<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/NCT03807180</url>
  </required_header>
  <id_info>
    <org_study_id>60116787-020/55441</org_study_id>
    <nct_id>NCT03807180</nct_id>
  </id_info>
  <brief_title>Effects of Tai Chi in Patients With Ankylosing Spondylitis Receiving Anti-tumor Necrosis Factor Alpha Therapy</brief_title>
  <official_title>Tai Chi in Patients With Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale 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) is a chronic inflammatory rheumatic disease that causes a&#xD;
      decrease in physical activity, fatigue, sleep problems and psychological consequences such as&#xD;
      depression, anxiety and stress by primarily affecting the sacroiliac joint and spine. The aim&#xD;
      of the treatment of AS is to prevent the hardness and flexion deformity associated with the&#xD;
      disease; to maintain the patient's healthy psychological and physical condition. The first&#xD;
      step in the treatment of AS; Pharmacological treatment of NSAIDs or Anti-TNFs along with&#xD;
      exercise. Exercise, especially pain and immobility symptoms control provides patients with&#xD;
      disease is an advantage.&#xD;
&#xD;
      Tai Chi Chuan or Taiji is a traditional Chinese exercise method that has been applied for&#xD;
      more than 300 years. Exercises based on Chinese medicine and martial arts. It is a&#xD;
      combination of physical exercise and relaxation techniques and is used to improve the mental&#xD;
      and physical health of individuals. In literature, balance, strength, coordination, postural&#xD;
      control, agility, reaction time, flexibility has attracted attention for developing such&#xD;
      factors. In addition, it increases muscle strength in elderly people and decreases the risk&#xD;
      of falling; Rheumatoid arthritis and Osteoarthritis-related symptoms have been reported to&#xD;
      improve in a positive way. In the literature, there is only one study examining the efficacy&#xD;
      of Tai Chi in AS patients. According to the results of this study, Tai Chi has a positive&#xD;
      effect on disease activity and flexibility of patients with AS.&#xD;
&#xD;
      Although there is consensus on exercise role in the treatment of AS, when the literature is&#xD;
      reviewed, it is seen that the strict and definite guidelines on the type and frequency of&#xD;
      exercises are not yet described. There is no defined protocol for which specific exercise is&#xD;
      appropriate in AS. The literature considers that more information is needed on the various&#xD;
      physical therapy programs related to intensity, frequency and duration to determine the most&#xD;
      appropriate activity for the disease.&#xD;
&#xD;
      The aim of this study was to investigate the effect of Tai Chi exercises on functionality,&#xD;
      disease activity, functional exercise capacity, spinal mobility, lower extremity strength and&#xD;
      quality of life in AS patients with biological agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At least 36 AS patients followed-up by Antalya Training and Research Hospital, who are&#xD;
      receiving Anti-TNF therapy and who do not have any other disease affecting their functions&#xD;
      will be included in the study. There were 18 patients in the conventional treatment group and&#xD;
      18 patients in the Tai Chi group.&#xD;
&#xD;
      After the demographic data of AS patients were recorded, Bath AS Disease Activity Index&#xD;
      (BASDAI), Bath AS Disease Activity Index (BASFI) and Bath AS Metrology Index (BASMI),&#xD;
      respectively, to be used for activity and basic measurements of the disease, 6 minutes&#xD;
      walking test to measure aerobic capacity , Cognitive Exercise Therapy Approach Scale and&#xD;
      Ankylosing Spondylitis Quality of Life Questionnaire to be used for quality of life, 30&#xD;
      second sit-down test to evaluate the lower extremity strength. In addition, 10-20 ml (1-2&#xD;
      tubes) of blood will be taken from the patient's arm, the amount of substances such as&#xD;
      erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) in the blood will be&#xD;
      measured. Patients will not be charged any fee related to this process. Evaluation methods&#xD;
      will be applied to the cases before the start of training and after the completion of the&#xD;
      training.&#xD;
&#xD;
      For the training, both patient groups were randomly divided into two groups: the first group&#xD;
      was treated with conventional treatment and the second group with Tai Chi training. The&#xD;
      training will last 10 weeks.&#xD;
&#xD;
      Conventional treatment; stretching for the cervical, thoracic and lumbar flexibility,&#xD;
      shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for&#xD;
      abdominal, back and proximal muscles. The exercises that will be taught in detail to each&#xD;
      stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week.&#xD;
      The patients will be inspected and controlled by monthly controls.&#xD;
&#xD;
      Tai Chi exercise method, which is composed of combination of physical exercise and relaxation&#xD;
      techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi.&#xD;
      The training will take 60 minutes, 2 days a week and 10 weeks in total.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>
    <intervention_model_description>Randomized controlled</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients with Ankylosing spondylitis receiving anti-tnf alpha therapy</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Bath Ankylosing Spondylitis Functional Index (BASFI)</measure>
