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Clinical Trials/NCT04437134
NCT04437134
Completed
Not Applicable

On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Slagelse Hospital3 sites in 1 country3,789 target enrollmentJune 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Slagelse Hospital
Enrollment
3789
Locations
3
Primary Endpoint
Knee impact summary
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2020
End Date
June 14, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Slagelse Hospital
Responsible Party
Principal Investigator
Principal Investigator

Pætur Mikal Holm

Physiotherapist, PhD, Postdoc.

Slagelse Hospital

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Knee impact summary

Time Frame: 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 Outcomes

  • Fast-paced walking ability(Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months))
  • 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)
  • Chair-stand ability(Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months))
  • 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)
  • 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)
  • 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)
  • 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)

Study Sites (3)

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