Progressive exercise versus best practice advice for adults aged 50 years or over after ankle fracture: the AFTER pilot randomised controlled trial

Abstract

OBJECTIVE: The aim of the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study, a multicentre external pilot parallel-group randomised controlled trial (RCT), was to assess feasibility of a definitive trial comparing rehabilitation approaches after ankle fracture. SETTING: Five UK National Health Service hospitals. PARTICIPANTS: Participants were aged 50 years and over with an ankle fracture requiring immobilisation for at least 4 weeks. INTERVENTIONS: Participants were allocated 1:1 via a central web-based randomisation system to: (1) best practice advice (one session of physiotherapy, up to two optional additional advice sessions) or (2) progressive exercise (up to six sessions of physiotherapy). PRIMARY OUTCOME MEASURES: Feasibility: (1) participation rate, (2) intervention adherence and (3) retention. RESULTS: Sixty-one of 112 (54%) eligible participants participated, exceeding progression criteria for participation of 25%. Recruitment progression criteria was 1.5 participants per site per month and 1.4 was observed. At least one intervention session was delivered for 28/30 (93%) of best practice advice and 28/31 (90%) of progressive exercise participants, exceeding the 85% progression criteria. For those providing follow-up data, the proportion of participants reporting performance of home exercises in the best practice advice and the progressive exercise groups at 3 months was 20/23 (87%) and 21/25 (84%), respectively. Mean time from injury to starting physiotherapy was 74.1 days (95% CI 53.9 to 94.1 days) for the best practice advice and 72.7 days (95% CI 54.7 to 88.9) for the progressive exercise group. Follow-up rate (6-month Olerud and Molander Ankle Score) was 28/30 (93%) for the best practice advice group and 26/31 (84%) in the progressive exercise group with an overall follow-up rate of 89%. CONCLUSIONS: This pilot RCT demonstrated that a definitive trial would be feasible. The main issues to address for a definitive trial are intervention modifications to enable earlier provision of rehabilitation and ensuring similar rates of follow-up in each group. TRIAL REGISTRATION NUMBER: ISRCTN16612336.