title: The long-term effect of minimalist shoes on running performance and injury: design of a randomised controlled trial.
abstract: BACKGROUND
  The outcome of the effects of transitioning to minimalist running shoes is a topic of interest for runners and scientists. However, few studies have investigated the longer term effects of running in minimalist shoes. The purpose of this randomised controlled trial (RCT) is to investigate the effects of a 26 week transition to minimalist shoes on running performance and injury risk in trained runners unaccustomed to minimalist footwear.
  
  
  METHODS
  A randomised parallel intervention design will be used. Seventy-six trained male runners will be recruited. To be eligible, runners must be aged 18-40 years, run with a habitual rearfoot footfall pattern, train with conventional shoes and have no prior experience with minimalist shoes. Runners will complete a standardised transition to either minimalist or control shoes and undergo assessments at baseline, 6 and 26 weeks. 5 km time-trial performance (5TT), running economy, running biomechanics, triceps surae muscle strength and lower limb bone mineral density will be assessed at each time point. Pain and injury will be recorded weekly. Training will be standardised during the first 6 weeks. Primary statistical analysis will compare 5TT between shoe groups at the 6-week time point and injury incidence across the entire 26-week study period.
  
  
  BACKGROUND
  This RCT has been approved by the Human Research Ethics Committee of the University of South Australia. Participants will be required to provide their written informed consent prior to participation in the study. Study findings will be disseminated in the form of journal publications and conference presentations after completion of planned data analysis.
  
  
  BACKGROUND
  This RCT has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000642785).
authors: Alliance for Research in Exercise, Nutrition and Activity (ARENA), Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
authors: Joel T
authors: http://orcid.org/0000-0002-0997-4878
authors: JT
authors: Fuller
authors: Alliance for Research in Exercise, Nutrition and Activity (ARENA), Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
authors: Dominic
authors: D
authors: Thewlis
authors: Alliance for Research in Exercise, Nutrition and Activity (ARENA), Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
authors: Margarita D
authors: MD
authors: Tsiros
authors: Australian Institute of Sport, Bruce, Australian Capital Territory, Australia.
authors: Nicholas A T
authors: NA
authors: Brown
authors: Alliance for Research in Exercise, Nutrition and Activity (ARENA), Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
authors: Jonathan D
authors: JD
authors: Buckley
mesh_terms: D000293:Adolescent; D000328:Adult; D001315:Australia; D015519:Bone Density; D006801:Humans; D008297:Male; D053580:Muscle Strength; D010146:Pain; D012107:Research Design; D012420:Running / Q000502:physiology*; D012775:Shoes / Q000145:classification*; D013178:Sports Medicine; D013995:Time; D055815:Young Adult
keywords: SPORTS MEDICINE; STATISTICS & RESEARCH METHODS