Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial

Trials. 2010;11(1):53 DOI 10.1186/1745-6215-11-53

 

Journal Homepage

Journal Title: Trials

ISSN: 1745-6215 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Medicine (General)

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS


Leonard Claire

Lee James

Iliffe Steve

Griffin Mark

Bhattacharya Rahul

Lowery David

Cerga-Pashoja Arlinda

Ricketts Sue

Strother Lyn

Waters Fiona

Ritchie Craig W

Warner James

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 15 weeks

 

Abstract | Full Text

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>ISRCTN01423159</p>