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临床试验/NCT04437134
NCT04437134已完成不适用

On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Slagelse Hospital3 个研究点 分布在 1 个国家目标入组 3,789 人开始时间: 2020年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,789
试验地点
3
主要终点
Knee impact summary

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Knee impact summary

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Slagelse Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pætur Mikal Holm

Physiotherapist, PhD, Postdoc.

Slagelse Hospital

研究点 (3)

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