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.

Keywords: Clinical trials; Foot & ankle; Rehabilitation medicine.

Figure 1

Flow of participants through the Ankle Fracture Treatment: Enhancing Rehabilitation pilot trial. ¹One site has missing screening data for some of the randomised participants, so those who were randomised were added to the totals screened. ²Major ankle trauma defined as: open fracture wounds, external fixation or substantial skin loss or grafts, that would limit ankle or lower leg exercise. ³Compliance is defined as attending at least one session. ⁴Loss to follow-up is defined as no response at the 6-month follow-up. ⁵Olerud and Molander Ankle Score scores at 6 months.