title: Early exercise after spinal cord injury ('Switch-On'): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Spinal cord injury (SCI) leads to a profound muscular atrophy, bone loss and bone fragility. While there is evidence that exercising paralysed muscles may lead to reversal of muscle atrophy in the chronic period after SCI, there is little evidence that exercise can prevent muscle changes early after injury. Moreover, whether exercise can prevent bone loss and microarchitectural decay is not clear.
  
  
  METHODS
  A multi-centre, parallel group, assessor-blinded randomised controlled trial will be conducted. Fifty participants with acute spinal cord injury will be recruited from four SCI units in Australia and New Zealand. Participants will be stratified by site and AIS status and randomised to an experimental or control group. Experimental participants will receive a 12-week programme of functional electrical stimulation (FES)-assisted cycling. Control participants will receive a 12-week programme of passive cycling. The primary outcome is muscle cross-sectional area of the thigh and calf measured using magnetic resonance images (MRI) of the leg. Secondary outcomes include serum biomarkers of SCI osteoporosis (sclerostin, P1NP and β-CTX), markers of immune function (IL-6, IL-10, FGF2, INF-γ, TNF-α), neurological function, body composition, depression and quality of life. Leg MRIs will be measured by a single blinded assessor based in Melbourne. Serum samples will be analysed in a central laboratory. All other characteristics will be measured at baseline and 12 weeks by blinded and trained assessors at each site. The first participant was randomised on 27 November 2012.
  
  
  CONCLUSIONS
  The results of this trial will determine the relative effectiveness of a 12-week programme of FES-assisted cycling versus passive cycling in preventing muscle atrophy and maintaining skeletal integrity after spinal cord injury.
  
  
  BACKGROUND
  ACTRN12611001079932 (18 October 2011).
authors.affiliation: Department of Medicine (Royal Melbourne Hospital), The University of Melbourne, Parkville, VIC 3010, Australia. m.galea@unimelb.edu.au.
authors.forename: Mary P
authors.initials: MP
authors.lastname: Galea
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Dunlop
authors.forename: Ruth
authors.initials: R
authors.lastname: Marshall
authors.forename: Jillian
authors.initials: J
authors.lastname: Clark
authors.forename: Leonid
authors.initials: L
authors.lastname: Churilov
mesh_terms: D001315:Australia; D001642:Bicycling; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D004599:Electric Stimulation Therapy; D005081:Exercise Therapy / Q000379:methods*; D006801:Humans; D035002:Lower Extremity; D008279:Magnetic Resonance Imaging; D018482:Muscle, Skeletal / Q000294:innervation* / Q000473:pathology; D009133:Muscular Atrophy / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D009520:New Zealand; D010024:Osteoporosis / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013116:Spinal Cord / Q000503:physiopathology*; D013119:Spinal Cord Injuries / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers