Skip to main content
OpenTrials
Completed

NCT Number: NCT04465331

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Cicatrix Fibrosis Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Tissue Adhesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

completion of Exercise Adherence Rating Scale (EARS)

Primary outcomes

  1. Assessment of adherence to physical exercise programs

    Time frame: Day 0

    measured by Exercise Adherence Rating Scale (EARS)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. The perceived barriers to and facilitators of physical activity

    Time frame: Day 45

    • The perceived barriers to and facilitators of physical activity are measured by EPAP

  12. The perceived barriers to and facilitators of physical activity

    Time frame: Day 135

    • The perceived barriers to and facilitators of physical activity are measured by EPAP

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: GONEARS

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 10, 2020
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.