    <time_frame>ten weeks</time_frame>
    <description>This self-assessment instrument was designed by a team of medical professionals in conjunction with patients, and consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher scores show poor functionality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</measure>
    <time_frame>ten weeks</time_frame>
    <description>The index, designed by a multidisciplinary team with input from patients, consists of six 10 cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. Higher scores show poor disease activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bath Ankylosing Spondylitis Metrology Index (BASMI)</measure>
    <time_frame>ten weeks</time_frame>
    <description>İt is for quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement.It is included of clinical measures of cervical rotation, tragus to wall distance, lumbar flexion, lumbar side flexion, and intermalleolar distance.Each item is scored from 0-10 based on individually defined cut points. Ranges are given as cervical rotation (&gt;85.0° to ≤8.5°), tragus to wall (&lt;10 cm to ≥38 cm), lumbar flexion (&gt;7.0 cm to ≤0.7 cm), lumbar side flexion (&gt;20.0 cm to &lt;1.2 cm), and intermalleolar distance (≥120 cm to &lt;30 cm). Higher scores show poor spinal mobility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ankylosing Spondylitis Life Quality Questionnaire (ASQol),</measure>
    <time_frame>ten weeks</time_frame>
    <description>It is purpose to measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective.The questionnaire includes items related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life. It is included 18 items.Dichotomous responses, with 0 scored for a &quot;no&quot; and 1 scored for a &quot;yes&quot; for each item. Total score is the sum of the individual responses.Score range is 0-18, with higher scores reflecting greater impairment of health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minute walking test</measure>
    <time_frame>ten week</time_frame>
    <description>The maximum distance that individuals can walk in a 30-meter straight and inclined corridor for 6 minutes is recorded. Higher distances show better aerobic capacity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Spondylitis, Ankylosing</condition>
  <arm_group>
    <arm_group_label>Group of Tai Chi</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group of Tai Chi intervention include 18 patients with AS. Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional exercises are stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tai Chi (exercise)</intervention_name>
    <description>Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases.</description>
    <arm_group_label>Group of Tai Chi</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being sedentary (not routinely involved in exercise activities during the last 3&#xD;
             months).&#xD;
&#xD;
          -  We have been using fixed dose medication for at least 6 months (no change in drug&#xD;
             treatment during the study).&#xD;
&#xD;
          -  No communication problem&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Functional disorders more effective than ankylosing spondylitis;&#xD;
&#xD;
          -  Diastolic heart failure&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Severe asthma knee osteoarthritis&#xD;
&#xD;
          -  Metastatic prostate cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayse Ayan, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Antalya Education and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antalya Education and Research Hospital</name>
      <address>
        <city>Antalya</city>
        <state>Konyaalti</state>
        <zip>07070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Lee EN, Kim YH, Chung WT, Lee MS. Tai chi for disease activity and flexibility in patients with ankylosing spondylitis--a controlled clinical trial. Evid Based Complement Alternat Med. 2008 Dec;5(4):457-62. doi: 10.1093/ecam/nem048. Epub 2007 Jul 13.</citation>
    <PMID>18955296</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 11, 2020</last_update_submitted>
  <last_update_submitted_qc>January 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Bilge Basakci Calik</investigator_full_name>
    <investigator_title>Assoc Prof, PT</investigator_title>
  </responsible_party>
  <keyword>Tai Chi</keyword>
  <keyword>ankylosing spondylitis</keyword>
  <keyword>functionality</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>
    <ipd_description>We will use Statistical package for the social sciences (SPSS) for participant data after interventions</ipd_description>
  </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/NCT03807180
org study id: 60116787-020/55441
nct id: NCT03807180
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ankylosing Spondylitis (AS) is a chronic inflammatory rheumatic disease that causes a
      decrease in physical activity, fatigue, sleep problems and psychological consequences such as
      depression, anxiety and stress by primarily affecting the sacroiliac joint and spine. The aim
      of the treatment of AS is to prevent the hardness and flexion deformity associated with the
      disease; to maintain the patient's healthy psychological and physical condition. The first
      step in the treatment of AS; Pharmacological treatment of NSAIDs or Anti-TNFs along with
      exercise. Exercise, especially pain and immobility symptoms control provides patients with
      disease is an advantage.

