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/NCT05968469</url>
    </required_header>
    <id_info>
      <org_study_id>ASHIIT2023</org_study_id>
      <nct_id>NCT05968469</nct_id>
    </id_info>
    <brief_title>The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis</brief_title>
    <official_title>The Effect of Aerobic Exercise Program on Disease Activity, Quality of Life, Spinal Mobility and Serum Calprotectin, Visfatin, Leptin,IL-33 Levels in Patients With Ankylosing Spondylitis: Ultrasonographic Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Afyonkarahisar Health Sciences University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Afyonkarahisar Health Sciences 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>
        The aim of our study is to investigate the effects of aerobic exercise and stretching&#xD;
        exercises applied in high-intensity interval training protocol on disease activity, quality&#xD;
        of life, spinal mobility and calprotectin, visfatin, leptin, IL-33 serum levels in patients&#xD;
        with Ankylosing Spondylitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ankylosing spondylitis (AS) is a painful and progressive chronic inflammation of the axial&#xD;
        skeleton, mainly affecting the vertebral and sacroiliac joints. The management of AS aims to&#xD;
        improve and maintain spinal mobility and normal posture, alleviate symptoms, reduce&#xD;
        functional limitations and minimise complications. Due to the characteristic features of the&#xD;
        disease, recommended spinal mobility exercises and aerobic exercises focus on reducing&#xD;
        symptoms, improving functional capacity and quality of life, and improving and maintaining&#xD;
        spinal mobility. Calprotectin, visfatin, leptin can be evaluated as biomarkers in&#xD;
        inflammatory rheumatic diseases as an alternative to acute phase proteins and may reflect&#xD;
        disease activity.&#xD;
  &#xD;
        This study was designed as a prospective randomised controlled trial. Participants will be&#xD;
        randomized into 2 groups and the intervention group will be given aerobic exercise and&#xD;
        stretching exercise, and the other group only stretching exercise. BASDAI, BASMI, BASFI,&#xD;
        ASQOL, ASDAS-CRP, Chest Expansion, 6 Minute Walk Test and Borg Scale will be used as&#xD;
        assessment parameters.&#xD;
  &#xD;
        Calprotectin, Visfatin, Leptin, IL-33 serum levels will be analysed by ELISA kit with blood&#xD;
        samples taken in the early morning at the beginning of treatment, at the end of treatment&#xD;
        (4th week) and at the 12th week after the beginning of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 30, 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>Change in BASDAI</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consists of 6 questions about disease activity. Each question is scored on a scale of 0 to 10. High scores means high disease activity. It is a reliable and sensitive to changes index developed to assess disease activity and progression.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in BASMI</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>The Bath Ankylosing Spondylitis Metrology Index (BASMI) is related to the spinal mobility of patients with ankylosing spondylitis. It consists of 5 clinical measurements. The total score of 5 measurements is obtained, the score range is between 0-10, a lower score means better spinal mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in BASFI</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>The Bath Ankylosing Spondylitis Functional Index (BASFI) is a sensitive and reliable index developed for the determination and follow-up of functional status in patients with AS. It consists of 10 questions evaluating the functions of the patients. The final score is obtained by dividing the total score by 10 using the VAS in the range of 0-10 cm for each question. A high score indicates poor function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ASQOL</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) is the most widely used questionnaire to assess quality of life in AS, and it is valid and reliable. In this questionnaire consisting of eighteen questions, patients are asked to answer yes or no to each question. The total score varies between 0-18. High scores indicate serious deterioration in quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ASDAS-CRP</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>The Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP) consists of four questions and the acute phase reactants CRP mg/L result. ASDAS-CRP will be calculated together with the CRP result in the formula. Mild disease activity &lt;1.3 Moderate disease activity 1.3-2.1 High disease activity 2.1-3.5 Very high disease activity &gt;3.5</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Chest Expansion</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>Chest expansion is determined by measuring the chest circumference following a deep inspiration and forced expiration. The expansion of the chest circumference is recorded in centimetres.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in 6 Minute Walk Test</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The score of the test is the distance a patient walks in 6 minutes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Borg Scale</measure>
      <time_frame>Baseline, after 4 and 12 weeks</time_frame>
      <description>The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycle ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycling ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. As the activity becomes more difficult for the patient, the values given increase.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Ankylosing Spondylitis</condition>
    <condition>Aerobic Exercise</condition>
    <condition>Disease Activity</condition>
    <arm_group>
      <arm_group_label>High Intensity Interval Training (HIIT) protocol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who underwent cycling ergometry program including high-intensity interval (HIIT) in the cardiopulmonary rehabilitation unit and stretching exercises for the cervical, thoracic and lumbar regions under the guidance of a physiotherapist</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise program only:</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Aerobic exercises with cycling ergometry</intervention_name>
