervention group 2: Conducting eight weeks of combined exercises with cognitive function therapy. The combined exercises that include aerobic, endurance, strength, and flexibility exercises. The cognitive function therapy targets lifestyle modification and psychological factors to help patients with chronic low back pain. The goals of this approach are to reconceptualize pain from a biopsychosocial perspective while eliminating unhelpful beliefs, overcoming barriers to functional participation related to relevant personal goals, and adopting a healthy lifestyle.</i_keyword>
      <i_keyword>Control group: They will have their usual routine of life.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before and after intervention. Method of measurement: The visual analogue scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before and after intervention. Method of measurement: The roland-morris disability questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postural sway. Timepoint: Before and after intervention. Method of measurement: Foor scan.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and after intervention. Method of measurement: SF-36questionnaire.</sec_outcome>
      <sec_outcome>Kinesiophobia. Timepoint: Before and after intervention. Method of measurement: Kinesiophobia questionnaire.</sec_outcome>
      <sec_outcome>The balance. Timepoint: Before and after intervention. Method of measurement: Y balance test.</sec_outcome>
      <sec_outcome>Walking. Timepoint: Before and after intervention. Method of measurement: Foot scan.</sec_outcome>
      <sec_outcome>Muscular endurance. Timepoint: Before and after intervention. Method of measurement: Sorensen's 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>Arak University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-20</approval_date>
        <contact_name>Ethics Committee of Arak University</contact_name>
        <contact_address>Arak University, Basij Square, Arak, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
