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|Rehabilitation after immobilization for ankle fracture: the EXACT randomized clinical trial|
|Moseley AM, Beckenkamp PB, Haas M, Herbert RD, Lin C-WC, for the EXACT Team|
|JAMA 2015 Oct 6;314(13):1376-1385|
|8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*|
IMPORTANCE: The benefits of rehabilitation after immobilization for ankle fracture are unclear. OBJECTIVES: To determine the effectiveness of a supervised exercise program and advice (rehabilitation) compared with advice alone and to determine if effects are moderated by fracture severity or age and sex. DESIGN, SETTING, AND PARTICIPANTS: The EXACT trial was a pragmatic, randomized clinical trial conducted from December 2010 to June 2014. Patients with isolated ankle fracture presenting to fracture clinics in 7 Australian hospitals were randomized on the day of removal of immobilization. Of 571 eligible patients, 357 chose not to participate and 214 were allocated to rehabilitation (n = 106) or advice alone (n = 108), with 194 (91%) followed up at 1 month, 173 (81%) at 3 months, and 170 (79%) at 6 months. There were no withdrawals attributed to adverse effects. Recruitment terminated early on December 31, 2013 (planned enrollment 342; actual 214), because funding was exhausted. INTERVENTIONS: Supervised exercise program and advice about self-management (rehabilitation) (individually tailored, prescribed, monitored, and progressed) or advice alone, both delivered by a physical therapist. MAIN OUTCOMES AND MEASURES: Primary outcomes were activity limitation assessed using the Lower Extremity Functional Scale (score range 0 to 80; higher scores indicate better activity), and quality of life assessed using the Assessment of Quality of Life (score range 0 to 1; higher scores indicate better quality of life), measured at baseline and at 1, 3 (primary time point), and 6 months. RESULTS: Mean activity limitation and quality of life at baseline were 30.1 (SD 12.5) and 0.51 (SD 0.24), respectively, for advice and 30.2 (SD 13.2) and 0.54 (SD 0.24) for rehabilitation, increasing to 64.3 (SD 13.5) and 0.85 (SD 0.17) for advice versus 64.3 (SD 15.1) and 0.85 (SD 0.20) for rehabilitation at 3 months. Rehabilitation was not more effective than advice for activity limitation (mean effect at 3 months 0.4 (95% CI -3.3 to 4.1)) or quality of life (-0.01 (95% CI -0.06 to 0.04)). Treatment effects were not moderated by fracture severity or age and sex. CONCLUSIONS AND RELEVANCE: A supervised exercise program and advice did not confer additional benefits in activity limitation or quality of life compared with advice alone for patients with isolated and uncomplicated ankle fracture. These findings do not support the routine use of supervised exercise programs after removal of immobilization for patients with isolated and uncomplicated ankle fracture. TRIAL REGISTRATION: anzctr.org.au identifier ACTRN12610000979055.