PREPARE KIDS

Research Question

To assess clinical and cost-effectiveness of prehabilitation combined with usual NHS care compared to usual NHS care alone in children undergoing elective lower limb orthopaedic surgery.

Background

Preparing adults for surgery helps them recover faster and spend less time in hospital. We want to see if the same is true for children undergoing elective lower limb orthopaedic surgery. This was identified as one of the top 10 research priorities by the James Lind Alliance for paediatric orthopaedics.

Specifically, we want to find out whether a preparation programme (prehabilitation) improves recovery, reduces hospital stays, and saves the NHS money.

A pilot study showed that a prehabilitation programme - covering mobility aid training, personalised exercises, and guidance on postoperative expectations - shortened hospital stays and improved the overall patient experience.

We are now conducting a larger study called PREPARE KIDS.

Aims and Objectives

Primary Objective

• To assess whether a 45-minute prehabilitation session, delivered in clinic approximately six weeks before surgery (aligned with the POAC where possible), in addition to usual NHS care, improves functional mobility compared to usual care alone.  Our primary outcome is functional mobility, assessed using the PROMIS-Computer Adaptive Test (CAT) Mobility Score for Children (MSC), measured two weeks post-operatively.

Secondary Objectives

• Functional mobility (PROMIS-CAT MSC): Baseline; 2, 6, and 12 weeks post-op
• Pain (Wong-Baker FACES Scale): Baseline; 2, 6, and 12 weeks post-op
• Health-related quality of life (EQ-5D-Y-3L): Baseline and 12 weeks post-op
• Carer health and wellbeing (EQ-HWB): 12 weeks post-op
• Parental satisfaction and school absenteeism: 12 weeks post-op
• Length of hospital stay: 12 weeks post-op
• Complications: 12 weeks post-op
• Resource use: Healthcare services, additional childcare services, and carer time off work (12 weeks post-op)

Oxford Study Team

• Chief Investigator: Mrs Marie-Caroline Nogaro
• Chief Investigator: Professor Tim Theologis 
• Chief Investigator: Mrs Catherine Barry
• SITU Trials Portfolio Manager (Operational Lead): Loretta Davies
• Clinical Trial Manager: Megan Stone
• Senior Data Manager: Heidi Fletcher

• Trial Assistant: Davy Byrne
• PA to Professor Tim Theologis: Julie Damnjanovic

• Senior Statistician: Victoria Harris
• Statistician: Lewis Kinuthia

Method

National study recruiting 524 children aged 5-14 years (up to their 15^th birthday) from at least 20 NHS hospitals across the UK. Participants will be randomised via the Oxford Clinical Trials Research Unit to one of two groups:

1. PREPARE KIDS programme + usual care:

A single 45-minute prehabilitation session in clinic about 6 weeks before surgery (aligned with the preoperative assessment clinic (POAC) where possible). The session includes:

• A personalised exercise programme
• Training in using mobility aids
• Discussion of a pre-agreed discharge plan, including expected length of stay and pain/functional management

This is provided in addition to usual NHS care.

1. Usual care alone:
   Participants will attend a POAC visit (or any other clinic in the preoperative period that forms part of usual NHS care). Usual care typically includes:

• Surgical consent
• Clinical examination and documentation
• Any required preoperative tests (blood tests, imaging)

The exact details may vary depending on the site’s usual practice.