On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437134
• Other study ID #: SlagelseH
• Secondary ID: J.nr. 20-000013
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: June 14, 2022

Study information

• Verified date: April 2023
• Source: Slagelse Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3789
• Est. completion date: June 14, 2022
• Est. primary completion date: July 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• On-line exercise and education
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.
• On-site exercise and education
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.

Locations

Country	Name	City	State
Denmark	Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals	Næstved	Region Zealand
Denmark	Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals	Næstved	Region Zealand
Denmark	University of Southern Denmark	Odense	Region Southern Denmark
Denmark	Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals	Slagelse	Region Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Slagelse Hospital	Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Patients self-report of satisfaction with the GLA:D program.	Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Other	Continuation of exercise	Patients self-reporting if, how and where they have continued exercising.	Follow-up point: 12 months
Other	Self-reported activity levels	Patients self-report their current activity levels using the University of California, Los Angeles (UCLA) activity scale, ranging from 1 (inactive, dependent on others) to 10 (regular participation in high-impact sports).	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	Usage of what was learned during GLA:D	Patients self-report of use of acquired skills and knowledge from the GLA:D program.	Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Other	Symptom management	Patients self-report of how they handle flare-ups in their knee OA symptoms.	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	Intake of pain killers	Intake of painkillers is evaluated by the physiotherapist asking the patients about intake of any joint related medication. If taking painkillers, the patients are asked which type and whether or not they were taken because of their knee pain.	Primary follow-up: Change from baseline to completion of GLA:D program (an average of three months).
Other	Sick leave	Patients self-report of sick leave due to knee symptoms.	Follow-up points: Baseline and 12 months
Other	Health-related quality of life, index score	Patients self-report of their health situation using EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) score (-0.624 to 1; worst to 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
Other	Health-related quality of life, visual analogue scale	Patients self-report of their health situation using the EuroQol visual analogue scale (EQ VAS), ranging from 0-100 (worst to 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
Other	Global perceived effect	Patients self-report of current knee condition compared to before participation in GLA:D, scored on a 7-point likert scale (much worse to much better).	Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Other	Pain during exercise (only for on-line group)	Patients self-report of pain during each exercise session, rated using a numeric pain rating scale (NPRS) 0-10, with zero representing no pain and 10 representing extreme pain.	Immediately prior to, and immediately after each exercise session
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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