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Physical Activity Levels During Recovery Following Knee Arthroplasty

2020年7月23日 更新者：University of Oxford

Identifying the Trajectory of Normal Recovery Following Knee Arthroplasty Through Physical Activity Monitoring Via Wrist-Worn Accelerometry

The goal of this study is to utilize physical activity monitoring to determine the trajectory of normal recovery as it relates to a patient's ability to get up and get moving. From this work, we hope to be able to define the range in patients' physical activity following knee replacement surgery, and thus, give clinicians a tool and the methodology to identify patients whose recovery is not progressing as quickly as expected. Data from physical activity monitors will allow the research team to identify how active patients are, how vigorous that activity is, and how well that activity correlates with standard and commonly used patient questionnaires.

研究概览

地位

未知

条件

干预/治疗

详细说明

This study is an observational study of the physical activity levels of adults who have been diagnosed with end-stage osteoarthritis of the knee and are undergoing knee replacement surgery at the Nuffield Orthopaedic Centre, Oxford. Data regarding patient activity and functional recovery will be collected using two methods. First, data will be collected through the extraction of three-axis accelerometer data, collected via a wrist-worn (and hip-worn for a subset of patients) physical activity monitor. This data will be collected in three intervals: pre-operatively, immediately postoperatively, and at 6 months postoperatively. Secondly, data will be collected by standard clinical assessment and patient reported outcome measures. These assessments will again take place pre-operatively, at 6 weeks postoperatively, and at 6 months postoperatively. Additional data will be collected through a simple activity diary, which asks the participants to log their monitor wear-time along with the times that they took bicycle rides or extended walks.

The expected duration of patient involvement is up to a total of 8 to 8.5 weeks over the course of up to 7 months. There are no clinical visits within this protocol beyond what is already within normal patient care. Patients will be asked to post their monitor back to the research centre for data collection and data processing twice during the study period.

The aim of this study is to assess the trajectory of recovery in terms of physical activity in the post-operative knee replacement population, and subsequently to define the expected path of early recovery.

研究类型

观察性的

注册 (预期的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 英国
    • Oxfordshire
      • Oxford、Oxfordshire、英国、OX3 7LD
        • 招聘中
        • Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
        • 接触：
        • 首席研究员：
          • Andrew J Price, DPhil, FRCS
        • 副研究员：
          • Scott R Small, MS
        • 副研究员：
          • Karen L Barker, PhD, FCSP
        • 副研究员：
          • Sara Khalid, DPhil

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants will be patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.

描述

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with required late stage osteoarthritis, undergoing knee arthroplasty in the next 3 months.
  • In Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Participants who are enrolled in another research study involving an investigational product or methodology that could alter physical activity.
  • Participants are undergoing a revision arthroplasty surgery on the operative knee

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Knee Arthroplasty Patient
Patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
设备：Total or Partial Knee Arthroplasty
Reconstruction of part or all of the native articulation at the knee joint via implant.
其他名称：
  • Knee Replacement

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in physical activity
大体时间：Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.
The primary outcome measure will physical activity, as extracted from analysis of raw accelerometer data from the activity monitor. Several variables will be extracted from the raw data, including average acceleration vector (Euclidean norm minus one), bouts of physical activity and percentage of active and sedentary time.
Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.

次要结果测量

结果测量
措施说明
大体时间
Change in Oxford Knee Score
大体时间：Pre-operative (baseline), 6 weeks, 6 months
A patient reported outcome measure to assess patient benefit [Range 0 to 48, higher scores corresponding to better outcomes].
Pre-operative (baseline), 6 weeks, 6 months
Change in EQ-5D-5L
大体时间：Pre-operative (baseline), 6 weeks, 6 months
A patient reported outcome measure to assess patient benefit. As summary index score from 0 to 1 is given, where 0 is the health state equivalent to dead, 1 is a full healthy outcome, and negative indicates a health state worse than dead. The score is derived from five sections (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression) scored 1 to 5, with higher corresponding to better outcomes. A second visual analogue score for perceived health is reported from 0 to 100 with higher scores indicating better perceived overall health.
Pre-operative (baseline), 6 weeks, 6 months
Change in University of California, Los Angeles (UCLA) Activity Score
大体时间：Pre-operative (baseline), 6 weeks, 6 months
A self-reported score to assess patient benefit and physical activity. The score ranges from 1 to 10 where higher scores indicate greater levels of physical activity
Pre-operative (baseline), 6 weeks, 6 months
Change in International Physical Activity Questionnaire Questionnaire - Short Form
大体时间：Pre-operative (baseline), 6 weeks, 6 months
A self-reported score to assess patient benefit and physical activity. The score can be reported in one of three categories: Low, Moderate, or High physical activity.
Pre-operative (baseline), 6 weeks, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Oxford

调查人员

  • 首席研究员：Scott R Small, MS、University of Oxford

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月31日

初级完成 (预期的)

2021年6月1日

研究完成 (预期的)

2021年10月1日

研究注册日期

首次提交

2020年1月22日

首先提交符合 QC 标准的

2020年1月22日

首次发布 (实际的)

2020年1月27日

研究记录更新

最后更新发布 (实际的)

2020年7月27日

上次提交的符合 QC 标准的更新

2020年7月23日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • IRAS 260855
  • 19/SW/0151 (其他标识符：NHS Health Research Authority)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD 共享时间框架

Data will be made available within 6 months following study completion.

IPD 共享访问标准

Data access requests will be reviewed by the trial steering committee.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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