      Tai Chi Chuan or Taiji is a traditional Chinese exercise method that has been applied for
      more than 300 years. Exercises based on Chinese medicine and martial arts. It is a
      combination of physical exercise and relaxation techniques and is used to improve the mental
      and physical health of individuals. In literature, balance, strength, coordination, postural
      control, agility, reaction time, flexibility has attracted attention for developing such
      factors. In addition, it increases muscle strength in elderly people and decreases the risk
      of falling; Rheumatoid arthritis and Osteoarthritis-related symptoms have been reported to
      improve in a positive way. In the literature, there is only one study examining the efficacy
      of Tai Chi in AS patients. According to the results of this study, Tai Chi has a positive
      effect on disease activity and flexibility of patients with AS.

      Although there is consensus on exercise role in the treatment of AS, when the literature is
      reviewed, it is seen that the strict and definite guidelines on the type and frequency of
      exercises are not yet described. There is no defined protocol for which specific exercise is
      appropriate in AS. The literature considers that more information is needed on the various
      physical therapy programs related to intensity, frequency and duration to determine the most
      appropriate activity for the disease.

      The aim of this study was to investigate the effect of Tai Chi exercises on functionality,
      disease activity, functional exercise capacity, spinal mobility, lower extremity strength and
      quality of life in AS patients with biological agents.
At least 36 AS patients followed-up by Antalya Training and Research Hospital, who are
      receiving Anti-TNF therapy and who do not have any other disease affecting their functions
      will be included in the study. There were 18 patients in the conventional treatment group and
      18 patients in the Tai Chi group.

      After the demographic data of AS patients were recorded, Bath AS Disease Activity Index
      (BASDAI), Bath AS Disease Activity Index (BASFI) and Bath AS Metrology Index (BASMI),
      respectively, to be used for activity and basic measurements of the disease, 6 minutes
      walking test to measure aerobic capacity , Cognitive Exercise Therapy Approach Scale and
      Ankylosing Spondylitis Quality of Life Questionnaire to be used for quality of life, 30
      second sit-down test to evaluate the lower extremity strength. In addition, 10-20 ml (1-2
      tubes) of blood will be taken from the patient's arm, the amount of substances such as
      erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) in the blood will be
      measured. Patients will not be charged any fee related to this process. Evaluation methods
      will be applied to the cases before the start of training and after the completion of the
      training.

      For the training, both patient groups were randomly divided into two groups: the first group
      was treated with conventional treatment and the second group with Tai Chi training. The
      training will last 10 weeks.

      Conventional treatment; stretching for the cervical, thoracic and lumbar flexibility,
      shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for
      abdominal, back and proximal muscles. The exercises that will be taught in detail to each
      stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week.
      The patients will be inspected and controlled by monthly controls.

      Tai Chi exercise method, which is composed of combination of physical exercise and relaxation
      techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi.
      The training will take 60 minutes, 2 days a week and 10 weeks in total.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled
primary purpose: Other
masking: Single (Participant)
masking description: Patients with Ankylosing spondylitis receiving anti-tnf alpha therapy
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
time frame: ten weeks
description: This self-assessment instrument was designed by a team of medical professionals in conjunction with patients, and consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher scores show poor functionality.
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
time frame: ten weeks
description: The index, designed by a multidisciplinary team with input from patients, consists of six 10 cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. Higher scores show poor disease activity.
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
time frame: ten weeks
description: İt is for quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement.It is included of clinical measures of cervical rotation, tragus to wall distance, lumbar flexion, lumbar side flexion, and intermalleolar distance.Each item is scored from 0-10 based on individually defined cut points. Ranges are given as cervical rotation (>85.0° to ≤8.5°), tragus to wall (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Higher scores show poor spinal mobility.
measure: Ankylosing Spondylitis Life Quality Questionnaire (ASQol),
time frame: ten weeks
description: It is purpose to measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective.The questionnaire includes items related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life. It is included 18 items.Dichotomous responses, with 0 scored for a "no" and 1 scored for a "yes" for each item. Total score is the sum of the individual responses.Score range is 0-18, with higher scores reflecting greater impairment of health-related quality of life.
measure: 6 minute walking test
time frame: ten week
description: The maximum distance that individuals can walk in a 30-meter straight and inclined corridor for 6 minutes is recorded. Higher distances show better aerobic capacity
arm group label: Group of Tai Chi
arm group type: Other
description: Group of Tai Chi intervention include 18 patients with AS. Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total.
arm group label: Group of control
arm group type: No Intervention
description: Conventional exercises are stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls.
intervention type: Other
intervention name: Tai Chi (exercise)
description: Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases.
arm group label: Group of Tai Chi
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ayse Ayan, Dr
role: Study Chair
affiliation: Antalya Education and Research Hospital
facility: 
country: Turkey
citation: Lee EN, Kim YH, Chung WT, Lee MS. Tai chi for disease activity and flexibility in patients with ankylosing spondylitis--a controlled clinical trial. Evid Based Complement Alternat Med. 2008 Dec;5(4):457-62. doi: 10.1093/ecam/nem048. Epub 2007 Jul 13.
PMID: 18955296
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Bilge Basakci Calik
investigator title: Assoc Prof, PT
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
sharing ipd: No
ipd description: We will use Statistical package for the social sciences (SPSS) for participant data after interventions