<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/NCT04465331</url>
  </required_header>
  <id_info>
    <org_study_id>RNI 2019 COUDEYRE 2</org_study_id>
    <secondary_id>2019-A01680-57</secondary_id>
    <nct_id>NCT04465331</nct_id>
  </id_info>
  <brief_title>Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients (GONEARS)</brief_title>
  <acronym>GONEARS</acronym>
  <official_title>Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      The origin of knee osteoarthritis is multifactorial but the disease is strongly related to&#xD;
      age. The pain and functional disability are the main reasons for consultation.&#xD;
      Non-pharmaceutical treatment is always indicated.&#xD;
&#xD;
      The rehabilitation will reduce the pain, maintain or partially recover the amplitude of the&#xD;
      movements as well as fight against vicious analgesic attitudes and strengthen the muscles to&#xD;
      stabilize the joints. A program of self-rehabilitation exercises performed at home may be&#xD;
      prescribed to people with knee osteoarthritis. It must include exercises adapted to the&#xD;
      patient's functional abilities and painful level and requires education to improve the&#xD;
      patient's motivation to practice a regular exercise program. However, adherence to such&#xD;
      exercises is low, and until 2016 there was no objective way to find out the reasons for&#xD;
      patients' lack of adherence to self-workout programs. The EARS (&quot;Exercise Adherence Rating&#xD;
      Scale&quot; or Adhesion to Physical Exercise Programs) is validated in 2016 and reliable to&#xD;
      evaluate the physical activity of patients with low back pain.&#xD;
&#xD;
      As far as we know, this questionnaire is the only one validated in the international&#xD;
      literature, a validation for French patients is currently underway. We believe this tool can&#xD;
      be used for patients with knee osteoarthritis after minor changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EARS (&quot;Exercise Adherence Rating Scale&quot; or Adhesion to Physical Exercise Programs) assesses&#xD;
      in the first part what type of physical exercise was recommended for patients with common&#xD;
      chronic pain, as well as their frequencies and the date until which they were prescribed. The&#xD;
      patient can also inform how often he can do his exercises, or otherwise, if he has completely&#xD;
      stopped them, to mention since when and why.&#xD;
&#xD;
      A second part of the questionnaire explores the behavior of patients towards adherence to&#xD;
      exercise programs and a final part examines the reasons for or not performing these&#xD;
      exercises.&#xD;
&#xD;
      Inclusion and the first questionnaires period at the beginning of the knee rehabilitation&#xD;
      program (program for 6 weeks). Clinical and demographic data questionnaire that will be&#xD;
      completed by the investigating physician. The second questionnaire will be done at 48 hours&#xD;
      from the inclusion (only the EARS questionnaire will be filled at 2 days). The third time the&#xD;
      patients will complete the questionnaires at the end of the rehabilitation program and the&#xD;
      last time at 4 months end half.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2019</start_date>
  <completion_date type="Actual">February 10, 2022</completion_date>
  <primary_completion_date type="Actual">October 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of adherence to physical exercise programs</measure>
    <time_frame>Day 0</time_frame>
    <description>measured by Exercise Adherence Rating Scale (EARS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)</measure>
    <time_frame>Day 2</time_frame>
    <description>measured by Exercise Adherence Rating Scale (EARS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)</measure>
    <time_frame>Day 45</time_frame>
    <description>measured by Exercise Adherence Rating Scale (EARS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)</measure>
    <time_frame>Day 135</time_frame>
    <description>measured by Exercise Adherence Rating Scale (EARS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )</measure>
    <time_frame>Day 0</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.&#xD;
One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.&#xD;
Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )</measure>
    <time_frame>Day 45</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.&#xD;
One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.&#xD;
Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )</measure>
    <time_frame>Day 135</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.&#xD;
One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.&#xD;
Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>personal efficacy by means of the questionnaire ASES &quot;Arthritis Self-Efficacy Scale&quot;</measure>
    <time_frame>Day 0</time_frame>
    <description>The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>personal efficacy by means of the questionnaire ASES &quot;Arthritis Self-Efficacy Scale&quot;</measure>
    <time_frame>Day 45</time_frame>
    <description>The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>personal efficacy by means of the questionnaire ASES &quot;Arthritis Self-Efficacy Scale&quot;</measure>
    <time_frame>Day 135</time_frame>
    <description>The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change by Scale (PGIC)</measure>
    <time_frame>Day 45</time_frame>
    <description>This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item.&#xD;
Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change by Scale (PGIC)</measure>
    <time_frame>Day 135</time_frame>
    <description>This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item.&#xD;
Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Day 45</time_frame>
    <description>This scale evaluates all aspects the patients' opinion (symptoms, functional disability in activities of daily life or sports activities, quality of life) about their knee and hip problems, both for traumatic and degenerative joint diseases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Day 135</time_frame>
    <description>This scale evaluates all aspects the patients' opinion (symptoms, functional disability in activities of daily life or sports activities, quality of life) about their knee and hip problems, both for traumatic and degenerative joint diseases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The perceived barriers to and facilitators of physical activity</measure>
    <time_frame>Day 45</time_frame>
    <description>5. The perceived barriers to and facilitators of physical activity are measured by EPAP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The perceived barriers to and facilitators of physical activity</measure>
    <time_frame>Day 135</time_frame>
    <description>5. The perceived barriers to and facilitators of physical activity are measured by EPAP</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>patients with knee arthrosis</arm_group_label>
    <description>Painful Knee Osteoarthritis with presence of osteophytes on radiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>completion of Exercise Adherence Rating Scale (EARS)</description>
    <arm_group_label>patients with knee arthrosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Painful Knee Osteoarthritis with presence of osteophytes on radiography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  Painful Knee Osteoarthritis with presence of osteophytes on radiography&#xD;
&#xD;
          -  At least 1 of the following 3 criteria's: adult &gt;50 years old, morning stiffness &lt;30&#xD;
             minutes, or in the pre-stage surgical (programmed knee prosthesis replacement).&#xD;
&#xD;
          -  Acceptance to participate in the study&#xD;
&#xD;
          -  Patients affiliated to a social security scheme (beneficiary entitled)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under guardianship, or protection of justice.&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Contraindications to Physical Activities&#xD;
&#xD;
          -  Patient in the incapacity to answer the questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel Coudeyre</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>February 11, 2022</last_update_submitted>
  <last_update_submitted_qc>February 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee Osteoarthritis</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Questionnaire</keyword>
  <keyword>Adhesion</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>
  <!-- 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/NCT04465331
org study id: RNI 2019 COUDEYRE 2
secondary id: 2019-A01680-57
nct id: NCT04465331
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The origin of knee osteoarthritis is multifactorial but the disease is strongly related to
      age. The pain and functional disability are the main reasons for consultation.
      Non-pharmaceutical treatment is always indicated.

