Evaluating the Clinical Impact of the Prehabilitation and Recovery for Enabling Potential (PREP) Clinical Care Pathway
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical impact using the Oxford Knee Score
研究概览
简要总结
The Evaluating PREP Study aims to determine in whether the PREP Programme has an impact on clinical outcomes for Veterans undergoing TKR. Specifically, we are exploring whether prehabilitation and a week long intense individualised rehabilitation period after TKR surgery has a positive impact on functional and mental outcomes, and whether these are sustained for up to 12 months post-surgery.
详细描述
There is compelling clinical, methodological, and service-level rationale to implement and evaluate a veteran-specific prehabilitation and rehabilitation pathway. This proposed service, The Prehabilitation and Recovery for Enabling Potential (PREP) Programme, incorporates standardized outcome measures aligned with core domains for Total Knee Replacement (TKR), and addresses the biopsychosocial complexity unique to veteran populations. The PREP Programme aims not only to improve patient-level outcomes but also to contribute meaningful data to an underrepresented area of Orthopaedic rehabilitation research.
The Evaluating PREP Research Study aims to determine in real-time whether the PREP Programme has an impact on clinical outcomes for Veterans undergoing TKR, and whether these are sustained for up to 12 months post-surgery.
The research study plans to collect data from people undergoing the PREP Programme by extracting clinical data as they move through the clinical prehabilitation and rehabilitation programme. The study will also collect data from an additional questionnaire.
Understanding whether individualised prehabilitation prior to TKR and intensive rehabilitation following surgery influences both physical and mental outcomes for Veteran patients could help improve surgical management in the future, leading to better outcomes for this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Must be a Veteran under the clinical care of an RJAH Veterans Orthopaedic Consultant and participating in the PREP Programme.
- •Able to read and speak English.
- •Able to demonstrate capacity to provide informed consent.
排除标准
- •Subject is under 18 years of age.
- •Subject is not a Veteran, not under the care of an RJAH Veteran's Orthopaedic Consultant, or is not participating in the PREP Programme.
- •Unable to read and speak English.
- •Unable to demonstrate capacity to provide informed consent.
- •Unable, or unwilling to complete questionnaires throughout the duration of the study.
研究组 & 干预措施
Veterans undergoing total knee replacement
Investigation of whether prehabilitation and a week long intense individualised rehabilitation period after TKR surgery has a positive impact on functional and mental outcomes, and whether these are sustained for up to 12 months post-surgery.
结局指标
主要结局
Clinical impact using the Oxford Knee Score
时间窗: From time of total knee replacement, up to 12 months following surgery
To evaluate the clinical impact, using the Oxford Knee Score, of the PREP Programme for Veterans up to 1 year following total knee replacement surgery. The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure (PROM) developed by the University of Oxford designed to assess knee pain and function, primarily in patients undergoing knee replacement surgery or managing knee osteoarthritis. Each question is scored 0-4, giving a total score from 0 (severe knee problems) to 48 (satisfactory joint function). Higher scores indicate better knee health.
次要结局
- Correlation of Baseline PANAS score and primary outcome - the Oxford Knee Score(From baseline, up to 12 months post-surgery)
- Correlation of Baseline PANAS score and the PROM - The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Index(From baseline to 12 months post surgery)
- Incidences of manipulations under anaesthetic(From surgery, up to and 12 months following TKR surgery.)
- Most responsive outcome measures(From baseline, up to 12 months post-surgery.)
- Practicality of delivering individualised prehabilitation and/or intensive post-operative rehabilitation(From baseline, up to 12 months post-surgery)