Prehabilitation for children having planned lower limb surgery: can preparation before surgery improve recovery?
| ISRCTN | ISRCTN76102667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76102667 |
| Integrated Research Application System (IRAS) | 366508 |
| Central Portfolio Management System (CPMS) | 74449 |
| National Institute for Health and Care Research (NIHR) | 167724 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health and Care Research |
- Submission date
- 11/06/2026
- Registration date
- 22/06/2026
- Last edited
- 30/10/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Waiting times for children needing bone and joint surgery are increasing, which can be difficult for children and their families. In adults, rehabilitation programmes before surgery (known as prehabilitation) can help improve recovery and reduce length of hospital stay, and there is some evidence to suggest it’s more cost-effective for the NHS. However, we don’t know if this works the same way for children. Before starting PREPARE KIDS, we carried out a smaller study. The results suggested that prehabilitation could reduce the time children spend in hospital after surgery. The programme involved children learning how to use walking aids, practising exercises similar to those they may do after surgery, and understanding what to expect during recovery. We are now carrying out a larger study. The aim of the PREPARE KIDS study is to find out whether this prehabilitation programme can improve recovery in children undergoing planned lower limb surgery. The main measure of recovery will be children's functional mobility at two weeks after surgery, assessed using the PROMIS questionnaire.
Who can participate?
Children aged 5 to 14 years old (i.e., from their 5th birthday up to, but not including, their 15th birthday) who are awaiting planned (non-emergency) hip, leg or foot surgery.
What does the study involve?
Once participants agree to take part, they will complete questionnaires before surgery. Children will then be randomly assigned to one of two groups. One group will receive a prehabilitation ('Get-Ready') session alongside usual care before surgery. This session includes learning how to use mobility aids if needed, practising exercises similar to those used after surgery, and discussing what to expect during recovery. The other group will receive usual NHS care alone. Usual care refers to the standard care children normally receive before surgery. This may vary slightly between hospitals but can include discussing the procedure with doctors, a clinical examination, and any necessary tests before surgery.
The child's surgery and postoperative care will take place as planned, regardless of which group they are assigned to.
Participants will be asked to complete follow-up questionnaires 2, 6, and 12 weeks after surgery.
What are the possible benefits and risks of participating?
Participation will help researchers understand whether preparing children for surgery can improve recovery. The findings may help improve care for children undergoing planned lower limb surgery in the future. The study team will also aim to make participation a positive experience and provide support and reassurance for children and their families throughout surgery and recovery.
Taking part in this study is considered safe; however, the following should be noted:
Exercises: Children allocated to the prehabilitation group will be asked to complete exercises before surgery. These exercises require additional time and may cause temporary muscle tiredness or mild discomfort.
Mobility aid training: Some children may receive training in the use of mobility aids, such as crutches or walking frames. As with normal use of these aids, there is a small risk of slipping or minor injury. Training will be provided by a qualified clinician to ensure safe use.
Where is the study run from?
The study is sponsored by the University of Oxford. It is coordinated and managed by the Surgical Intervention Trials Unit (SITU), part of the Oxford Clinical Trials Research Unit (OCTRU) at the University of Oxford. The study will take place at participating NHS hospitals across the United Kingdom.
When is the study starting and how long is it expected to run for?
