On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

NCT ID: NCT04437134

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3789 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2022-06-14

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.

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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-line exercise and education

Intervention Type: OTHER

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 (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.

On-site exercise and education

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Knee OA symptoms resulting in contact with the health care system

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Zealand

OTHER

Sponsor Role: collaborator

Slagelse Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pætur Mikal Holm

Physiotherapist, PhD, Postdoc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pætur M Holm, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy and Occupational Therapy

Søren T Skou, Professor

Role: STUDY_CHAIR

Department of Physiotherapy and occupational Therapy

Locations

Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals

Næstved, Region Sjælland, Denmark

Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals

Næstved, Region Sjælland, Denmark

Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals

Slagelse, Region Sjælland, Denmark

University of Southern Denmark

Odense, Region Southern Denmark, Denmark

Countries

Denmark

Other Identifiers

J.nr. 20-000013

Identifier Type: OTHER

Identifier Source: secondary_id

SlagelseH

Identifier Type: -

Identifier Source: org_study_id