On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Other: On-line exercise and educationOther: On-site exercise and education
- Registration Number
- NCT04437134
- Lead Sponsor
- Slagelse Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3789
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description On-line exercise and education On-line exercise and education 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. On-site exercise and education On-site exercise and education 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.
- Primary Outcome Measures
Name Time Method Knee impact summary Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months 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).
- Secondary Outcome Measures
Name Time Method Fast-paced walking ability Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months) Fast-paced walking ability is recorded by the physiotherapists and evaluated using the 40-m fast-paced walk test.
Self-reported function Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months 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).
Chair-stand ability Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months) Chair-stand ability is recorded by the physiotherapists and evaluated using the 30-s chair-stand test.
Self-reported pain Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months Patients self-report of pain using the subscale pain from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).
Self-reported quality of life Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months 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).
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 Patients self-report of time spent (frequency and duration) on structured physical activity and exercise.
Pain intensity Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months 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).
Trial Locations
- Locations (3)
Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals
🇩🇰Næstved, Region Zealand, Denmark
Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals
🇩🇰Slagelse, Region Zealand, Denmark
University of Southern Denmark
🇩🇰Odense, Region Southern Denmark, Denmark