Lamb, Sarah
University of Warwick
United Kingdom
Physical activity programmes for community dwelling people with mild to moderate dementia (DAPA - Dementia And Physical Activity)
NIHR
2,363,939
01/04/2012
5.0
Alzheimer's disease & other dementias
Design: Multi-centred, individually randomised controlled trial preceded by an updated systematic review and pilot study. Randomisation will be stratified by centre and dementia severity (mild/moderate). Setting: NHS Community Dementia Services (CDSs). We have selected CDSs as they deal with the majority of people with dementia. Potential participants will be identified from seven CDSs located within Coventry & Warwickshire Partnership Trust, and Oxfordshire & Buckinghamshire Mental Health Foundation Trust. The intervention will be delivered in the community, e.g. day centres. Target population: People with probable dementia (DSMIV criteria) of mild or moderate severity (MMSE >10), who live in the community and have no contra-indication for exercise and increased physical activity. We will exclude people if they have limited life expectancy (<12 months), severe dementia (MMSE <10) or live in residential care homes Health technologies being assessed: Usual care plus a structured exercise and physical activity intervention programme compared to usual care alone. All participants will receive care as usual from the CDS they attend, which will be consistent with NICE clinical guidance, i.e. support in the community, drug and non-drug treatments, integration of care across health, social care and voluntary sectors, and regular review, usually 6-monthly. The structured exercise programme will be delivered to groups of up to 14 participants, in two, 1-hour weekly sessions over 4 months, supplemented with at-home, between-session exercises. We will refine and use our existing manualised exercise programme (OPERA: HTA 06/02/01), which was designed to increase cerebral blood flow and improve overall function, both hypothesised mechanisms by which exercise improves outcomes in dementia. Physiotherapists, supported by technical assistants, will deliver the exercise programme since they have good experience of the attentional and behavioural problems posed by people with dementia, expertise where groups have diverse and challenging needs. Although supervised exercise is the safest and most effective method, we recognise the need to transfer people to sustainable programmes of activity or exercise either in the community (where these can be sourced) or involving carers. This will be built into the intervention. Measurement of costs and outcomes: We have selected outcomes that are important to patients, and recommended for inclusion in dementia trials by international consensus. Data will be collected by face-to-face interview in the patient's home, or another setting if preferred, by blinded research nurses at pre-randomisation baseline, 6 months (primary endpoint) and, to assess longer-term effects, 12 months. The primary outcomes will be dementia severity measured with the Standardised Mini Mental State Examination (sMMSE). Secondary outcome measures include the Bristol Activities of Daily Living Scale (BADLS), Quality of Life in Alzheimers disease (QoL-AD) and the carer- focussed Zarit Burden Interview (ZBI). Resource use will include NHS, social and personal resource use in the year after randomisation (using the Client Service Receipt Inventory to collect data from patients, carers and medical records). The primary economic analysis will take a health care perspective, following guidance for the conduct of health economic analyses specified by NICE. EQ-5D will be used to estimate quality-adjusted life years.