xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000072</url>
    </required_header>
    <id_info>
      <org_study_id>ATADEK 2023 - 10/341</org_study_id>
      <nct_id>NCT06000072</nct_id>
    </id_info>
    <brief_title>Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis</brief_title>
    <official_title>Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Acibadem University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Haydarpasa Numune Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Acibadem University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Exercise is a core treatment method in the management of Axial Spondyloarthritis. Clinical&#xD;
        guidelines recommend a combination of pharmacologic and non-pharmacologic approaches to&#xD;
        reduce disease activity and symptoms and improve physical function. The COVID-19 pandemic has&#xD;
        accelerated the provision of healthcare services remotely and the digitalization of&#xD;
        rehabilitation services. Telerehabilitation methods provide advantages in terms of&#xD;
        transportation, prevention of infections that may occur due to suppression of immunity with&#xD;
        drugs, and continuity of treatment in patients with axial spondyloarthritis. In this context,&#xD;
        it is important to evaluate the effects of remote physiotherapy and rehabilitation delivery&#xD;
        in chronic inflammatory rheumatic diseases. This study, which will examine the effects of&#xD;
        telerehabilitation in the disease management processes of individuals with axial&#xD;
        spondyloarthritis, is thought to shed light on future studies.&#xD;
  &#xD;
        The aim of this study was to compare the effectiveness of telerehabilitation or pre-recorded&#xD;
        video-based core exercise program on core endurance, disease activity and physical function&#xD;
        in subjects with axial spondyloarthritis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 11, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Core Endurance Tests : Trunk Flexion Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient will be asked to cross his/her hands over his/her chest and positioned with the trunk in 60° flexion and knees in 90° flexion. The time in this position will be measured and recorded with a stopwatch. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Core Endurance Tests : Side Plank (Side Bridge Test):</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient will be asked to lie on his/her side on the dominant side and cross his/her foot over the other foot. The non-dominant arm will be crossed over the chest and placed over the dominant shoulder. The patient will be asked to stand on the dominant forearm and elbow. The time in this position will be measured with a cronometer and recorded. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Core Endurance Tests : Modified Plank</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient will be asked to position on his/her knees and elbows with his/her face to the floor. He/she will be fixed over his/her knees with the help of a belt and the duration of his/her stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Core Endurance Tests : Biering-Sorenson Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>Patients will be positioned in a prone position with their spina iliaca anterior superior to the edge of the bed. Participants will be asked to extend their upper body straight forward from the edge of the table. They will be immobilized over their knees with the help of a belt and the time they stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Core Endurance Tests : 30 Second Sit and Stand Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient sits and stands for 30 s in a chair whose height is adjusted so that the knees are 90° when seated. The number of times the patient can sit and stand during this time will be calculated and recorded.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bath Ankylosing Spondylitis Functional Index (BASFI)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The questionnaire used to assess physical function in patients consists of 10 items related to activities of daily living. Each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The BASDAI is used to measure ankylosing spondylitis disease activity. In this index, fatigue, pain due to spinal and peripheral joint involvement, local tenderness at the sites of insertion, duration and severity of morning stiffness in the last 1 week are evaluated. It consists of a total of 6 items and each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bath Ankylosing Spondylitis Metrology Index (BASMI)</measure>
      <time_frame>8 weeks</time_frame>
      <description>It is an index that includes several measurements used to evaluate spinal mobility. These measurements are tragus-wall distance, lumbar lateral flexion test, Modified Schober test, intermalleolar distance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global Rating of Change (GROC)</measure>
      <time_frame>8 weeks</time_frame>
      <description>It is used to assess the patient's current health status and to calculate the difference between the initial health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain intensity (Numeric Rating Scale/NRS)</measure>
      <time_frame>8 weeks</time_frame>
      <description>It is a scale used to determine the severity of pain. It allows the patient to describe their pain in numbers. The scale starts with the absence of pain (0) and is expressed as unbearable pain (10 or 100).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Axial Spondyloarthritis</condition>
    <condition>Telerehabilitation</condition>
    <condition>Exercise</condition>
    <arm_group>
      <arm_group_label>Telerehabilitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Telerehabilitation sessions including core exercises</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Video-based</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Core exercises by watching pre-recorded videos</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Core Exercise Program</intervention_name>
      <description>Core exercises</description>
      <arm_group_label>Telerehabilitation</arm_group_label>
      <arm_group_label>Video-based</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 - 55 years old,&#xD;
  &#xD;
            -  Axial Spondyloarthritis diagnosed by a rheumatologist,&#xD;
  &#xD;
            -  Not having any orthopedic, neurological, or mental illness that would affect exercise,&#xD;
  &#xD;
            -  Not using any assistive device for ambulation&#xD;
  &#xD;
            -  People who volunteer to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy, malignancy, and recent surgery&#xD;
