Introduction Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.
The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.
Methods and analysis A multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.
Ethics and dissemination Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.
Trial registration number ISRCTN16612336
- ankle fractures
- clinical trial
- exercise therapy
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Contributors DJK is the chief investigator and conceived and designed the study, was awarded the funding and drafted the manuscript. MLC, ET, SH, VSB, SJD, ACR, KW and SEL contributed to study design and provided specific content and edited the manuscript. SJD oversees the statistical aspects of the study. ET oversees the qualitative substudy. VSB has provided trial management oversight. All authors have reviewed and approved the manuscript.
Funding This report is independent research supported by the National Institute for Health Research (NIHR Post-Doctoral Fellowship, Dr David Keene, PDF-2016-09-056). The report was supported by the NIHR Biomedical Research Centre, Oxford. Professor Lamb receives funding from the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust.
Disclaimer The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The study sponsor and funders had no role in study design, writing of the report, and the decision to submit the report for publication.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study has been approved by the South Central – Hampshire B Research Ethics Committee (Ref: 18/SC/0281) and the Health Research Authority.
Provenance and peer review Not commissioned; externally peer reviewed.
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