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/NCT05987111</url>
    </required_header>
    <id_info>
      <org_study_id>Exercise</org_study_id>
      <nct_id>NCT05987111</nct_id>
    </id_info>
    <brief_title>Pilates in Ankylosing Spondylitis</brief_title>
    <official_title>Comparison of Efficacy of Two Different Pilates Exercise Methods in Individuals With Ankylosing Spondylitis: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pamukkale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pamukkale 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>
        This study was planned to examine and compare the effectiveness of two different pilates&#xD;
        exercise methods (mat pilates vs reformer pilates) in individuals with Ankylosing&#xD;
        Spondylitis(AS).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 2, 2022</start_date>
    <completion_date type="Actual">February 10, 2023</completion_date>
    <primary_completion_date type="Actual">December 15, 2022</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bath Ankylosing Spondylitis Metrology Index</measure>
      <time_frame>10 minutes</time_frame>
      <description>This index consists of 5 measurements: cervical rotation, tragus to wall distance, lumbar side flexion, modified Schober's, intermalleolar distance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bath Ankylosing Spondylitis Disease Activity Index</measure>
      <time_frame>5minutes</time_frame>
      <description>BASDAI consists of 6 questions evaluating the patient's level of weakness/fatigue, spinal pain, joint pain/swelling and sensitivity to touch, and duration of morning stiffness in the last week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bath Ankylosing Spondylitis Functional Index (BASFI)</measure>
      <time_frame>5 minutes</time_frame>
      <description>This scale, which evaluates the functional limitation of AS patients in activities of daily living, consists of 10 questions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ankylosing Spondylitis Quality of Life Questionnaire</measure>
      <time_frame>5 minutes</time_frame>
      <description>This questionnaire, which evaluates disease-specific quality of life, consists of 18 questions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maastrich Ankylosing Spondylitis Enthesitis Score</measure>
      <time_frame>5minutes</time_frame>
      <description>Its validity and reliability were defined to evaluate enthesopathy and peripheral joint involvement.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multidimensional Assessment of Fatigue Scale</measure>
      <time_frame>5 minutes</time_frame>
      <description>MAF scale evaluates the level of fatigue during daily activities in the last week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biopsychosocial Questionnaire (BETY-BQ)</measure>
      <time_frame>10minutes</time_frame>
      <description>The BETY-BQ evaluates the biopsychosocial status of patients with rheumatic diseases.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Ankylosing Spondylitis</condition>
    <arm_group>
      <arm_group_label>Mat Pilates</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Mat Pilates Exercises</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Reformer Pilates</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Reformer Pilates Exercises</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pilates</intervention_name>
      <description>Pilates exercises were applied twice a week for 4 weeks in both groups. The sessions were supervised by an Australian Physiotherapy and Pilates Institute (APPI) certified physiotherapist as 5 minutes of warm-up, 45 minutes of exercise and 5 minutes of cool-down periods.</description>
      <arm_group_label>Mat Pilates</arm_group_label>
      <arm_group_label>Reformer Pilates</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being in the age range of 20-65, using stable medication for at least 3 months, being&#xD;
               sedentary (Not regularly participating in exercise activities for the past 3 months).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  the presence of cardiovascular, pulmonary, orthopedic and neurological problems,&#xD;
               another rheumatic disease, being pregnant, inability to participate in at least 75% of&#xD;
               the exercises.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Usak University</name>
        <address>
          <city>Usak</city>
          <state>Merkez</state>
          <zip>64200</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uşak University</investigator_affiliation>
      <investigator_full_name>Elif Gur Kabul</investigator_full_name>
      <investigator_title>principal investigator</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>Spondylitis, Ankylosing</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/NCT05987111
  org study id: Exercise
  nct id: NCT05987111
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned to examine and compare the effectiveness of two different pilates
        exercise methods (mat pilates vs reformer pilates) in individuals with Ankylosing
        Spondylitis(AS).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Bath Ankylosing Spondylitis Metrology Index
  time frame: 10 minutes
  description: This index consists of 5 measurements: cervical rotation, tragus to wall distance, lumbar side flexion, modified Schober's, intermalleolar distance.
  measure: Bath Ankylosing Spondylitis Disease Activity Index
  time frame: 5minutes
  description: BASDAI consists of 6 questions evaluating the patient's level of weakness/fatigue, spinal pain, joint pain/swelling and sensitivity to touch, and duration of morning stiffness in the last week.
  measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
  time frame: 5 minutes
  description: This scale, which evaluates the functional limitation of AS patients in activities of daily living, consists of 10 questions.
  measure: Ankylosing Spondylitis Quality of Life Questionnaire
  time frame: 5 minutes
  description: This questionnaire, which evaluates disease-specific quality of life, consists of 18 questions
  measure: Maastrich Ankylosing Spondylitis Enthesitis Score
  time frame: 5minutes
  description: Its validity and reliability were defined to evaluate enthesopathy and peripheral joint involvement.
  measure: Multidimensional Assessment of Fatigue Scale
  time frame: 5 minutes
  description: MAF scale evaluates the level of fatigue during daily activities in the last week.
  measure: Biopsychosocial Questionnaire (BETY-BQ)
  time frame: 10minutes
  description: The BETY-BQ evaluates the biopsychosocial status of patients with rheumatic diseases.
  arm group label: Mat Pilates
  arm group type: Active Comparator
  description: Mat Pilates Exercises
  arm group label: Reformer Pilates
  arm group type: Experimental
  description: Reformer Pilates Exercises
  intervention type: Behavioral
  intervention name: Pilates
  description: Pilates exercises were applied twice a week for 4 weeks in both groups. The sessions were supervised by an Australian Physiotherapy and Pilates Institute (APPI) certified physiotherapist as 5 minutes of warm-up, 45 minutes of exercise and 5 minutes of cool-down periods.
  arm group label: Mat Pilates
  arm group label: Reformer Pilates
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Uşak University
  investigator full name: Elif Gur Kabul
  investigator title: principal investigator
  mesh term: Spondylitis
  mesh term: Spondylarthritis
  mesh term: Spondylitis, Ankylosing
  sharing ipd: No