  &#xD;
            -  Presence of cardiopulmonary disease&#xD;
  &#xD;
            -  Patients with endoprosthesis and prosthesis&#xD;
  &#xD;
            -  Attending a regular exercise program (Pilates, core, or yoga etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Haydarpasa Numune Research and Training Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>34752</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatih Sarıtaş, MD</last_name>
        <phone>5337707679</phone>
        <email>fatihsaritas@yahoo.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Acıbadem Mehmet Ali Aydınlar University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Özgül Öztürk, PhD</last_name>
        <phone>2165004185</phone>
        <email>ozgul.ozturk@acibadem.edu.tr</email>
      </contact>
      <investigator>
        <last_name>Ece Nur Şen</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Acibadem University</investigator_affiliation>
      <investigator_full_name>Özgül Öztürk</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spondylitis</mesh_term>
      <mesh_term>Spondylarthritis</mesh_term>
      <mesh_term>Axial Spondyloarthritis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000072
  org study id: ATADEK 2023 - 10/341
  nct id: NCT06000072
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Exercise is a core treatment method in the management of Axial Spondyloarthritis. Clinical
        guidelines recommend a combination of pharmacologic and non-pharmacologic approaches to
        reduce disease activity and symptoms and improve physical function. The COVID-19 pandemic has
        accelerated the provision of healthcare services remotely and the digitalization of
        rehabilitation services. Telerehabilitation methods provide advantages in terms of
        transportation, prevention of infections that may occur due to suppression of immunity with
        drugs, and continuity of treatment in patients with axial spondyloarthritis. In this context,
        it is important to evaluate the effects of remote physiotherapy and rehabilitation delivery
        in chronic inflammatory rheumatic diseases. This study, which will examine the effects of
        telerehabilitation in the disease management processes of individuals with axial
        spondyloarthritis, is thought to shed light on future studies.
  
        The aim of this study was to compare the effectiveness of telerehabilitation or pre-recorded
        video-based core exercise program on core endurance, disease activity and physical function
        in subjects with axial spondyloarthritis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Core Endurance Tests : Trunk Flexion Test
  time frame: 8 weeks
  description: The patient will be asked to cross his/her hands over his/her chest and positioned with the trunk in 60° flexion and knees in 90° flexion. The time in this position will be measured and recorded with a stopwatch. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
  measure: Core Endurance Tests : Side Plank (Side Bridge Test):
  time frame: 8 weeks
  description: The patient will be asked to lie on his/her side on the dominant side and cross his/her foot over the other foot. The non-dominant arm will be crossed over the chest and placed over the dominant shoulder. The patient will be asked to stand on the dominant forearm and elbow. The time in this position will be measured with a cronometer and recorded. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
  measure: Core Endurance Tests : Modified Plank
  time frame: 8 weeks
  description: The patient will be asked to position on his/her knees and elbows with his/her face to the floor. He/she will be fixed over his/her knees with the help of a belt and the duration of his/her stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
  measure: Core Endurance Tests : Biering-Sorenson Test
  time frame: 8 weeks
  description: Patients will be positioned in a prone position with their spina iliaca anterior superior to the edge of the bed. Participants will be asked to extend their upper body straight forward from the edge of the table. They will be immobilized over their knees with the help of a belt and the time they stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
  measure: Core Endurance Tests : 30 Second Sit and Stand Test
  time frame: 8 weeks
  description: The patient sits and stands for 30 s in a chair whose height is adjusted so that the knees are 90° when seated. The number of times the patient can sit and stand during this time will be calculated and recorded.
  measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
  time frame: 8 weeks
  description: The questionnaire used to assess physical function in patients consists of 10 items related to activities of daily living. Each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible).
  measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
  time frame: 8 weeks
  description: The BASDAI is used to measure ankylosing spondylitis disease activity. In this index, fatigue, pain due to spinal and peripheral joint involvement, local tenderness at the sites of insertion, duration and severity of morning stiffness in the last 1 week are evaluated. It consists of a total of 6 items and each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible).
  measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
  time frame: 8 weeks
  description: It is an index that includes several measurements used to evaluate spinal mobility. These measurements are tragus-wall distance, lumbar lateral flexion test, Modified Schober test, intermalleolar distance.
  measure: Global Rating of Change (GROC)
  time frame: 8 weeks
  description: It is used to assess the patient's current health status and to calculate the difference between the initial health status.
  measure: Pain intensity (Numeric Rating Scale/NRS)
  time frame: 8 weeks
  description: It is a scale used to determine the severity of pain. It allows the patient to describe their pain in numbers. The scale starts with the absence of pain (0) and is expressed as unbearable pain (10 or 100).
  arm group label: Telerehabilitation
  arm group type: Experimental
  description: Telerehabilitation sessions including core exercises
  arm group label: Video-based
  arm group type: Active Comparator
  description: Core exercises by watching pre-recorded videos
  intervention type: Other
  intervention name: Core Exercise Program
  description: Core exercises
  arm group label: Telerehabilitation
  arm group label: Video-based
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Acibadem University
  investigator full name: Özgül Öztürk
  investigator title: Assistant Professor
  mesh term: Spondylitis
  mesh term: Spondylarthritis
  mesh term: Axial Spondyloarthritis
  sharing ipd: No