Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients (GONEARS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes Painful Knee Osteoarthritis with presence of osteophytes on radiography At least 1 of the following 3 criteria's: adult >50 years old, morning stiffness <30 minutes, or in the pre-stage surgical (programmed knee prosthesis replacement). Acceptance to participate in the study Patients affiliated to a social security scheme (beneficiary entitled) Exclusion Criteria: Patient under guardianship, or protection of justice. Cognitive impairment Contraindications to Physical Activities Patient in the incapacity to answer the questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with knee arthrosis<br>Painful Knee Osteoarthritis with presence of osteophytes on radiography | Other: Questionnaires<br>* completion of Exercise Adherence Rating Scale (EARS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adherence to physical exercise programs | measured by Exercise Adherence Rating Scale (EARS) | Day 0 | 
| Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS) | measured by Exercise Adherence Rating Scale (EARS) | Day 2 | 
| Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS) | measured by Exercise Adherence Rating Scale (EARS) | Day 45 | 
| Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS) | measured by Exercise Adherence Rating Scale (EARS) | Day 135 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale ) | 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 | Day 0 | 
| knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale ) | 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 | Day 45 | 
| knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale ) | 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 | Day 135 | 
| personal efficacy by means of the questionnaire ASES Arthritis Self-Efficacy Scale | The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy). | Day 0 | 
| personal efficacy by means of the questionnaire ASES Arthritis Self-Efficacy Scale | The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy). | Day 45 | 
| personal efficacy by means of the questionnaire ASES Arthritis Self-Efficacy Scale | The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy). | Day 135 | 
| Patient Global Impression of Change by Scale (PGIC) | 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. | Day 45 | 
| Patient Global Impression of Change by Scale (PGIC) | 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. | Day 135 | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 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 | Day 45 | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 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 | Day 135 | 
| The perceived barriers to and facilitators of physical activity | 5. The perceived barriers to and facilitators of physical activity are measured by EPAP | Day 45 | 
| The perceived barriers to and facilitators of physical activity | 5. The perceived barriers to and facilitators of physical activity are measured by EPAP | Day 135 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Questionnaire, Adhesion, Knee Osteoarthritis