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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Oxfordshire
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Oxford, Oxfordshire, 영국, OX3 7LD
- 모병
- Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
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연락하다:
- Gail Lang
- 이메일: gail.lang@ndorms.ox.ac.uk
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수석 연구원:
- Andrew J Price, DPhil, FRCS
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부수사관:
- Scott R Small, MS
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부수사관:
- Karen L Barker, PhD, FCSP
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부수사관:
- Sara Khalid, DPhil
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in physical activity
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Oxford Knee Score
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Scott R Small, MS, University of Oxford
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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