Knee OsteoarthritisGONEARSNCT04465331
Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients (GONEARS)
An observational study of Knee Osteoarthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Questionnaires
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2019to 10 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Painful Knee Osteoarthritis with presence of osteophytes on radiography
Who may be able to join
- 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)
Who cannot join
- Patient under guardianship, or protection of justice.
- Cognitive impairment
- Contraindications to Physical Activities
- Patient in the incapacity to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Questionnaires
- Keywords
- Knee Osteoarthritis, Physical activity, Questionnaire, Adhesion
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
completion of Exercise Adherence Rating Scale (EARS)
| Study group | Role | What they receive |
|---|---|---|
| patients with knee arthrosis | Painful Knee Osteoarthritis with presence of osteophytes on radiography Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adherence to physical exercise programs
measured by Exercise Adherence Rating Scale (EARS)
Measured: Day 0
Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
measured by Exercise Adherence Rating Scale (EARS)
Measured: Day 2
Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
measured by Exercise Adherence Rating Scale (EARS)
Measured: Day 45
Assessment of adherence to physical exercise programs measured by Exercise Adherence Rating Scale (EARS)
measured by Exercise Adherence Rating Scale (EARS)
Measured: Day 135
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 135
The perceived barriers to and facilitators of physical activity
- The perceived barriers to and facilitators of physical activity are measured by EPAP
Measured: Day 45
The perceived barriers to and facilitators of physical activity
- The perceived barriers to and facilitators of physical activity are measured by EPAP
Measured: Day 135
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start30 Dec 2019
- Primary completion30 Oct 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Coudeyre, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465331
- Sponsor's protocol ID
- RNI 2019 COUDEYRE 2
- Other IDs
- 2019-A01680-57
- Acronym
- GONEARS
- Status last verified
- Feb 2022
- First submitted
- 7 Jul 2020
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT04465331
- Acronym / sponsor ID
- GONEARS / RNI 2019 COUDEYRE 2
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Physical activity, Questionnaire, Adhesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with knee arthrosis | – | Other: QuestionnairesPainful Knee Osteoarthritis with presence of osteophytes on radiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Painful Knee Osteoarthritis with presence of osteophytes on radiography
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Patient under guardianship, or protection of justice.
- Cognitive impairment
- Contraindications to Physical Activities
- Patient in the incapacity to answer the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairescompletion of Exercise Adherence Rating Scale (EARS) | Other | patients with knee arthrosis |
Primary outcome
Assessment of adherence to physical exercise programs
Time frame: Day 0
measured by Exercise Adherence Rating Scale (EARS)
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)
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)
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)
12 secondary outcomes
knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
Time frame: Day 0
knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
Time frame: Day 45
knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression Scale )
Time frame: Day 135
personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
Time frame: Day 0
personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
Time frame: Day 45
personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
Time frame: Day 135
Patient Global Impression of Change by Scale (PGIC)
Time frame: Day 45
Patient Global Impression of Change by Scale (PGIC)
Time frame: Day 135
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Day 45
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Day 135
The perceived barriers to and facilitators of physical activity
Time frame: Day 45
The perceived barriers to and facilitators of physical activity
Time frame: Day 135
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Coudeyre principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adherence to physical exercise programs (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.