Evaluating the Clinical Impact of the Prehabilitation and Recovery for Enabling Potential (PREP) Clinical Care Pathway

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteo Arthritis of the Knee

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Marit N Dugard, PhD; Phone Number: +44 1691 404139; Email: naomi.dugard@nhs.net

Study Locations

• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • The Robert Jones and Agnes Hunt Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified from clinic lists at the Veterans Orthopaedic Service, Robert Jones and Agnes Hunt Orthopaedic Hospital. Patients that are Veterans, that have been listed for a total knee replacement surgery at the hospital and also agreed to enter into the PREP clinical pathway programme will be eligible to take part in this research study.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical impact using the Oxford Knee Score	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.	From time of total knee replacement, up to 12 months following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Baseline PANAS score and primary outcome - the Oxford Knee Score	To evaluate the association between baseline Positive and Negative Affect Schedule (PANAS) score and the Oxford Knee Score (OKS), and determine whether observed effects are sustained up to 12 months post-surgery The PANAS is a 20-item self-report measure to assess positive affect (PA) and negative affect (NA). PA is associated with pleasurable engagement with the environment, whereas NA reflects a dimension of a variety of negative states such as anger, guilt, or anxiety. 10 questions relate to PA and 10 to NA, each question is scored from 1 (Very slightly or not at all) to 5 (Extremely). PA scores are combined and range from 10-50, higher scores representing higher levels of positive affect. NA scores are combined and range from 10-50, lower scores representing lower levels of negative affect. The study will assess: Whether better outcome at 12 month (using the OKS; higher scores indicate better knee health) is observed in patients with higher PA and lower NA baseline scores.	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	To evaluate the association between baseline PANAS score and the WOMAC Osteoarthritis Index. The PANAS is described in 3. above. The WOMAC is widely used in the evaluation of Knee Osteoarthritis. The self-administered questionnaire consists of 24 items divided into 3 subscales: pain (5 items), Stiffness (2 items) and Physical Function (17 items). Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score; higher scores indicating worse pain, stiffness, and functional limitations. The study will assess: Whether better clinical outcome at 12 months post surgery (using the WOMAC Index; lower scores indicate better knee health) is observed in patients with higher PA scores and lower NA scores at baseline.	From baseline to 12 months post surgery
Incidences of manipulations under anaesthetic	To determine whether an individualised prehabilitation and/or post-operative rehabilitation reduces the incidences of manipulations under anaesthetic (MUAs) in Veterans undergoing a TKR	From surgery, up to and 12 months following TKR surgery.
Practicality of delivering individualised prehabilitation and/or intensive post-operative rehabilitation	To determine the practicality of delivering an individualised prehabilitation and/or intensive post-operative rehabilitation in Veterans who have undergone a total knee replacement (TKR).	From baseline, up to 12 months post-surgery

Collaborators and Investigators

• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Physiotherapy; Outcome; Prehabilitation
• Other Study ID Numbers: RL1 934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No