title: What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Physical inactivity and falls in older people are important public health problems. Health conditions that could be ameliorated with physical activity are particularly common in older people. One in three people aged 65 years and over fall at least once annually, often resulting in significant injuries and ongoing disability. These problems need to be urgently addressed as the population proportion of older people is rapidly rising. This trial aims to establish the impact of a combined physical activity and fall prevention intervention compared to an advice brochure on objectively measured physical activity participation and mobility-related goal attainment among people aged 60+.
  
  
  METHODS
  A randomised controlled trial involving 130 consenting community-dwelling older people will be conducted. Participants will be individually randomised to a control group (n = 65) and receive a fall prevention brochure, or to an intervention group (n = 65) and receive the brochure plus physical activity promotion and fall prevention intervention enhanced with health coaching and a pedometer. Primary outcomes will be objectively measured physical activity and mobility-related goal attainment, measured at both six and 12 months post randomisation. Secondary outcomes will include: falls, the proportion of people meeting the physical activity guidelines, quality of life, fear of falling, mood, and mobility limitation. Barriers and enablers to physical activity participation will be measured 6 months after randomisation. General linear models will be used to assess the effect of group allocation on the continuously-scored primary and secondary outcome measures, after adjusting for baseline scores. Between-group differences in goal attainment (primary outcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome). Modified Poisson regression models will compare groups on dichotomous outcome measures. Analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach.
  
  
  CONCLUSIONS
  This trial will address a key gap in evidence regarding physical activity and fall prevention for older people and will evaluate a program that could be directly implemented within Australian health services.
  
  
  BACKGROUND
  ACTRN12614000016639, 7/01/2014.
authors.affiliation: The George Institute for Global Health, Sydney, Australia. atiedemann@georgeinstitute.org.au.|The University of Sydney, Camperdown, Australia. atiedemann@georgeinstitute.org.au.
authors.forename: Anne
authors.initials: A
authors.lastname: Tiedemann
authors.affiliation: The George Institute for Global Health, Sydney, Australia. SPaul@georgeinstitute.org.au.|The University of Sydney, Camperdown, Australia. SPaul@georgeinstitute.org.au.
authors.forename: Serene
authors.initials: S
authors.lastname: Paul
authors.affiliation: The George Institute for Global Health, Sydney, Australia. bramsay@georgeinstitute.org.au.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Ramsay
authors.affiliation: The George Institute for Global Health, Sydney, Australia. sandra.orourke@sydney.edu.au.|Neuroscience Research Australia, Randwick, Australia. sandra.orourke@sydney.edu.au.
authors.forename: Sandra D
authors.initials: SD
authors.lastname: O'Rourke
authors.affiliation: The George Institute for Global Health, Sydney, Australia. kchamberlain@georgeinstitute.org.au.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Chamberlain
authors.affiliation: The George Institute for Global Health, Sydney, Australia. ckirkham@georgeinstitute.org.au.
authors.forename: Catherine
authors.initials: C
authors.lastname: Kirkham
authors.affiliation: University of Western Sydney, Penrith, Australia. d.merom@uws.edu.au.
authors.forename: Dafna
authors.initials: D
authors.lastname: Merom
authors.affiliation: The George Institute for Global Health, Sydney, Australia. nikifairhall@gmail.com.
authors.forename: Nicola
authors.initials: N
authors.lastname: Fairhall
authors.affiliation: The George Institute for Global Health, Sydney, Australia. jsouza@georgeinstitute.org.au.
authors.forename: Juliana S
authors.initials: JS
authors.lastname: Oliveira
authors.affiliation: The George Institute for Global Health, Sydney, Australia. leanne.hassett@sydney.edu.au.|The University of Sydney, Camperdown, Australia. leanne.hassett@sydney.edu.au.
authors.forename: Leanne
authors.initials: L
authors.lastname: Hassett
authors.affiliation: The George Institute for Global Health, Sydney, Australia. csherrington@georgeinstitute.org.au.|The University of Sydney, Camperdown, Australia. csherrington@georgeinstitute.org.au.
authors.forename: Catherine
authors.initials: C
authors.lastname: Sherrington
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D056044:Actigraphy / Q000379:methods; D000328:Adult; D000368:Aged; D001315:Australia; D005081:Exercise Therapy / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D009043:Motor Activity / Q000502:physiology; D017063:Outcome Assessment, Health Care; D011322:Primary Prevention / Q000458:organization & administration*; D011788:Quality of Life; D012107:Research Design; D012111:Residence Characteristics; D016896:Treatment Outcome