title: Exercise and fall prevention self-management to reduce mobility-related disability and falls after fall-related lower limb fracture in older people: protocol for the RESTORE (Recovery Exercises and STepping On afteR fracturE) randomised controlled trial.
abstract: BACKGROUND
  Lasting disability and further falls are common and costly problems in older people following fall-related lower limb and pelvic fractures. Exercise interventions can improve mobility after fracture and reduce falls in older people, however the optimal approach to rehabilitation after fall-related lower limb and pelvic fracture is unclear. This randomised controlled trial aims to evaluate the effects of an exercise and fall prevention self-management intervention on mobility-related disability and falls in older people following fall-related lower limb or pelvic fracture. Cost-effectiveness of the intervention will also be investigated.
  
  
  METHODS
  A randomised controlled trial with concealed allocation, assessor blinding for physical performance tests and intention-to-treat analysis will be conducted. Three hundred and fifty people aged 60 years and over with a fall-related lower limb or pelvic fracture, who are living at home or in a low care residential aged care facility and have completed active rehabilitation, will be recruited. Participants will be randomised to receive a 12-month intervention or usual care. The intervention group will receive ten home visits from a physiotherapist to prescribe an individualised exercise program with motivational interviewing, plus fall prevention education through individualised advice from the physiotherapist or attendance at the group based "Stepping On" program (seven two-hour group sessions). Participants will be followed for a 12-month period. Primary outcome measures will be mobility-related disability and falls. Secondary outcomes will include measures of balance and mobility, falls risk, physical activity, walking aid use, frailty, pain, nutrition, falls efficacy, mood, positive and negative affect, quality of life, assistance required, hospital readmission, and health-system and community-service contact.
  
  
  CONCLUSIONS
  This study will determine the effect and cost-effectiveness of this exercise self management intervention on mobility-related disability and falls in older people who have recently sustained a fall-related lower limb or pelvic fracture. The results will have implications for the design and implementation of interventions for older people with fall related lower limb fractures. The findings of this study will be disseminated in peer-reviewed journals and through professional and scientific conferences.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12610000805077.
authors.affiliation: The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia. csherrington@georgeinstitute.org.au.
authors.forename: Catherine
authors.initials: C
authors.lastname: Sherrington
authors.affiliation: The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia. nfairhall@georgeinstitute.org.au.
authors.forename: Nicola
authors.initials: N
authors.lastname: Fairhall
authors.affiliation: The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia. ckirkham@georgeinstitute.org.au.
authors.forename: Catherine
authors.initials: C
authors.lastname: Kirkham
authors.affiliation: Discipline of Occupational Therapy, Faculty of Heath Sciences, The University of Sydney, Sydney, Australia. lindy.clemson@sydney.edu.au.
authors.forename: Lindy
authors.initials: L
authors.lastname: Clemson
authors.affiliation: Sydney School of Public Health, The University of Sydney, Sydney, Australia. Kirsten.Howard@unisa.edu.au.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Howard
authors.affiliation: Northern Clinical School, Sydney Medical School, The University of Sydney, Sydney, Australia. constance.vogler@sydney.edu.au.|Department of Aged Care, Royal North Shore Hospital, Sydney, Australia. constance.vogler@sydney.edu.au.
authors.forename: Constance
authors.initials: C
authors.lastname: Vogler
authors.affiliation: Prince of Wales Clinical School, University of New South Wales, Sydney, Australia. j.close@neura.edu.au.|Neuroscience Research Australia, University of New South Wales, Sydney, Australia. j.close@neura.edu.au.
authors.forename: Jacqueline C T
authors.initials: JC
authors.lastname: Close
authors.affiliation: The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia. amoseley@georgeinstitute.org.au.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Moseley
authors.affiliation: John Walsh Centre for Rehabilitation Research, Sydney Medical School Northern, The University of Sydney, St Leonards, Australia. ian.cameron@sydney.edu.au.
authors.forename: Ian D
authors.initials: ID
authors.lastname: Cameron
authors.affiliation: John Walsh Centre for Rehabilitation Research, Sydney Medical School Northern, The University of Sydney, St Leonards, Australia. jenson.mak@health.nsw.gov.au.|Department of Geriatric Medicine, Gosford Hospital, Gosford, Australia. jenson.mak@health.nsw.gov.au.
authors.forename: Jenson
authors.initials: J
authors.lastname: Mak
authors.affiliation: Northern Clinical School, Sydney Medical School, The University of Sydney, Sydney, Australia. David.Sonnabend@health.nsw.gov.au.
authors.forename: David
authors.initials: D
authors.lastname: Sonnabend
authors.affiliation: Neuroscience Research Australia, University of New South Wales, Sydney, Australia. s.lord@neura.edu.au.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Lord
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia / Q000453:epidemiology; D019468:Disease Management; D005081:Exercise Therapy / Q000379:methods; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology* / Q000628:therapy*; D006801:Humans; D035002:Lower Extremity / Q000293:injuries; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D009520:New Zealand / Q000453:epidemiology; D011788:Quality of Life; D012648:Self Care / Q000379:methods*; D016037:Single-Blind Method
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