Title: Effectiveness of progressive exercise versus best practice advice for people aged 50years and over with ankle fractures: the AFTER trial
Funder: Department of Health and Social Care

Abstract: Research question To determine the effectiveness of physiotherapist supervised progressive exercise compared to best practice advice in improving ankle function in people aged 50 years and over after ankle fracture. Background Ankle fractures are very common, accounting for 9% of all fractures managed in secondary care. In the UK, incidence is highest in people aged 50 years and over. Treatments for ankle fractures range from conservative plaster casts to surgical fixation. Weight bearing and ankle movement restrictions are usually lifted by the orthopaedic team 6 weeks after injury. Two thirds of patients are referred to see a physiotherapist for supervised rehabilitation. Referral patterns vary both within and between hospitals. The variation reflects that referrals are currently being made based on local practice or clinical opinion due to a lack of robust evidence to inform national guidance. The relevant James Lind Alliance Priority Setting Partnership ranked What is the best physiotherapy and/or occupational therapy regime for adults during out-of-hospital recovery from a fragility fracture of the lower limb? as the second highest research priority. Objectives The primary objective is to quantify and draw inferences on differences in ankle function between the trial intervention groups (progressive exercise vs best practice advice) at 6 months post-randomisation. Methods A feasibility RCT established clinical and patient equipoise and also showed that recruitment, intervention adherence and retention were feasible. Study design and the interventions were co-developed and optimised with patient and clinician stakeholders. This definitive RCT will be conducted in at least 20 UK hospitals and their related physiotherapy services. Participants will be people aged 50 years and over with an ankle fracture that have no medical reasons for not being able to participate in an exercise programme. Allocation will be 1:1 using a centralised computer randomisation service stratified by initial management (surgical vs non-surgical) and recruitment centre to either best practice advice or best practice advice followed by progressive exercise sessions. Progressive exercise is tailored to this patient group and involves 4 to 6 session with a physiotherapist. The primary outcome will be ankle function measured by the Olerud and Molander Ankle Score at 6 months. Secondary outcomes include ankle function at 4 months, and health-related quality of life, fear of falls, self-efficacy, physical activity, risk of related complications and resource use collected at 4 and 6 months. Assuming 5% significance, 90% power and 15% attrition we will need to recruit a sample of 344 participants. Timelines for delivery 0-5 months: regulatory approvals and site set up 6-21 months: recruitment 22-29 months: follow-up 30-34 months: analysis and reporting Anticipated Impact and Dissemination Findings will be published in peer-reviewed open access journals and shared at conferences. Our PPI co-applicant will support development of lay summaries and will be actively involved in reaching patient networks. The results will inform NICE guidelines on non-complex fractures.

Lay abstract: Around 1 in 10 of all people attending hospital with a broken bone have injured their ankle joint. Most of these injuries occur in people aged 50 years and over as a result of a fall from a standing height. After a broken ankle is treated with or without surgery, the ankle is kept still in a boot or cast for around six weeks. Keeping the ankle still protects it as it heals but causes stiffness and weakness. Putting weight through the ankle after the boot or cast is removed is difficult. People often feel unsteady and lack confidence. At this time, health care professionals are recommended to provide advice on early ankle exercises and on how to gradually return to daily life. After this initial advice, there is no national guidance on whether further rehabilitation under the supervision of a physiotherapist should be provided. Previous research in younger adults found additional physiotherapy did not improve recovery, but it is not clear whether older adults would benefit. As extra sessions of physiotherapy can be difficult for patients to attend and are costly to the health service it is important to find out if they really improve recovery. Our study will find out if referral for physiotherapy appointments after a person over 50 years has suffered a broken ankle improves recovery when compared to good quality advice on self-management. To compare the two treatments, 344 people will be recruited to take part. Participants will be placed by chance into one of two groups by a computer program, this will make sure that the groups are similar and the comparison is fair. Over a 6-month period participants will be asked about their health, walking ability and other daily activities, as well as any complications and specific costs. One limitation of the study is that people with cognitive impairment are currently not eligible for inclusion in the trial as it is likely they would not be able to engage fully with the self-management advice and independent home exercises. To allow for more inclusivity in future research involving self-management, we will conduct a work package alongside the AFTER trial to explore the experience and support needs of people with cognitive impairment experience and their carers. This project was developed and will be run by a team of patient representatives, clinical experts in trauma rehabilitation and orthopaedic surgery, study management specialists, and experienced statisticians. The Oxford Clinical Trials Research Unit, based within the University of Oxford, will support the study. Monitoring committees of patient representatives and independent experts will oversee the safety of participants and the progress and conduct of the study. Findings of the research will be published so that it is free to access in scientific journals and shared at conferences. Our PPI research team member will support development of lay summaries and will be actively involved in reaching patient networks.

Research activity codes: 6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS