<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/NCT04451681</url>
  </required_header>
  <id_info>
    <org_study_id>BVUFTRAS1</org_study_id>
    <nct_id>NCT04451681</nct_id>
  </id_info>
  <brief_title>Evaluation of Physical Performance in Ankylosing Spondylitis Patients</brief_title>
  <official_title>Evaluation of Physical Performance in Ankylosing Spondylitis Patients by Cardiopulmonary Exercise Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ankylosing spondylitis (AS) can cause serious limitations in individuals' physical&#xD;
      performance, as it involves the musculoskeletal system and can cause ankylosis and arthritis&#xD;
      in both axial and peripheral joints. Although there are many studies showing these&#xD;
      limitations nowadays, there is a need to show these limitations with more objective data with&#xD;
      the new technology. Evaluating aerobic physical capacity; Cardiopulmonary Exercise Test&#xD;
      (KPET) is frequently used in physical performance analysis today. In this study, the&#xD;
      investigators want to observe the physical performance differences between 42 AS patients and&#xD;
      42 control group participants by applying KPET and present the expected performance losses in&#xD;
      AS patients in the literature with objective data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AS is an inflammatory disease of unknown etiology, characterized by marked inflammation in&#xD;
      the spinal joints and adjacent structures, leading to progressive and ascending bone fusion&#xD;
      in the spine. Although peripheral joint involvement is less, hip and shoulder joints are kept&#xD;
      in 1/3 of the cases. Inflammatory lesions can also be seen in extraarticular organs such as&#xD;
      eyes and heart. Due to joint involvement, limitations in lung capacity, and other&#xD;
      extra-articular involvements, physical performance may decrease in AS patients. Both spinal&#xD;
      and peripheral joint involvements and pain caused by chronic inflammatory process can lead&#xD;
      patients to a more sedentary lifestyle. Therefore, evaluation of physical performance is&#xD;
      important in patients with AS. Although there are some methods based on classical observation&#xD;
      in evaluating physical performance, Cardiopulmonary Exercise Test (KPET), where objective&#xD;
      data about aerobic capacity can be obtained, has been used frequently in scientific studies&#xD;
      in recent years. The data such as oxygen consumption, cardiac parameters and speed of the&#xD;
      patient on the treadmill in KPET are analyzed numerically; objective performance values such&#xD;
      as maximum oxygen use (VO2max), maximum heart rate, and maximum rate can be achieved. It is&#xD;
      possible to evaluate all the individuals to whom these tests are applied according to the&#xD;
      normal value ranges in the world more clearly in terms of their physical performance and to&#xD;
      reshape the exercise program especially according to the missing parameter. For this reason,&#xD;
      these methods are preferred primarily in physical performance evaluation in centers with&#xD;
      sufficient facilities.&#xD;
&#xD;
      In the literature, although subjective tests and data on physical performance decrease,&#xD;
      studies showing clear numerical data are needed. Therefore, in our study; We aim to evaluate&#xD;
      the physical performance of patients by applying KPET in our patients with AS diagnosis.&#xD;
      Thus, investigators aim to reveal the physical exercise capacity that may be decreased in&#xD;
      this patient group with objective numerical data. In addition, patients data will compare&#xD;
      with the control group of similar physical characteristics and age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>36-Item Short Form Health Survey (SF-36)</measure>
    <time_frame>Ten minutes</time_frame>
    <description>The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight sections are:&#xD;
vitality,physical functioning,bodily pain,general health perceptions,physical role,functioning,emotional role functioning,social role functioning and mental health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bath Ankylosing Spondylitis Disease Activation Index (BASDAI)</measure>
    <time_frame>Ten minutes</time_frame>
    <description>The BASDAI or Bath Ankylosing Spondylitis Disease Activity Index is a validated diagnostic test which allows a physician, usually a rheumatologist, to determine the effectiveness of a current drug therapy, or the need to institute a new drug therapy for the treatment of Ankylosing spondylitis (AS).The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS:Fatigue, Spinal pain, Arthralgia (joint pain) or swelling, Enthesitis,Morning stiffness duration, Morning stiffness severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Oxygen use (VO2max)</measure>
    <time_frame>60 minutes</time_frame>
    <description>VO2 max is the maximum rate of oxygen consumption measured during incremental exercise; that is, exercise of increasing intensity.&#xD;
The measurement of VO2 max in the laboratory provides a quantitative value of endurance fitness for comparison of individual training effects and between people in endurance training. Maximal oxygen consumption reflects cardiorespiratory fitness and endurance capacity in exercise performance. VO2 max refers to the amount of oxygen a person uses during intense or maximal exercise. Its measurement gives the amount of oxygen consumed per minute for a kilogram of body weight in milliliters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum heart rate</measure>
    <time_frame>One minutes</time_frame>
    <description>It is determined by measuring the maximum number of heartbeats observed per minute reached during the KPET.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum speed</measure>
    <time_frame>One minutes</time_frame>
    <description>It is determined by measuring the maximum average distance traveled per minute on the treadmill in meters / minute.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Ankylosing spondylitis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A total of 42 patients, who were diagnosed with AS with modified New York Criteria, and who agreed to participate in the study, will be included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A total of 42 control participants between the ages of 18-65 who agreed to participate in the study will be included in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiopulmonary exercise test</intervention_name>
    <description>Data such as oxygen consumption, cardiac parameters and speed of the patient are analyzed numerically on the treadmill in the KPET; Objective performance values such as maximum oxygen use (VO2max), maximum heart rate, respiratory capacity, and maximum rate will be obtained.</description>
    <arm_group_label>Ankylosing spondylitis</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of AS with modified New York Criteria (for AS group)&#xD;
&#xD;
          -  Being between the ages of 18-65&#xD;
&#xD;
          -  Agree to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac disease&#xD;
&#xD;
          -  History of stroke&#xD;
&#xD;
          -  Asthma or chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Deformity that may prevent exercise&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Unwilling to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bezmialem Vakif university</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BezmialemVU</name>
      <address>
        <city>İstanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ankylosing spondylitis</keyword>
  <keyword>Cardiopulmonary exercise test</keyword>
  <keyword>Aerobic physical capacity</keyword>
  <keyword>VO2max</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>


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/NCT04451681
org study id: BVUFTRAS1
nct id: NCT04451681
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ankylosing spondylitis (AS) can cause serious limitations in individuals' physical
      performance, as it involves the musculoskeletal system and can cause ankylosis and arthritis
      in both axial and peripheral joints. Although there are many studies showing these
      limitations nowadays, there is a need to show these limitations with more objective data with
      the new technology. Evaluating aerobic physical capacity; Cardiopulmonary Exercise Test
      (KPET) is frequently used in physical performance analysis today. In this study, the
      investigators want to observe the physical performance differences between 42 AS patients and
      42 control group participants by applying KPET and present the expected performance losses in
      AS patients in the literature with objective data.
AS is an inflammatory disease of unknown etiology, characterized by marked inflammation in
      the spinal joints and adjacent structures, leading to progressive and ascending bone fusion
      in the spine. Although peripheral joint involvement is less, hip and shoulder joints are kept
      in 1/3 of the cases. Inflammatory lesions can also be seen in extraarticular organs such as
      eyes and heart. Due to joint involvement, limitations in lung capacity, and other
      extra-articular involvements, physical performance may decrease in AS patients. Both spinal
      and peripheral joint involvements and pain caused by chronic inflammatory process can lead
      patients to a more sedentary lifestyle. Therefore, evaluation of physical performance is
      important in patients with AS. Although there are some methods based on classical observation
      in evaluating physical performance, Cardiopulmonary Exercise Test (KPET), where objective
      data about aerobic capacity can be obtained, has been used frequently in scientific studies
      in recent years. The data such as oxygen consumption, cardiac parameters and speed of the
      patient on the treadmill in KPET are analyzed numerically; objective performance values such
      as maximum oxygen use (VO2max), maximum heart rate, and maximum rate can be achieved. It is
      possible to evaluate all the individuals to whom these tests are applied according to the
      normal value ranges in the world more clearly in terms of their physical performance and to
      reshape the exercise program especially according to the missing parameter. For this reason,
      these methods are preferred primarily in physical performance evaluation in centers with
      sufficient facilities.

      In the literature, although subjective tests and data on physical performance decrease,
      studies showing clear numerical data are needed. Therefore, in our study; We aim to evaluate
      the physical performance of patients by applying KPET in our patients with AS diagnosis.
      Thus, investigators aim to reveal the physical exercise capacity that may be decreased in
      this patient group with objective numerical data. In addition, patients data will compare
      with the control group of similar physical characteristics and age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: 36-Item Short Form Health Survey (SF-36)
time frame: Ten minutes
description: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight sections are:
vitality,physical functioning,bodily pain,general health perceptions,physical role,functioning,emotional role functioning,social role functioning and mental health.
measure: Bath Ankylosing Spondylitis Disease Activation Index (BASDAI)
time frame: Ten minutes
description: The BASDAI or Bath Ankylosing Spondylitis Disease Activity Index is a validated diagnostic test which allows a physician, usually a rheumatologist, to determine the effectiveness of a current drug therapy, or the need to institute a new drug therapy for the treatment of Ankylosing spondylitis (AS).The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS:Fatigue, Spinal pain, Arthralgia (joint pain) or swelling, Enthesitis,Morning stiffness duration, Morning stiffness severity
measure: Maximum Oxygen use (VO2max)
time frame: 60 minutes
description: VO2 max is the maximum rate of oxygen consumption measured during incremental exercise; that is, exercise of increasing intensity.
The measurement of VO2 max in the laboratory provides a quantitative value of endurance fitness for comparison of individual training effects and between people in endurance training. Maximal oxygen consumption reflects cardiorespiratory fitness and endurance capacity in exercise performance. VO2 max refers to the amount of oxygen a person uses during intense or maximal exercise. Its measurement gives the amount of oxygen consumed per minute for a kilogram of body weight in milliliters.
measure: Maximum heart rate
time frame: One minutes
description: It is determined by measuring the maximum number of heartbeats observed per minute reached during the KPET.
measure: Maximum speed
time frame: One minutes
description: It is determined by measuring the maximum average distance traveled per minute on the treadmill in meters / minute.
arm group label: Ankylosing spondylitis
arm group type: Other
description: A total of 42 patients, who were diagnosed with AS with modified New York Criteria, and who agreed to participate in the study, will be included in this group.
arm group label: Control
arm group type: Other
description: A total of 42 control participants between the ages of 18-65 who agreed to participate in the study will be included in this group.
intervention type: Other
intervention name: Cardiopulmonary exercise test
description: Data such as oxygen consumption, cardiac parameters and speed of the patient are analyzed numerically on the treadmill in the KPET; Objective performance values such as maximum oxygen use (VO2max), maximum heart rate, respiratory capacity, and maximum rate will be obtained.
arm group label: Ankylosing spondylitis
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
sharing ipd: No