      <description>A total of 20 sessions of high-intensity interval (HIIT) aerobic exercise program will be applied to the patients using a bicycle ergometer, five days a week and once a day for four weeks. And then, it was planned to perform stretching exercises for the cervical, thoracic and lumbar regions and posture exercises accompanied by a specialist physiotherapist.&#xD;
  The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.</description>
      <arm_group_label>High Intensity Interval Training (HIIT) protocol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stretching exercises</intervention_name>
      <description>Stretching exercises for the cervical, thoracic and lumbar regions and posture exercises were planned to be performed with the expert physiotherapist.&#xD;
  The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.</description>
      <arm_group_label>Exercise program only:</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with ankylosing spondylitis according to 2009 ASAS diagnostic criteria,&#xD;
  &#xD;
            -  20-60 years old, male and female gender,&#xD;
  &#xD;
            -  No change in anti-rheumatic drugs and dosage in the last 3 months&#xD;
  &#xD;
            -  Those who have not done regular physical activity in the last 3 months,&#xD;
  &#xD;
            -  Patients who do not have any orthopedic, neurological or mental illness that may&#xD;
               affect exercise will be included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active malignancy and/or history of malignancy in the last 5 years,&#xD;
  &#xD;
            -  Uncontrolled cardiopulmonary disease,&#xD;
  &#xD;
            -  Unstable angina pectoris, cardiac arrhythmias and myocardial infarction within the&#xD;
               last 3 months&#xD;
  &#xD;
            -  Presence of pregnancy or those planning a pregnancy in the near future,&#xD;
  &#xD;
            -  History of major surgery (including joint surgery) within the last six months&#xD;
  &#xD;
            -  Use of assistive devices for ambulation or orthopaedic joint prosthesis&#xD;
  &#xD;
            -  Patients with total spinal ankyloses&#xD;
  &#xD;
            -  Patients with a history of syncope, exercise-induced arrhythmia&#xD;
  &#xD;
            -  Regular exercise in the last 3 months&#xD;
  &#xD;
            -  Patients with contracture of the knee joint that prevents cycling exercise&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Afyonkarahisar Health Sciences University</name>
        <address>
          <city>Afyonkarahisar</city>
          <zip>03200</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Faruk Emre YULCU</last_name>
        <phone>+905301840495</phone>
        <email>farukemreyulcu@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/30278577/</url>
      <description>Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis?</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/26523029/</url>
      <description>Effects of Aerobic Training in Patients with Ankylosing Spondylitis</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/36232862/</url>
      <description>Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis</description>
    </link>
    <reference>
      <citation>Yurdakul OV, Rezvani A. Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis? Medicine (Baltimore). 2018 Sep;97(39):e12609. doi: 10.1097/MD.0000000000012609.</citation>
      <PMID>30278577</PMID>
    </reference>
    <results_reference>
      <citation>Jennings F, Oliveira HA, de Souza MC, Cruz Vda G, Natour J. Effects of Aerobic Training in Patients with Ankylosing Spondylitis. J Rheumatol. 2015 Dec;42(12):2347-53. doi: 10.3899/jrheum.150518. Epub 2015 Nov 1.</citation>
      <PMID>26523029</PMID>
    </results_reference>
    <results_reference>
      <citation>Diaconu AD, Ceasovschih A, Sorodoc V, Pomirleanu C, Lionte C, Sorodoc L, Ancuta C. Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis. Int J Mol Sci. 2022 Sep 30;23(19):11561. doi: 10.3390/ijms231911561.</citation>
      <PMID>36232862</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Afyonkarahisar Health Sciences University</investigator_affiliation>
      <investigator_full_name>Faruk Emre Yulcu</investigator_full_name>
      <investigator_title>Research Assistant Doctor, Physical Medicine and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>Ankylosing Spondylitis</keyword>
    <keyword>Spinal Mobility</keyword>
    <keyword>Aerobic Exercise</keyword>
    <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/NCT05968469
  org study id: ASHIIT2023
  nct id: NCT05968469
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of our study is to investigate the effects of aerobic exercise and stretching
        exercises applied in high-intensity interval training protocol on disease activity, quality
        of life, spinal mobility and calprotectin, visfatin, leptin, IL-33 serum levels in patients
        with Ankylosing Spondylitis.
  Ankylosing spondylitis (AS) is a painful and progressive chronic inflammation of the axial
        skeleton, mainly affecting the vertebral and sacroiliac joints. The management of AS aims to
        improve and maintain spinal mobility and normal posture, alleviate symptoms, reduce
        functional limitations and minimise complications. Due to the characteristic features of the
        disease, recommended spinal mobility exercises and aerobic exercises focus on reducing
        symptoms, improving functional capacity and quality of life, and improving and maintaining
        spinal mobility. Calprotectin, visfatin, leptin can be evaluated as biomarkers in
        inflammatory rheumatic diseases as an alternative to acute phase proteins and may reflect
        disease activity.
  
        This study was designed as a prospective randomised controlled trial. Participants will be
        randomized into 2 groups and the intervention group will be given aerobic exercise and
        stretching exercise, and the other group only stretching exercise. BASDAI, BASMI, BASFI,
        ASQOL, ASDAS-CRP, Chest Expansion, 6 Minute Walk Test and Borg Scale will be used as
        assessment parameters.
