Physical Activity Levels During Recovery Following Knee Arthroplasty
Identifying the Trajectory of Normal Recovery Following Knee Arthroplasty Through Physical Activity Monitoring Via Wrist-Worn Accelerometry
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
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Oxfordshire
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Oxford、Oxfordshire、イギリス、OX3 7LD
- 募集
- Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
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コンタクト：
- Gail Lang
- メール：gail.lang@ndorms.ox.ac.uk
-
主任研究者：
- Andrew J Price, DPhil, FRCS
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副調査官：
- Scott R Small, MS
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副調査官：
- Karen L Barker, PhD, FCSP
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副調査官：
- Sara Khalid, DPhil
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Knee Arthroplasty Patient
Patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
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Reconstruction of part or all of the native articulation at the knee joint via implant.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in physical activity
時間枠：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.
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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.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Oxford Knee Score
時間枠：Pre-operative (baseline), 6 weeks, 6 months
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A patient reported outcome measure to assess patient benefit [Range 0 to 48, higher scores corresponding to better outcomes].
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Pre-operative (baseline), 6 weeks, 6 months
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Change in EQ-5D-5L
時間枠：Pre-operative (baseline), 6 weeks, 6 months
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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.
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Pre-operative (baseline), 6 weeks, 6 months
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Change in University of California, Los Angeles (UCLA) Activity Score
時間枠：Pre-operative (baseline), 6 weeks, 6 months
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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
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Pre-operative (baseline), 6 weeks, 6 months
|
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Change in International Physical Activity Questionnaire Questionnaire - Short Form
時間枠：Pre-operative (baseline), 6 weeks, 6 months
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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.
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Pre-operative (baseline), 6 weeks, 6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Scott R Small, MS、University of Oxford
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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