On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Study Overview
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Brief Summary
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Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many on-site health care services are unavailable. This study seeks to investigate the relative effectiveness of an alternative on-line delivery model of exercise and education compared to on-site delivery in patients with knee osteoarthritis.

Detailed Description
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Due to the extraordinary events of the 2020 COVID-19 pandemic, finding alternative delivery-models of treatment has come to the forefront of public health services worldwide. Consequently, on-line treatment is rapidly becoming an integral part of public health service. For patients with knee osteoarthritis (OA), where non-pharmacological and non-surgical treatment is considered first-line treatment, on-line delivered exercise has already shown promise and may be a viable treatment option, especially when traditional on-site exercise delivery models are unavailable. However, further studies are needed to clarify the relative effectiveness of on-line exercise and education when compared to on-site exercise and education programs. This study aims to evaluate the effects of on-line exercise and education in knee OA compared to a cohort of similar knee OA patients completing the same exercise and education program through on-site delivery. This study includes two cohorts of knee OA patients receiving the same exercise and education program through different delivery models (on-line vs. on-site). The on-line cohort is a new treatment delivery initiative, born out of the COVID-19 enforced shutdown of all non-critical on-site health care. The on-site cohort is comprised of knee OA patients from a patient registry, collecting outcome data as part of the exercise and education program. The exercise and education program is called Good Life with osteoArthritis in Denmark (GLA:D), and consists of two to three disease-specific educational sessions and 12 neuromuscular exercise sessions (NEMEX-TJR). GLA:D originates from Denmark and has currently been implemented in Australia, Canada, China, Switzerland and New Zealand. This study will primarily compare outcomes of pain, function and quality of life between the two different treatment delivery models and will provide important insights in effectiveness of alternative delivery models of recommended first-line care for patients with knee OA.

Official Title
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On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: On-line exercise and education
* Other: On-site exercise and education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee OA symptoms resulting in contact with the health care system Exclusion criteria (both study groups): Another reason than OA for the problems; includes tumour or inflammatory joint disease Other symptoms that are more pronounced than the OA symptoms; i.e. chronic, generalised pain or fibromyalgia. In addition, for the on-line study group: Previous participation in similar exercise and education programs (i.e. the on-site version) Lack of necessary equipment or skills to administer on-line participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| On-line exercise and education<br>Exercise (12 sessions) and education (2-3 sessions) delivered on-line. Patients attend both the exercise and educational sessions by logging on to virtual rooms using links sent out by e-mail. The sessions are led and supervised by GLA:D certified physiotherapists. | Other: On-line exercise and education<br>* Exercise: Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. Patients are instructed in how to use alternative equipment at home for each exercise if necessary prior to the first on-line exercise session. Education: Patients attend two to three on-line educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.<br>|
| On-site exercise and education<br>Exercise (12 sessions) and education (2-3 sessions) delivered on-site. Patients attend both the exercise and educational sessions at physiotherapy clinics in Denmark. The sessions are led and supervised by GLA:D certified physiotherapists. | Other: On-site exercise and education<br>* Exercise: Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. The exercise sessions are delivered at physiotherapy clinics in Denmark. Education: Patients attend two to three on-site educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee impact summary | Summary score from the Knee injury and Osteoarthritis Outcome Score, short version (KOOS 12). The summary score is calculated as the average score from the KOOS 12 subscales pain, function and quality of life (QOL), ranging from 0 (worst) to 100 (best). | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fast-paced walking ability | Fast-paced walking ability is recorded by the physiotherapists and evaluated using the 40-m fast-paced walk test. | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months) | 
| Chair-stand ability | Chair-stand ability is recorded by the physiotherapists and evaluated using the 30-s chair-stand test. | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months) | 
| Self-reported function | Patients self-report of function during daily life using the subscale function from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best). | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months | 
| Self-reported pain | Patients self-report of pain using the subscale pain from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best). | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months | 
| Self-reported quality of life | Patients self-report of quality of life using the subscale quality of life from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best). | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months | 
| Pain intensity | Mean pain intensity during the last week in the most affected knee is evaluated on a 100 mm visual analogue scale (VAS) with terminal descriptors of 'no pain' (0 mm) and 'maximum pain' (100 mm). | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months | 
| Physical activity and exercise | Patients self-report of time spent (frequency and duration) on structured physical activity and exercise. | Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Osteoarthritis, Exercise, Education, On-line, Pain, Function, Quality of Life