  
        Calprotectin, Visfatin, Leptin, IL-33 serum levels will be analysed by ELISA kit with blood
        samples taken in the early morning at the beginning of treatment, at the end of treatment
        (4th week) and at the 12th week after the beginning of treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in BASDAI
  time frame: Baseline, after 4 and 12 weeks
  description: The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consists of 6 questions about disease activity. Each question is scored on a scale of 0 to 10. High scores means high disease activity. It is a reliable and sensitive to changes index developed to assess disease activity and progression.
  measure: Change in BASMI
  time frame: Baseline, after 4 and 12 weeks
  description: The Bath Ankylosing Spondylitis Metrology Index (BASMI) is related to the spinal mobility of patients with ankylosing spondylitis. It consists of 5 clinical measurements. The total score of 5 measurements is obtained, the score range is between 0-10, a lower score means better spinal mobility.
  measure: Change in BASFI
  time frame: Baseline, after 4 and 12 weeks
  description: The Bath Ankylosing Spondylitis Functional Index (BASFI) is a sensitive and reliable index developed for the determination and follow-up of functional status in patients with AS. It consists of 10 questions evaluating the functions of the patients. The final score is obtained by dividing the total score by 10 using the VAS in the range of 0-10 cm for each question. A high score indicates poor function.
  measure: Change in ASQOL
  time frame: Baseline, after 4 and 12 weeks
  description: The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) is the most widely used questionnaire to assess quality of life in AS, and it is valid and reliable. In this questionnaire consisting of eighteen questions, patients are asked to answer yes or no to each question. The total score varies between 0-18. High scores indicate serious deterioration in quality of life
  measure: Change in ASDAS-CRP
  time frame: Baseline, after 4 and 12 weeks
  description: The Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP) consists of four questions and the acute phase reactants CRP mg/L result. ASDAS-CRP will be calculated together with the CRP result in the formula. Mild disease activity <1.3 Moderate disease activity 1.3-2.1 High disease activity 2.1-3.5 Very high disease activity >3.5
  measure: Change in Chest Expansion
  time frame: Baseline, after 4 and 12 weeks
  description: Chest expansion is determined by measuring the chest circumference following a deep inspiration and forced expiration. The expansion of the chest circumference is recorded in centimetres.
  measure: Change in 6 Minute Walk Test
  time frame: Baseline, after 4 and 12 weeks
  description: The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The score of the test is the distance a patient walks in 6 minutes.
  measure: Change in Borg Scale
  time frame: Baseline, after 4 and 12 weeks
  description: The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycle ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycling ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. As the activity becomes more difficult for the patient, the values given increase.
  arm group label: High Intensity Interval Training (HIIT) protocol
  arm group type: Experimental
  description: Patients who underwent cycling ergometry program including high-intensity interval (HIIT) in the cardiopulmonary rehabilitation unit and stretching exercises for the cervical, thoracic and lumbar regions under the guidance of a physiotherapist
  arm group label: Exercise program only:
  arm group type: Active Comparator
  description: Patients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist
  intervention type: Device
  intervention name: Aerobic exercises with cycling ergometry
  description: A total of 20 sessions of high-intensity interval (HIIT) aerobic exercise program will be applied to the patients using a bicycle ergometer, five days a week and once a day for four weeks. And then, it was planned to perform stretching exercises for the cervical, thoracic and lumbar regions and posture exercises accompanied by a specialist physiotherapist.
  The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.
  arm group label: High Intensity Interval Training (HIIT) protocol
  intervention type: Other
  intervention name: Stretching exercises
  description: Stretching exercises for the cervical, thoracic and lumbar regions and posture exercises were planned to be performed with the expert physiotherapist.
  The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.
  arm group label: Exercise program only:
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  url: https://pubmed.ncbi.nlm.nih.gov/30278577/
  description: Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis?
  url: https://pubmed.ncbi.nlm.nih.gov/26523029/
  description: Effects of Aerobic Training in Patients with Ankylosing Spondylitis
  url: https://pubmed.ncbi.nlm.nih.gov/36232862/
  description: Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis
  citation: Yurdakul OV, Rezvani A. Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis? Medicine (Baltimore). 2018 Sep;97(39):e12609. doi: 10.1097/MD.0000000000012609.
  PMID: 30278577
  citation: Jennings F, Oliveira HA, de Souza MC, Cruz Vda G, Natour J. Effects of Aerobic Training in Patients with Ankylosing Spondylitis. J Rheumatol. 2015 Dec;42(12):2347-53. doi: 10.3899/jrheum.150518. Epub 2015 Nov 1.
  PMID: 26523029
  citation: Diaconu AD, Ceasovschih A, Sorodoc V, Pomirleanu C, Lionte C, Sorodoc L, Ancuta C. Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis. Int J Mol Sci. 2022 Sep 30;23(19):11561. doi: 10.3390/ijms231911561.
  PMID: 36232862
  responsible party type: Principal Investigator
  investigator affiliation: Afyonkarahisar Health Sciences University
  investigator full name: Faruk Emre Yulcu
  investigator title: Research Assistant Doctor, Physical Medicine and Rehabilitation
  mesh term: Spondylitis
  mesh term: Spondylarthritis
  mesh term: Spondylitis, Ankylosing
  sharing ipd: No