Physical activity programmes for community dwelling people with mild to moderate dementia

Study Code / Acronym
(DAPA - Dementia And Physical Activity
Award Number
09/80/04
Programme
Health Technology Assessment
Status / Stage
Completed
Dates
2 April 2012 -
1 April 2017
Duration (calculated)
04 years 11 months
Funder(s)
NIHR
Funding Amount
£1,705,998.07
Funder/Grant study page
NIHR
Contracted Centre
University of Warwick
Contracted Centre Webpage
Principal Investigator
Professor Sarah Lam
PI ORCID
0000-0003-4349-7195
WHO Catergories
Development of novel therapies
Disease Type
Mild Dementia
Moderate Dementia

CPEC Review Info
Reference ID54
ResearcherReside Team
Published12/06/2023

Data

Study Code / Acronym(DAPA - Dementia And Physical Activity
Award Number09/80/04
Status / StageCompleted
Start Date20120402
End Date20170401
Duration (calculated) 04 years 11 months
Funder/Grant study pageNIHR
Contracted CentreUniversity of Warwick
Contracted Centre Webpage
Funding Amount£1,705,998.07

Abstract

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 Alzheimer's 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.

Plain English Summary

The objectives of the DAPA trial are to undertake a definitive randomised controlled trial to estimate the effects of an exercise/physical activity intervention that is feasible for delivery within the current constraints of National Health Service delivery. We have a proven exercise programme which has been tested in older people, with and without dementia, living in residential care homes. This intervention will be refined for this study, and we will investigate its effects on outcomes that are important to patients. We will also identify ways in which we can promote continued physical activity after the structured exercise programme. The trial will be testing the DAPA exercise programme. The trial is made up of two groups; half the people in the trial will continue with their current services and the other half will take part in the DAPA exercise programme as well as their current services. The DAPA exercise programme will consist of exercise classes to be held twice a week in a local venue for 4 months. A specially trained physiotherapist and one assistant will take each class. The exercises will be done for about 1 hour and participants will exercise at a level to improve muscle strength, fitness and balance. Everyone taking part in the classes will be encouraged to do at least another hour of exercise a week outside of the classes, according to choice, e.g. walking, swimming, cycling, dancing, and/or simply a set of exercises similar to those learnt in the classes. Once the 4 months of classes have been completed, everyone will be encouraged to continue exercising regularly at home or in the community for the next 8 months. Those who take part in the study will have a short assessment with a researcher which will consist of a series of questions and observations to measure memory, thinking abilities, quality of life, mood and physical abilities After this assessment, participants will be told if they have been selected to take part in the exercise programme. If they have not been selected to take part in the exercise programme they will continue with their current services and will have another short assessment with a researcher after 6 months and 12 months.