title: EXACT: exercise or advice after ankle fracture. Design of a randomised controlled trial.
abstract: BACKGROUND
  Ankle fractures are common. Management of ankle fractures generally involves a period of immobilisation followed by rehabilitation to reduce pain, stiffness, weakness and swelling. The effects of a rehabilitation program are still unclear. However, it has been shown that important components of rehabilitation programs may not confer additional benefits over exercise alone. The primary aim of this trial is to determine the effectiveness and cost-effectiveness of an exercise-based rehabilitation program after ankle fracture, compared to advice alone.
  
  
  METHODS
  A pragmatic randomised trial will be conducted. Participants will be 342 adults with stiff, painful ankles after ankle fracture treated with immobilisation. They will be randomly allocated using a concealed randomisation procedure to either an Advice or Rehabilitation group. Participants in the Advice group will receive verbal and written advice about exercise at the time of removal of immobilisation. Participants in the Rehabilitation group will be provided with a 4-week rehabilitation program that is designed, monitored and progressed by a physiotherapist, in addition to verbal and written advice. Outcomes will be measured by a blinded assessor at 1, 3 and 6 months. The primary outcomes will be activity limitation and quality-adjusted life years.
  
  
  CONCLUSIONS
  This pragmatic trial will determine if a rehabilitation program reduces activity limitation and improves quality of life, compared to advice alone, after immobilisation for ankle fracture.
authors: The George Institute for Global Health, Sydney Medical School, The University of Sydney, PO Box M201, Missenden Road Sydney, New South Wales 2000, Australia.
authors: Paula R
authors: PR
authors: Beckenkamp
authors: C Christine
authors: CC
authors: Lin
authors: Robert D
authors: RD
authors: Herbert
authors: Marion
authors: M
authors: Haas
authors: Kriti
authors: K
authors: Khera
authors: Anne M
authors: AM
authors: Moseley
mesh_terms: D000328:Adult; D016512:Ankle Injuries / Q000191:economics / Q000534:rehabilitation*; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005592:Fracture Fixation / Q000379:methods; D050723:Fractures, Bone / Q000191:economics / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D026741:Physical Therapy Modalities; D012107:Research Design / Q000592:standards; D016037:Single-Blind Method