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

February 11, 2022 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Painful Knee Osteoarthritis with presence of osteophytes on radiography

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with knee arthrosis
Painful Knee Osteoarthritis with presence of osteophytes on radiography
completion of Exercise Adherence Rating Scale (EARS)

What is the study measuring?

Primary Outcome Measures

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

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 )
Time Frame: Day 45

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 )
Time Frame: Day 135

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"
Time Frame: Day 0
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"
Time Frame: Day 45
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"
Time Frame: Day 135
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)
Time Frame: Day 45

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)
Time Frame: Day 135

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)
Time Frame: Day 45
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)
Time Frame: Day 135
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
Time Frame: Day 45
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
Time Frame: Day 135
5. The perceived barriers to and facilitators of physical activity are measured by EPAP
Day 135

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2019

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RNI 2019 COUDEYRE 2
  • 2019-A01680-57 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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