title: The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease.
abstract: BACKGROUND
  Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer's disease. The Fitness for the Ageing Brain II (FABS II) study is a multicentre randomized controlled clinical trial (RCT) aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer's disease. This paper describes the background, objectives of the study, and an overview of the protocol including design, organization and data collection methods.
  
  
  METHODS
  The study will recruit 230 community-dwelling participants diagnosed with Alzheimer's disease. Participants will be randomly allocated to two treatment groups: usual care group or 24-week home-based program consisting of 150 minutes per week of tailored moderate physical activity. The primary outcome measure of the study is cognitive decline as measured by the change from baseline in the total score on the Alzheimer's disease Assessment Scale-Cognitive section. Secondary outcomes of interest include behavioral and psychological symptoms, quality of life, functional level, carer burden and physical function (strength, balance, endurance, physical activity). Primary endpoints will be measured at six and twelve months following the baseline assessment.
  
  
  CONCLUSIONS
  This RCT will contribute evidence regarding the potential benefits of a systematic program of physical activity as an affordable and safe intervention for people with Alzheimer's disease. Further, if successful, physical activity in combination with usual care has the potential to alleviate the symptoms of Alzheimer's disease and improve its management and the quality of life of patients and their carers.
  
  
  BACKGROUND
  Australia New Zealand Clinical Trials Registry ACTRN12609000755235.
authors.affiliation: National Ageing Research Institute, Melbourne, Australia. e.cyarto@nari.unimelb.edu.au
authors.forename: Elizabeth V
authors.initials: EV
authors.lastname: Cyarto
authors.forename: Kay L
authors.initials: KL
authors.lastname: Cox
authors.forename: Osvaldo P
authors.initials: OP
authors.lastname: Almeida
authors.forename: Leon
authors.initials: L
authors.lastname: Flicker
authors.forename: David
authors.initials: D
authors.lastname: Ames
authors.forename: Gerard
authors.initials: G
authors.lastname: Byrne
authors.forename: Keith D
authors.initials: KD
authors.lastname: Hill
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Beer
authors.forename: Dina
authors.initials: D
authors.lastname: LoGiudice
authors.forename: Kana
authors.initials: K
authors.lastname: Appadurai
authors.forename: Muireann
authors.initials: M
authors.lastname: Irish
authors.forename: Emma
authors.initials: E
authors.lastname: Renehan
authors.forename: Nicola T
authors.initials: NT
authors.lastname: Lautenschlager
mesh_terms: D000544:Alzheimer Disease / Q000523:psychology*; D002985:Clinical Protocols; D003071:Cognition; D015444:Exercise; D006801:Humans; D012107:Research Design