August 2026 to October 2028
Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
1. Marie-Caroline Nogaro, marie-caroline.nogaro@ndorms.ox.ac.uk
2. PREPARE KIDS team, preparekids@ndorms.ox.ac.uk
Contact information
Public, Scientific
Surgical Intervention Trials Unit (SITU)
Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS)
University of Oxford
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
| megan.stone@ndorms.ox.ac.uk |
Principal investigator
University of Oxford, Botnar Institute for Musculoskeletal Sciences, Windmill Road
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0000-0001-8022-2823 |
|---|---|
| Marie-Caroline.Nogaro@ndorms.ox.ac.uk |
Scientific, Public
University of Oxford, Botnar Institute for Musculoskeletal Sciences, Windmill Road
Oxford
OX3 7LD
United Kingdom
| preparekids@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Pre-operative rehabilitation (prehabilitation) in elective lower limb paediatric orthopaedic surgery |
| Study acronym | PREPARE KIDS |
| Study objectives | To assess clinical and cost-effectiveness of prehabilitation compared to usual care for children undergoing elective lower limb orthopaedic surgery. |
| Ethics approval(s) |
Approved 06/07/2026, London - Fulham Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8021; fulham.rec@hra.nhs.uk), ref: 26/LO/0452 |
| Health condition(s) or problem(s) studied | Elective lower limb paediatric orthopaedic surgery |
| Intervention | The PREPARE KIDS study is a research study to find out whether giving children a prehabilitation session before planned lower limb surgery, alongside their usual NHS care (Group 1), helps them recover and move better after their operation compared with children who receive usual NHS care alone (Group 2). Children may be identified at participating hospitals using different methods, depending on local practice. These may include: 1. Waiting lists 2. Routine clinic appointments 3. Study advertising materials In all cases, the child’s direct clinical team will make the first contact and introduce the study using age-appropriate information, such as a study explainer animation/Participant Information Sheet (PIS). As part of the initial discussion between families and the direct clinical team, and if agreement is given to share details, the site research team may follow up with families as appropriate. Each site will complete screening forms to record basic information and any reasons why a child does not take part. Consent, assent and baseline information: If a family is interested, the site team will check whether the child is eligible to take part. If eligible: 1. Parents/guardians will be asked to give consent. 2. Children will be invited to give assent. Electronic consent and assent may take place either remotely or during a clinic visit. Families will have time to read the study information and ask questions before deciding whether to take part. Where electronic consent is not possible, written consent/assent may be obtained by post or in clinic. After consent/assent has been obtained, participants and families will complete a baseline questionnaire about the child’s health, pain and mobility. This must be completed before the child is randomised. Parent(s)/guardian(s), together with their child, will complete the questionnaires. Children aged 8 years and over will be invited to complete some questions about their own health and wellbeing (EQ-5D-Y-3L) and mobility (PROMIS Mobility Score for Children) if they are willing and able. If they choose not to, or if the child is under 8 years of age, this questionnaire will be completed by the parent/guardian with input from the child. This will be agreed at the start of the study (before group allocation). Some questions will be for parents/guardians only, such as those about their own health and wellbeing (EQ-HWB-9). After consent has been obtained and the baseline questionnaire completed, children will be randomly assigned to one of two groups. Each child has an equal chance of being in either group: Group 1: Prehabilitation programme plus usual NHS care Group 2: Usual NHS care only Group 1: Prehabilitation programme plus usual care: Children in this group will attend a prehabilitation session, lasting about 45 minutes, usually around 6 weeks before surgery. Where possible, this will take place on the same day as the child’s preoperative clinic. The prehabilitation session includes three key components: 1. An individually tailored exercise programme (the treating clinician will give the child exercises to practise before the surgery). 2. Training on how to use mobility aids (focused on practising how to move around safely using mobility aids like crutches or a frame). 3. A pre-agreed discharge plan (this includes how long they are expected to stay and how their pain and movement will be managed). The ‘Get-Ready’ session aims to help children prepare for recovery after surgery by practising exercises and, if needed, using mobility aids so they know what to expect. Children in this group will also receive all of their usual NHS care. Group 2: Usual NHS care only: The exact details may vary depending on each hospital’s usual practice. This may include consent for surgery, physical examinations, any required tests and other routine discussions such as checks to ensure a safe journey home, hospital contact details, wound care and guidance on anticipated time off school. Surgery and follow-up: All children will have their surgery as planned. After surgery, children and their parents/guardians will be asked to complete follow-up questionnaires at 2 weeks, 6 weeks and 12 weeks after surgery. Questionnaires are completed remotely electronically, with postal completion available if electronic completion is not feasible as back-up only. The questionnaires used in this study are widely used and quick to complete. Hospital records will also be reviewed to collect information such as length of hospital stay, use of healthcare services, and any complications related to surgery, from the time of surgery up to 12 weeks afterwards. Pilot phase and additional study components: The