title: Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial.
abstract: BACKGROUND
  Almost all of the 820,000 people in the UK with dementia will experience Behavioural and Psychological Symptoms of Dementia (BPSD). However, research has traditionally focused on treating cognitive symptoms, thus neglecting core clinical symptoms that often have a more profound impact on living with dementia. Recent evidence (Kales et al, 2007; Ballard et al, 2009) indicates that the popular approach to managing BPSD - prescription of anti-psychotic medication - can increase mortality and the risk of stroke in people with dementia as well as impair quality of life and accelerate cognitive decline. Consequently, there is a need to evaluate the impact that non-pharmacological interventions have on BPSD; we believe physical exercise is a particularly promising approach.
  
  
  METHODS
  We will carry out a pragmatic, randomised, single-blind controlled trial to evaluate the effectiveness of exercise (planned walking) on the behavioural and psychological symptoms of individuals with dementia. We aim to recruit 146 people with dementia and their carers to be randomized into two groups; one will be trained in a structured, tailored walking programme, while the other will continue with treatment as usual. The primary outcome (BPSD) will be assessed with the Neuropsychiatric Inventory (NPI) along with relevant secondary outcomes at baseline, 6 and 12 weeks.
  
  
  CONCLUSIONS
  Designing this study has been challenging both ethically and methodologically. In particular to design an intervention that is simple, measurable, safe, non-invasive and enjoyable has been testing and has required a lot of thought. Throughout the design, we have attempted to balance methodological rigour with study feasibility. We will discuss the challenges that were faced and overcome in this paper.
  
  
  BACKGROUND
  ISRCTN01423159.
authors.affiliation: Central & North West London NHS Foundation Trust, Greater London House, Hampstead Rd, London, NW1 7QY, UK.
authors.forename: Arlinda
authors.initials: A
authors.lastname: Cerga-Pashoja
authors.forename: David
authors.initials: D
authors.lastname: Lowery
authors.forename: Rahul
authors.initials: R
authors.lastname: Bhattacharya
authors.forename: Mark
authors.initials: M
authors.lastname: Griffin
authors.forename: Steve
authors.initials: S
authors.lastname: Iliffe
authors.forename: James
authors.initials: J
authors.lastname: Lee
authors.forename: Claire
authors.initials: C
authors.lastname: Leonard
authors.forename: Sue
authors.initials: S
authors.lastname: Ricketts
authors.forename: Lyn
authors.initials: L
authors.lastname: Strother
authors.forename: Fiona
authors.initials: F
authors.lastname: Waters
authors.forename: Craig W
authors.initials: CW
authors.lastname: Ritchie
authors.forename: James
authors.initials: J
authors.lastname: Warner
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017028:Caregivers / Q000523:psychology*; D003704:Dementia / Q000523:psychology* / Q000628:therapy*; D005081:Exercise Therapy; D006801:Humans; D009483:Neuropsychological Tests; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D016138:Walking
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