Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial.
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.
Cerga-Pashoja
Arlinda
A
Central & North West London NHS Foundation Trust, Greater London House, Hampstead Rd, London, NW1 7QY, UK.
Lowery
David
D
Bhattacharya
Rahul
R
Griffin
Mark
M
Iliffe
Steve
S
Lee
James
J
Leonard
Claire
C
Ricketts
Sue
S
Strother
Lyn
L
Waters
Fiona
F
Ritchie
Craig W
CW
Warner
James
J
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
Lancet Neurol. 2009 Feb;8(2):151-7
19138567
Arch Phys Med Rehabil. 2004 Oct;85(10):1694-704
15468033
J Am Geriatr Soc. 1994 Mar;42(3):297-302
8120315
JAMA. 2003 Oct 15;290(15):2015-22
14559955
Aging Ment Health. 2008 Jan;12(1):72-80
18297481
Health Technol Assess. 2005 Mar;9(10):1-93, iii-iv
15774233
J Am Geriatr Soc. 1986 Jul;34(7):493-8
3722665
Dement Geriatr Cogn Disord. 2003;15(2):99-105
12566599
Int J Nurs Stud. 1991;28(2):145-51
1894462
Gerontologist. 2001 Oct;41(5):652-7
11574710
Br J Psychiatry. 2002 May;180:411-5
11983637
J Geriatr Psychiatry Neurol. 1995 Jan;8(1):52-60
7710649
Int Psychogeriatr. 1996;8 Suppl 3:497-500
9154615
JAMA. 1982 Jul 16;248(3):333-5
7087127
Neurology. 1994 Dec;44(12):2308-14
7991117
J Public Health (Oxf). 2004 Jun;26(2):138-43
15284315
Am J Psychiatry. 2007 Oct;164(10):1568-76; quiz 1623
17898349