Viewing Study NCT04437134


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Study NCT ID: NCT04437134
Status: COMPLETED
Last Update Posted: 2023-04-12
First Post: 2020-06-07
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
Sponsor: Slagelse Hospital
Organization:

Study Overview

Official Title: On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
Status: COMPLETED
Status Verified Date: 2023-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
J.nr. 20-000013 OTHER Scientific Ethics Committee of Region Zealand View