Title: Optimising rehabilitation after ankle fracture in older adults: physiotherapy intervention refinement and a randomised, multicentre, feasibility study
Funder: Department of Health and Social Care

Abstract: Background The number of older adults with ankle fractures undergoing surgery in the NHS is increasing. Six months after surgery 2 in 5 patients over 60 years do not achieve a good recovery of ankle function. On average these patients lose 30% of pre-injury function, having implications for the patient, their families, health and social care, and the wider economy. For 6 weeks after surgery the ankle is immobilised in a cast or boot and weight-bearing is limited. Provision of physiotherapy after immobilisation varies but usual care for older adults in the NHS is an advice session with one or two follow-up visits. Studies to date have not demonstrated benefits for 4-12 weeks of physiotherapy sessions over an advice session. Older adults have not been adequately represented in studies, nor have physiotherapy interventions been designed to address their complex needs. Aims For older adults after ankle fracture surgery: To refine best-practice usual care and supervised progressive functional exercise interventions To assess feasibility of a definitive clinical and cost-effectiveness RCT Plan of investigation A programme of 4 related work packages over 4 years supported by the Centre for Rehabilitation Research and Oxford Clinical Trials Research Unit: 1. Systematic review: candidate exercises will be identified from the last 10 years of research into rehabilitation of lower limb injuries in older adults.2. A prognostic factors analysis using the Ankle Injury Management Trial cohort (n=620) will identify modifiable targets for physiotherapy intervention. 3. The first 2 work packages will result in more exercise and advice options than practical, so an expert consensus process using modified nominal group technique will be used to determine a balance between preferences and sufficient doses of exercise to achieve a physiological response. Participants will be 12 clinicians and 12 patient representatives. Intervention manuals and supporting materials will be developed after this phase. 4. Randomised, multicentre, feasibility study with an embedded qualitative study. Forty-eight participants aged over 60 years at 6 weeks after ankle fracture surgery from 3 secondary care hospitals will be randomly allocated 1:1 to best-practice usual care or best-practice usual care plus supervised progressive functional exercises via a web-based randomisation service. Participants with substantial cognitive impairment or other major lower limb pathology will be excluded. Best-practice usual care will be an advice session on self-management and exercise, supported by patient support materials (booklet and videos) and the option of an additional one or two sessions to reinforce. Progressive functional exercises will involve the same advice session plus up to 5 additional outpatient physiotherapy sessions, enabling exercises to be practiced and progressed under supervision. Supervised exercise prescription aims to ensure a sufficient training stimulus to achieve the physiological response required to improve movement quality and muscle strength. Interventions will be implemented via manuals, training and monitoring. Outcome measures at 2 and 4 months by blinded assessors: Olerud-Molander Ankle Score, pain, joint range, muscle strength, Short Physical Performance Battery, quality of life, functional impairment, sleep disturbance, fear of falls, self-efficacy and resource use. Fifteen participants will be interviewed to understand the experience of study participation and the interventions; a thematic analysis approach will be employed. Feasibility success criteria: 1) study participation rate of at least 25% 2) 48 participants over 3 sites in 2.5 years (1 participant/month/site) 3) 85% participants complete interventions per protocol and attend 4 month study follow-up. Benefits to patients and the NHS The feasibility study will inform decision-making about proceeding to full-scale evaluation in a definitive RCT to determine which intervention offers the most clinically and cost-effective approach for rehabilitating older adults after ankle fracture in the NHS.

Lay abstract: Background to the research Broken ankles represent a high proportion of injuries treated in the National Health Service (NHS). The most severe injuries require surgery to align the bones until healing has occurred. Broken ankles are the second most common injury undergoing surgical repair in the NHS. An increasing number of these injuries are in adults over 60 years old as the age of the population is rising. For older adults, an ankle injury can be the start of a decline in their ability to move around confidently as the limb can feel weak, walking is difficult, balance worsens and a fear of further falls is common. Our recent study found that, on average, older adults had lost 30% of their ankle function at 6 months after breaking their ankle. About 2 in every 5 patients did not experience a good recovery of ankle function. After surgery there is a 6 week period of splinting to protect the injured ankle and then patients start the active recovery process, which usually takes at least 6 months. Physiotherapy provision in the NHS for older adults after surgery varies from hospital to hospital. Patients may not get any physiotherapy, but usual care is a session of advice with the option of a further one or two sessions follow-up. In clinical trials to date longer courses of supervised physiotherapy over 4 to 12 weeks have not demonstrated advantages for patients, compared with a single session of advice. A major criticism is that these studies have not focussed on older adults, who have the greatest and most complex needs. Aim of the research A programme of research will refine two different approaches to delivering physiotherapy for older adults after surgery for a broken ankle. This will be followed by a study in 3 hospitals to assess the feasibility of conducting a large randomised controlled trial to test which of the approaches offers the best and most affordable approach to rehabilitation in the NHS. Research plan The programme is formed of 4 complimentary pieces of research: Study 1: A systematic review of previous research will identify candidate exercises to aid recovery after lower limb injury in older adults. Study 2: A large set of data from 620 patients with a broken ankle who were aged over 60 years will be analysed to identify physiotherapy treatment targets. Study 3: Using information from the first two steps of research, this study will prioritise advice and exercise for inclusion in the physiotherapy interventions. A consensus group meeting will involve 12 clinicians and 12 patient representatives. The outcome will finalise refinement of interventions, aiming to balance the need to have a sufficient dose of exercise but also be acceptable to clinicians, carers and patients. Study 4: A feasibility study will be conducted at 3 hospitals. Forty-eight patients aged over 60 years will be randomly allocated to one of two different types of physiotherapy. One type of physiotherapy will be best-practice usual care, which will include advice on self-management and exercise, and access to an information booklet and video. There will be one or two optional extra contacts with the physiotherapist to reinforce advice. The second type of physiotherapy will involve the same usual care advice plus up to 5 additional outpatient physiotherapy sessions. The extra sessions enable functional progressive exercises to be practised and progressed under supervision. The research aims to estimate rates of recruitment and the safety, acceptability and adherence to the physiotherapy interventions. Fifteen participants will be interviewed to better understand their experience of taking part in the study and of the interventions. Patient and public involvement The research planning involved patient representatives, who reviewed this summary and influenced the research focus on older adults. Volunteers have agreed to be patient representatives on the fellowship steering committee and to form an advisory group. Dissemination I will involve patient representatives in dissemination of the research findings. In addition to publications in medical journals, a results summary will be offered to study participants, patient groups and charities. To ensure the findings influence practice I will engage with key professional specialist societies by presenting at conferences. The major anticipated output from the research will be an application to secure funding to conduct a large definitive randomised controlled trial to determine which approach to physiotherapy improves patient recovery, confidence and independence for older people and offers the best targeted use of NHS resources. CHAR(13) + CHAR(10)

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