Clinical trial NCT04437134: On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
Official title: On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Exercise
Education
On-line
Pain
Function
Quality of Life
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: Region Zealand
First posted: 2020-06-18
Enrollment: 3789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included into this study are adults, reporting knee OA symptoms as their main source of pain.

Both study groups (on-line and on-site exercise and education) are comprised of patients with symptomatically verified (all) and radiographically verified (most) knee OA.

On-line exercise and education:

Patients referred for assessment in secondary care due to knee OA symptoms.

On-site exercise and education:

Patients with knee OA symptoms referred to a physiotherapist either by their general practitioner, by an orthopedic surgeon, or by self-referral.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee impact summary
timeFrame: 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 outcomes:
measure: Fast-paced walking ability
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
measure: Chair-stand ability
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
measure: Self-reported function
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Self-reported pain
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Self-reported quality of life
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Pain intensity
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Physical activity and exercise
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Other outcomes:
measure: Patient satisfaction
timeFrame: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Continuation of exercise
timeFrame: Follow-up point: 12 months
measure: Self-reported activity levels
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Usage of what was learned during GLA:D
timeFrame: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Symptom management
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Intake of pain killers
timeFrame: Primary follow-up: Change from baseline to completion of GLA:D program (an average of three months).
measure: Sick leave
timeFrame: Follow-up points: Baseline and 12 months
measure: Health-related quality of life, index score
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Health-related quality of life, visual analogue scale
timeFrame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Global perceived effect
timeFrame: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
measure: Pain during exercise (only for on-line group)
timeFrame: Immediately prior to, and immediately after each exercise session
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Region Southern Denmark
city: Næstved
country: Denmark
facility: Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals
state: Region Zealand
city: Næstved
country: Denmark
facility: Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals
state: Region Zealand
city: Slagelse
country: Denmark
facility: Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals
state: Region Zealand
Study officials:
affiliation: Department of Physiotherapy and Occupational Therapy
name: Pætur M Holm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physiotherapy and occupational Therapy
name: Søren T Skou, Professor
role: STUDY_CHAIR
References: