Title: Developing a sustainable research programme to prevent falls and promote physical activity among older people with dementia.
Funder: Department of Health and Social Care

Abstract: This study will contribute to a developing programme of research to identify the most appropriate and effective approaches for preventing falls and promoting physical activity among people with dementia (PWD). This study will be a phase 2 randomised controlled trial (RCT) to test the effectiveness of Tai Chi to improve postural balance among community-dwelling PWD, and the feasibility of conducting a phase 3 trial. If the results of this study are favourable, then the subsequent study will be a multi-site, phase 3 trial to test the effect of the intervention on preventing falls and associated hospital admissions. Background Falls are the leading cause for A&E presentation in adults aged 65+ [4], and people with dementia (PWD) are twice at risk of falling and twice at risk of sustaining a fall-related injury [8,9]. There is thus a pressing need to reduce the risk of admission of PWD to A&E due to fall-related injury. Existing systematic reviews report robust evidence for exercise-based interventions to prevent falls among community-dwelling older people [35], but the few studies with PWD have shown mixed findings. Tai Chi exercise has been successfully adapted for people with dementia by an American research team. While Tai Chi has been shown to prevent falls, at present, no study has been conducted in the UK, and no study has used a RCT design targeting PWD.CHAR(13) + CHAR(10)This will be the first UK study to test the benefit of Tai Chi exercise for improving balance and preventing falls among PWD. CHAR(13) + CHAR(10)AimsThe overarching research question is, Can a Tai Chi exercise intervention prevent falls among community-dwelling older PWD? This phase 2 trial will test the effectiveness of the intervention on improving postural balance, and the subsequent phase 3 trial will test the effectiveness of the intervention on rate of falls and associated hospital admissions. Plan of investigationThe intervention will comprise three components: (1) Tai Chi classes delivered for 20 weeks, (2) carer-led, home-based Tai Chi exercises, and (3) a behaviour change component to enhance adherence to the intervention. [1] Pre-trial phaseThe protocol for baseline data collection and intervention delivery will be refined through testing with 14 dyads (PWD and their carer) over four weeks. Qualitative data will be captured.[2] Phase 2 RCT 150 PWD and their carers will be recruited from memory clinics and randomised to either an intervention (n=75) or control group (n=75). Baseline measures will be repeated at a six-month post-baseline follow-up, with dynamic balance (timed up and go test) as the primary outcome. Secondary outcome measures will be static balance, fear of falls, daily functioning, mood, agitated behaviour, cognitive functioning, and carer burden. The process evaluation will collect qualitative data through observation of the Tai Chi classes and interviews. Falls experienced, class attendance, and adherence to home-based Tai Chi exercises will be recorded weekly throughout the six month period. Health economics data will also be collected to determine the cost-effectiveness of the intervention in relation to health care service use. Summary of potential benefits to patients and the NHS The intervention is anticipated to benefit PWD by reducing their risk of unwanted hospital stays and admission to a care home. Carers of PWD will benefit by avoiding the stress and increased workload of caring for someone with PWD with a fall-related injury. The NHS will benefit through a reduction in the number of A&E attendances among PWD with a fall-related injury. This will provide cost savings and relieve much needed pressure on UK A&E departments.

Lay abstract: This study will contribute to a developing body of research to identify the most appropriate and effective ways of preventing falls and promoting physical activity among people with dementia. Aims of the research This research project will address the question, Can Tai Chi exercise prevent people with dementia from falling? This is the first in a series of studies that will answer this question. We will first look to see if Tai Chi can improve balance in this study. If it works, then we will go on to do a large study that will test if Tai Chi works in reducing the number of falls experienced by people with dementia. For both studies we will be looking at the benefits of Tai Chi for people living in their own homes. Background to the research Being injured from falling over is the main reason why older people attend accident and emergency (A&E) hospital departments. People with dementia are much more likely to be in A&E due to a fall; they fall twice as much and are injured twice as much as those without dementia. As well as injury, people with dementia often become more confused and agitated while in hospital and their health becomes worse. All of this can be stressful for carers and the cost to the NHS is considerable. A new service is needed for people with dementia to help prevent them from falling. It will help improve their quality of life and their carer's. It will also ease pressure on bursting A&E departments. There is evidence that exercise programmes work in preventing people from falling. However, most studies have not included people with dementia and so it is not clear if it works with these patients. Tai Chi is a promising way of promoting exercise to prevent falls. An American study adapted Tai Chi for people with dementia and found promising results. However, this was a small study with a health system different to the NHS. Our study will be the first in the UK to test if Tai Chi can prevent falls among people with dementia. Design and methods used Our Tai Chi programme will ask participants to come to a class every week for 20 weeks. We will also ask them to do Tai Chi exercises at home, and provide them with help to keep them motivated. Pre-trial phase Fourteen patients and their carer will be invited to try the Tai Chi programme for four weeks. This will check that the Tai Chi programme and study arrangements will work well in the main randomised controlled trial. Randomised controlled trial 150 people with dementia and their carer will take part: 75 people will receive the Tai Chi programme and 75 will receive care as normal from the NHS. At the beginning of the study, each participant will complete some balance tests and questionnaires. Six months later, after either receiving the Tai Chi programme or usual care, we will look to see if Tai Chi improved balance in people with dementia, as well as provide other benefits such as reduce fear of falling. Also, during the study, we will ask carers to fill in calendars to record how much patients have followed the programme, and whether any patients have had a fall. We will observe classes and interview patients and their carers to identify ways of improving the programme, and test if Tai Chi saves the NHS money from fewer visits to the GP, our of hours, or A&E. Patient and public involvement We have already had an in-depth discussion with 6 patients and their carers who have played a key role in developing the research ideas included in this application. For example, based on the group's ideas, Tai Chi will mainly be provided in weekly classes over 20 weeks. From the start of the research project, we will continue to involve these patients and their carers in an advisory group. They will help with aspects such as making information given to patients user friendly. Dissemination With the help of our advisory group, each year we will host an event to raise public awareness of the research. The group will also help present the results to a group of health and social care professionals from across Dorset and develop a 4-page summary of the results that will be freely available online. We will also write summaries for magazines read by dementia care workers and NHS managers, and disseminate the results at scientific meetings and in leading scientific journals.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.7 PHYSICAL
Health categories: NEUROLOGICAL;INJURIES AND ACCIDENTS