study includes an internal pilot phase (10 months) to make sure recruitment, study procedures, and data collection work as planned. This helps identify and fix any problems early, before the main study continues. Process evaluation: Led by the University of Warwick, this will involve remote (online or telephone) interviews with children, parents, clinicians, and researchers during both the internal pilot and main stages of the trial. The purpose is to maximise recruitment, reduce variation in how the intervention is delivered, and gain a better understanding of participants' experiences, trial processes, and how closely the intervention is delivered as intended during the main trial. Participants who are interested will be provided with information leaflets and will give their consent to take part. Health economics: This part of the study will help us understand whether the prehabilitation approach is cost-effective and what impact it could have on NHS resources. Justification for principal research question: The main outcome looks at how well children can move two weeks after surgery, as discussions with clinicians and patients/families have told us that early recovery of movement and strength are important for overall recovery. The timing for this (2 weeks postoperatively) allows the study to capture early benefits that might be missed if recovery was only measured later. The main outcome (PROMIS questionnaire) will be completed by parents/carers, with input from the child where appropriate. This approach is used because younger children are not recommended to complete it on their own, and the child and parent versions are not directly comparable. Young people, parents, and clinicians have helped shape this study. Their feedback has directly influenced the study design and the patient-facing materials used in the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
Functional mobility is measured using the PROMIS Mobility Score for Children (MSC), Parent Proxy Version, at 2 weeks postoperatively |
| Key secondary outcome measure(s) |
1. Functional mobility is measured using the PROMIS Mobility Score for Children (MSC), Parent Proxy Version, at baseline, 6 weeks, and 12 weeks postoperatively |
| Completion date | 31/10/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 524 |
| Key inclusion criteria | Main Study: 1. Aged 5-14 years (i.e., from their 5th birthday up to, but not including, their 15th birthday at the time of consent) 2. Scheduled for elective lower-limb surgery (hips to toes, excluding toenail surgery) Process Evaluation: Children: 1. Currently enrolled in the main study 2. Parent/guardian has provided informed consent for the child’s participation in the interview study 3. Child is willing and able to participate in the interview Parent/Guardian: 1. Parent/Guardian of a participant enrolled in the main study 2. Has provided consent to be contacted regarding interview study 3. Willing and able to give informed consent for participation in the interview study Site Clinical/Research Staff: 1. Clinical and research staff participating in the PREPARE KIDS study 2. Willing and able to give informed consent for participation in the interview study |
| Key exclusion criteria | Main Study: 1. The child is currently receiving a physiotherapy programme which replicates the content of PREPARE KIDS 2. The child and/or their parent(s)/guardian(s) are unable to comply with assessment procedures 3. Previous participation in PREPARE KIDS study Process Evaluation: Children: 1. Withdrawn from the main study Parent/Guardian: 1. No longer acting as parent/guardian of a participant enrolled in the main study 2. Child withdrawn from the main study Site Clinical/Research Staff: 1. No longer involved in the conduct of the main study |
| Date of first enrolment | 10/09/2026 |
| Date of final enrolment | 31/05/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
Study participating centres
Headley Way
Headington
Oxford
OX3 9DU
England
Stanmore
HA7 4LP
England
Tremona Road
Southampton
SO16 6YD
England
Bretton Gate
Bretton
Peterborough
PE3 9GZ
England
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
Beckett Street
Leeds
LS9 7TF
England
Marton Road
Middlesbrough
TS4 3BW
England
London
SW17 0QT
England
Eaton Road
West Derby
Liverpool
L12 2AP
England
Birmingham
B4 6NH
England
London
WC1N 3JH
England
Maes-y-coed Road
Cardiff
CF14 4HH
Wales
Oswestry
SY10 7AG
England
Stoke-on-trent
ST4 6QG
England
Clifford Bridge Road
Coventry
CV2 2DX
England
Uxbridge
UB8 3NN
England
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
England
Anlaby Road
Hull
HU3 2JZ
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request. At the end of the trial, the trial statistician will prepare a data-sharing package (including a dataset along with the corresponding metadata description) of de-identified participant data, provided sufficient anonymity of participants can be achieved. This data sharing package will cover the main results of the planned statistical analyses. Other trial data may be available upon reasonable request, provided sufficient safeguards to participant identification can be ensured and subject to agreement of relevant parties. De-identified research data may be shared with other organisations upon request. All requests for data sharing will be handled in accordance with the OCTRU Standard Operating Procedure on Data Sharing and will be considered in accordance with the data sharing policies of OCTRU, the Sponsor and funder(s). De-identified data may also be used for teaching and learning purposes. |
Editorial Notes
30/10/2026: Study participating centres updated.
11/09/2026: The date of first enrolment was changed from 28/08/2026 to 10/09/2026.
25/08/2026: The date of first enrolment was changed from 24/08/2026 to 28/08/2026.
13/08/2026: The following changes were made to the study record:
1. The date of first enrolment was changed from 03/08/2026 to 24/08/2026.
2. The ethics approval was added.
3. The target sample size at registration was changed from 20 to 524 (from approx. 20 hospitals).
11/06/2026: Study's existence confirmed by the NIHR.
