<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/NCT04402255</url>
  </required_header>
  <id_info>
    <org_study_id>83088843-604.01.04-5578</org_study_id>
    <nct_id>NCT04402255</nct_id>
  </id_info>
  <brief_title>Pilates Based Exercises in Patients With Behçet and Familial Mediterranean Fever.</brief_title>
  <official_title>The Effect of Pilates Based Exercise Practice on Physical and Psychological Parameters in Patients With Behçet and Familial Mediterranean Fever.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul 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>
      Behcet's disease (BD) is a chronic systemic inflammatory disease which is characterized by&#xD;
      oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as&#xD;
      arthritis, arthralgia, enthesitis and sacroiliitis can be seen in the course of BD. Familial&#xD;
      Mediterranean fever (FMF) is the most frequent autoinflammatory disease (AID) and&#xD;
      characterized by selflimited episodes of fever and polyserositis. It is the most common&#xD;
      monogenic periodic fever syndrome that affects mainly the people of Mediterranean descent.&#xD;
      Regular physical activity involving aerobic and strengthening programs in inflammatory&#xD;
      rheumatic diseases has a long-term anti-inflammatory effect. Eccentric exercises cause an&#xD;
      acute increase in TNF alpha level and should be avoided especially at the beginning. It has&#xD;
      been stated that patients should be encouraged about aerobic exercise programs where the&#xD;
      intensity is gradually increased, starting with low intensity. Pilates method is the mind and&#xD;
      body centering technique developed by Joseph Hubertus Pilates, based on providing lumbopelvic&#xD;
      stability. FMF and BH have common characteristics such as ethnicity, etiopathogenetic&#xD;
      mechanisms, symptoms, and treatment. When we look at the literature, there is no study on the&#xD;
      effectiveness of exercise applications in FMF and Behçet patients. The purpose of our study;&#xD;
      It is the comparison of the effectiveness of physical activity in patients diagnosed with&#xD;
      Behçet and FMF and healthy individuals. In this context, with the short form of the&#xD;
      International Physical Activity Evaluation Questionnaire, Behçet's patients whose physical&#xD;
      activity level is inactive will be Group 1, FMF patients Group 2 and healthy controls with&#xD;
      similar demographic characteristics will be Group 3. Pilates based exercise program will be&#xD;
      applied to all 3 groups for 8 weeks, 2 times a week.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</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>international physical activity questionnaire- short form Web sonuçları International Physical Activity Questionnaire - Short Form</measure>
    <time_frame>change from baseline to 8 weeks, follow up at two months</time_frame>
    <description>This short questionnaire, consisting of seven questions, evaluates the amount of walking done in the last week and the amount of moderate and difficult physical activities performed in work, transportation, housework, gardening and leisure activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>six minute walk test</measure>
    <time_frame>change from baseline to 8 weeks, follow up at two months</time_frame>
    <description>It is a simple test that measures the distance an individual can walk at a fast pace on a flat, hard floor in 6 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex balance system (BBS)</measure>
    <time_frame>change from baseline to 8 weeks, follow up at two months</time_frame>
    <description>The BBS has a round foot platform that moves in all planes. It grants 20 degrees of foot platform motion in different directions. The platform has foot angles and heel coordinates for proper foot placement before starting the balance test trial. The foot angles range from 0° to 45° and heel coordinates are expressed as the intersection of letters from A to P and numbers from 1 to 21. The participants were asked to centralize their body while they placed their feet in the most comfortable position and their feet 10 cm apart with eyes open. They were asked to hold the rails in case they felt unbalanced. The machine measured the magnitude of their postural sways: higher scores for postural sway indicate impaired balance, and a lower score indicate excellent balance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>change from baseline to 8 weeks, follow up at two months</time_frame>
    <description>The BBS is a 14- item balance test recognized as the gold standard tool for assessing balance (higher scores indicate better balance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Scale</measure>
    <time_frame>change from baseline to 8 weeks, follow up at two months</time_frame>
    <description>The scale was prepared as 21 items, but the last four items were not included in the scoring. The total score is determined on 17 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nottingham Health Profile Questionnaire (NHP)</measure>
    <time_frame>change from baseline to 8 weeks, follow up at two months</time_frame>
    <description>NHP were used as research tools. The Nottingham Health Profile Questionnaire was used to measure health problems perceived by the patient and to assess the effect of these problems on daily functioning</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Behcet Disease</condition>
  <condition>FMF</condition>
  <arm_group>
    <arm_group_label>behcet group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group includes 16 patients with behçet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fmf group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group includes 16 patients with fmf</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healty control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group includes 16 healthy control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pilates exercise</intervention_name>
    <description>The key elements of Pilates during supine, prone, side-lying and standing positions will be taught. These key elements are: breathing (diaphragmatic), focusing (neutral position), rib cage placement, shoulder placement, head and neck placement (neutral position). Then, Pilates based 'mat' exercises will be performed by the physiotherapist in the clinic for 8 weeks, 2 days / week, 16 sessions. Each session will be programmed to be 45 minutes. During all exercises, including warm-up and cooling, patients will be asked to provide key elements and protect them during movements. Depending on the condition of the patients, the exercises will be advanced from easy to difficult.</description>
    <arm_group_label>behcet group</arm_group_label>
    <arm_group_label>fmf group</arm_group_label>
    <arm_group_label>healty control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being inactive or minimally active according to the International Physical Activity&#xD;
             Survey&#xD;
&#xD;
          -  Being between the ages of 18-65&#xD;
&#xD;
          -  Being diagnosed with FMF at least 1 year ago according to diagnostic criteria&#xD;
&#xD;
          -  A diagnosis of BH at least 1 year ago according to the International Behçet Working&#xD;
             Group&#xD;
&#xD;
          -  Having a cooperative level that can adapt to the evaluation and exercise program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with any central nervous system involvement that may interfere with exercise&#xD;
&#xD;
          -  Those who do not want to participate in the study&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Having other chronic diseases&#xD;
&#xD;
          -  Psychiatric disorders and treated&#xD;
&#xD;
          -  Those with cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IstanbulU</name>
      <address>
        <city>Istanbul</city>
        <state>Bakırköy</state>
        <zip>34740</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Nejla Uzun</investigator_full_name>
    <investigator_title>MSc, Pt</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brucellosis</mesh_term>
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Familial Mediterranean Fever</mesh_term>
    <mesh_term>Hereditary Autoinflammatory Diseases</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/NCT04402255
org study id: 83088843-604.01.04-5578
nct id: NCT04402255
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Behcet's disease (BD) is a chronic systemic inflammatory disease which is characterized by
      oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as
      arthritis, arthralgia, enthesitis and sacroiliitis can be seen in the course of BD. Familial
      Mediterranean fever (FMF) is the most frequent autoinflammatory disease (AID) and
      characterized by selflimited episodes of fever and polyserositis. It is the most common
      monogenic periodic fever syndrome that affects mainly the people of Mediterranean descent.
      Regular physical activity involving aerobic and strengthening programs in inflammatory
      rheumatic diseases has a long-term anti-inflammatory effect. Eccentric exercises cause an
      acute increase in TNF alpha level and should be avoided especially at the beginning. It has
      been stated that patients should be encouraged about aerobic exercise programs where the
      intensity is gradually increased, starting with low intensity. Pilates method is the mind and
      body centering technique developed by Joseph Hubertus Pilates, based on providing lumbopelvic
      stability. FMF and BH have common characteristics such as ethnicity, etiopathogenetic
      mechanisms, symptoms, and treatment. When we look at the literature, there is no study on the
      effectiveness of exercise applications in FMF and Behçet patients. The purpose of our study;
      It is the comparison of the effectiveness of physical activity in patients diagnosed with
      Behçet and FMF and healthy individuals. In this context, with the short form of the
      International Physical Activity Evaluation Questionnaire, Behçet's patients whose physical
      activity level is inactive will be Group 1, FMF patients Group 2 and healthy controls with
      similar demographic characteristics will be Group 3. Pilates based exercise program will be
      applied to all 3 groups for 8 weeks, 2 times a week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: international physical activity questionnaire- short form Web sonuçları International Physical Activity Questionnaire - Short Form
time frame: change from baseline to 8 weeks, follow up at two months
description: This short questionnaire, consisting of seven questions, evaluates the amount of walking done in the last week and the amount of moderate and difficult physical activities performed in work, transportation, housework, gardening and leisure activities.
measure: six minute walk test
time frame: change from baseline to 8 weeks, follow up at two months
description: It is a simple test that measures the distance an individual can walk at a fast pace on a flat, hard floor in 6 minutes.
measure: Biodex balance system (BBS)
time frame: change from baseline to 8 weeks, follow up at two months
description: The BBS has a round foot platform that moves in all planes. It grants 20 degrees of foot platform motion in different directions. The platform has foot angles and heel coordinates for proper foot placement before starting the balance test trial. The foot angles range from 0° to 45° and heel coordinates are expressed as the intersection of letters from A to P and numbers from 1 to 21. The participants were asked to centralize their body while they placed their feet in the most comfortable position and their feet 10 cm apart with eyes open. They were asked to hold the rails in case they felt unbalanced. The machine measured the magnitude of their postural sways: higher scores for postural sway indicate impaired balance, and a lower score indicate excellent balance
measure: Berg Balance Scale (BBS)
time frame: change from baseline to 8 weeks, follow up at two months
description: The BBS is a 14- item balance test recognized as the gold standard tool for assessing balance (higher scores indicate better balance)
measure: Hamilton Depression Scale
time frame: change from baseline to 8 weeks, follow up at two months
description: The scale was prepared as 21 items, but the last four items were not included in the scoring. The total score is determined on 17 items.
measure: Nottingham Health Profile Questionnaire (NHP)
time frame: change from baseline to 8 weeks, follow up at two months
description: NHP were used as research tools. The Nottingham Health Profile Questionnaire was used to measure health problems perceived by the patient and to assess the effect of these problems on daily functioning
arm group label: behcet group
arm group type: Experimental
description: this group includes 16 patients with behçet
arm group label: fmf group
arm group type: Experimental
description: this group includes 16 patients with fmf
arm group label: healty control
arm group type: Active Comparator
description: this group includes 16 healthy control
intervention type: Other
intervention name: pilates exercise
description: The key elements of Pilates during supine, prone, side-lying and standing positions will be taught. These key elements are: breathing (diaphragmatic), focusing (neutral position), rib cage placement, shoulder placement, head and neck placement (neutral position). Then, Pilates based 'mat' exercises will be performed by the physiotherapist in the clinic for 8 weeks, 2 days / week, 16 sessions. Each session will be programmed to be 45 minutes. During all exercises, including warm-up and cooling, patients will be asked to provide key elements and protect them during movements. Depending on the condition of the patients, the exercises will be advanced from easy to difficult.
arm group label: behcet group
arm group label: fmf group
arm group label: healty control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Nejla Uzun
investigator title: MSc, Pt
mesh term: Brucellosis
mesh term: Behcet Syndrome
mesh term: Familial Mediterranean Fever
mesh term: Hereditary Autoinflammatory Diseases
sharing ipd: No