      The rehabilitation will reduce the pain, maintain or partially recover the amplitude of the
      movements as well as fight against vicious analgesic attitudes and strengthen the muscles to
      stabilize the joints. A program of self-rehabilitation exercises performed at home may be
      prescribed to people with knee osteoarthritis. It must include exercises adapted to the
      patient's functional abilities and painful level and requires education to improve the
      patient's motivation to practice a regular exercise program. However, adherence to such
      exercises is low, and until 2016 there was no objective way to find out the reasons for
      patients' lack of adherence to self-workout programs. The EARS ("Exercise Adherence Rating
      Scale" or Adhesion to Physical Exercise Programs) is validated in 2016 and reliable to
      evaluate the physical activity of patients with low back pain.

      As far as we know, this questionnaire is the only one validated in the international
      literature, a validation for French patients is currently underway. We believe this tool can
      be used for patients with knee osteoarthritis after minor changes.
EARS ("Exercise Adherence Rating Scale" or Adhesion to Physical Exercise Programs) assesses
      in the first part what type of physical exercise was recommended for patients with common
      chronic pain, as well as their frequencies and the date until which they were prescribed. The
      patient can also inform how often he can do his exercises, or otherwise, if he has completely
      stopped them, to mention since when and why.

      A second part of the questionnaire explores the behavior of patients towards adherence to
      exercise programs and a final part examines the reasons for or not performing these
      exercises.

      Inclusion and the first questionnaires period at the beginning of the knee rehabilitation
      program (program for 6 weeks). Clinical and demographic data questionnaire that will be
      completed by the investigating physician. The second questionnaire will be done at 48 hours
      from the inclusion (only the EARS questionnaire will be filled at 2 days). The third time the
      patients will complete the questionnaires at the end of the rehabilitation program and the
      last time at 4 months end half.
observational model: Cohort
time perspective: Prospective
measure: Assessment of adherence to physical exercise programs
time frame: Day 0
description: measured by Exercise Adherence Rating Scale (EARS)
measure: Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
time frame: Day 2
description: measured by Exercise Adherence Rating Scale (EARS)
measure: Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
time frame: Day 45
description: measured by Exercise Adherence Rating Scale (EARS)
measure: Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
time frame: Day 135
description: measured by Exercise Adherence Rating Scale (EARS)
measure: knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
time frame: Day 0
description: The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.
One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal
measure: knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
time frame: Day 45
description: The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.
One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal
measure: knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
time frame: Day 135
description: The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.
One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal
measure: personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
time frame: Day 0
description: The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).
measure: personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
time frame: Day 45
description: The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).
measure: personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
time frame: Day 135
description: The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).
measure: Patient Global Impression of Change by Scale (PGIC)
time frame: Day 45
description: This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item.
Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.
measure: Patient Global Impression of Change by Scale (PGIC)
time frame: Day 135
description: This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item.
Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: Day 45
description: This scale evaluates all aspects the patients' opinion (symptoms, functional disability in activities of daily life or sports activities, quality of life) about their knee and hip problems, both for traumatic and degenerative joint diseases
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: Day 135
description: This scale evaluates all aspects the patients' opinion (symptoms, functional disability in activities of daily life or sports activities, quality of life) about their knee and hip problems, both for traumatic and degenerative joint diseases
measure: The perceived barriers to and facilitators of physical activity
time frame: Day 45
description: 5. The perceived barriers to and facilitators of physical activity are measured by EPAP
measure: The perceived barriers to and facilitators of physical activity
time frame: Day 135
description: 5. The perceived barriers to and facilitators of physical activity are measured by EPAP
arm group label: patients with knee arthrosis
description: Painful Knee Osteoarthritis with presence of osteophytes on radiography
intervention type: Other
intervention name: Questionnaires
description: completion of Exercise Adherence Rating Scale (EARS)
arm group label: patients with knee arthrosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel Coudeyre
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee