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/NCT06034665</url>
    </required_header>
    <id_info>
      <org_study_id>DR2022</org_study_id>
      <nct_id>NCT06034665</nct_id>
    </id_info>
    <brief_title>Estimation of the MCID for Patients With Knee Osteoarthritis</brief_title>
    <official_title>Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis</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>Yes</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>
        Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with&#xD;
        patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these&#xD;
        scales are needed to understand the change in patients after treatment and to manage the&#xD;
        treatment.&#xD;
  &#xD;
        It is also one of the most important data in calculating the MCID sample size. Aim: In the&#xD;
        literature, MCID studies for exercise applied to knee OA are limited especially for those who&#xD;
        did not undergo surgery. Thus new studies are needed.&#xD;
  &#xD;
        Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the&#xD;
        study. Participants will be included in an exercise program tailored to their needs for 15&#xD;
        sessions. WOMAC, KOOS, LEFS scales will be used also knee range of motion will be assessed in&#xD;
        the baseline, after treatments, in the 4th and 6th months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>WOMAC</measure>
      <time_frame>Baseline, after 15 session and 4 months follow up</time_frame>
      <description>Western Ontario and McMaster Universities Osteoarthritis Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>KOOS</measure>
      <time_frame>Baseline, after 15 session and 4 months follow up</time_frame>
      <description>Knee Injury and Osteoarthritis Outcome Score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>LEFS</measure>
      <time_frame>Baseline, after 15 session and 4 months follow up</time_frame>
      <description>Lower Extremity Functional Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee Range of Motion</measure>
      <time_frame>Baseline, after 15 session and 4 months follow up</time_frame>
      <description>Range of motion assessment with goniometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>30s sit to stand test</measure>
      <time_frame>Baseline, after 15 session and 4 months follow up</time_frame>
      <description>For functional assessment, patient sit and stand for 30 seconds</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Exercise</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients will receive an exercise rehabilitation program tailored to their needs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.</description>
      <arm_group_label>Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be diagnosed with knee OA according to the criteria of the American Society of&#xD;
               Rheumatology (ACR) (Diagnosis of primary knee OA)&#xD;
  &#xD;
            -  Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria&#xD;
  &#xD;
            -  Participants with age between 50 and 70 years old&#xD;
  &#xD;
            -  Being able to walk without using an assistive device&#xD;
  &#xD;
            -  Having a body mass index of less than 30 kg/m²&#xD;
  &#xD;
            -  Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who received physical therapy or intra-articular injections in the last 6&#xD;
               months&#xD;
  &#xD;
            -  Receiving an indication for surgery&#xD;
  &#xD;
            -  Have severe hearing, vision and speech impairment&#xD;
  &#xD;
            -  Having serious systemic and cardiovascular diseases that interfere with exercise&#xD;
  &#xD;
            -  Having a lower extremity deformity&#xD;
  &#xD;
            -  Patients with acute inflammation of the knee&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Istinye University Physiotherapy and Rehabilitation Application and Research Center</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University</investigator_affiliation>
      <investigator_full_name>Derya Celik</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>knee osteoarthritis</keyword>
    <keyword>mcid</keyword>
    <keyword>exercise</keyword>
    <keyword>rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</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/NCT06034665
  org study id: DR2022
  nct id: NCT06034665
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with
        patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these
        scales are needed to understand the change in patients after treatment and to manage the
        treatment.
  
        It is also one of the most important data in calculating the MCID sample size. Aim: In the
        literature, MCID studies for exercise applied to knee OA are limited especially for those who
        did not undergo surgery. Thus new studies are needed.
  
        Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the
        study. Participants will be included in an exercise program tailored to their needs for 15
        sessions. WOMAC, KOOS, LEFS scales will be used also knee range of motion will be assessed in
        the baseline, after treatments, in the 4th and 6th months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: WOMAC
  time frame: Baseline, after 15 session and 4 months follow up
  description: Western Ontario and McMaster Universities Osteoarthritis Index
  measure: KOOS
  time frame: Baseline, after 15 session and 4 months follow up
  description: Knee Injury and Osteoarthritis Outcome Score
  measure: LEFS
  time frame: Baseline, after 15 session and 4 months follow up
  description: Lower Extremity Functional Scale
  measure: Knee Range of Motion
  time frame: Baseline, after 15 session and 4 months follow up
  description: Range of motion assessment with goniometer
  measure: 30s sit to stand test
  time frame: Baseline, after 15 session and 4 months follow up
  description: For functional assessment, patient sit and stand for 30 seconds
  arm group label: Exercise
  arm group type: Other
  description: All patients will receive an exercise rehabilitation program tailored to their needs.
  intervention type: Other
  intervention name: Exercise
  description: All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.
  arm group label: Exercise
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University
  investigator full name: Derya Celik
  investigator title: Professor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No