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

NCT04465331 | Completed

• 2 other identifiers: RNI 2019 COUDEYRE 22019-A01680-57
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Physical activity; Questionnaire; Adhesion

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )

  Day 0

• knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )

  Day 45

• knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )

  Day 135

• personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"

  Day 0

• personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"

  Day 45

Study Arms (1)

patients with knee arthrosis

Painful Knee Osteoarthritis with presence of osteophytes on radiography

Other: Questionnaires

Interventions

Questionnaires OTHER

completion of Exercise Adherence Rating Scale (EARS)

patients with knee arthrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Painful Knee Osteoarthritis with presence of osteophytes on radiography

You may qualify if:

• 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)

You may not qualify if:

• Patient under guardianship, or protection of justice.
• Cognitive impairment
• Contraindications to Physical Activities
• Patient in the incapacity to answer the questionnaire

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Tissue Adhesions

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emmanuel Coudeyre

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: December 30, 2019
• Primary Completion: October 30, 2021
• Study Completion: February 10, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

FR (1)