Clinical trial NCT04465331: Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients (GONEARS)
Official title: Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Physical activity
Questionnaire
Adhesion
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Painful Knee Osteoarthritis with presence of osteophytes on radiography

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of adherence to physical exercise programs
timeFrame: Day 0
measure: Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
timeFrame: Day 2
measure: Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
timeFrame: Day 45
measure: Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
timeFrame: Day 135
Secondary outcomes:
measure: knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
timeFrame: Day 0
measure: knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
timeFrame: Day 45
measure: knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
timeFrame: Day 135
measure: personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
timeFrame: Day 0
measure: personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
timeFrame: Day 45
measure: personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
timeFrame: Day 135
measure: Patient Global Impression of Change by Scale (PGIC)
timeFrame: Day 45
measure: Patient Global Impression of Change by Scale (PGIC)
timeFrame: Day 135
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Day 45
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Day 135
measure: The perceived barriers to and facilitators of physical activity
timeFrame: Day 45
measure: The perceived barriers to and facilitators of physical activity
timeFrame: Day 135
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel Coudeyre
role: PRINCIPAL_INVESTIGATOR
References: