Accidental Falls, Dementia
Conditions
Brief summary
This is a three-centre parallel group randomised controlled trial with an embedded process evaluation and intervention pilot phase (details not provided in this summary). The overall research question is: Can a Tai Chi exercise programme prevent falls among people with dementia (PWD), specifically among older PWD living at home? Primary Outcome measure: • dynamic postural balance (as a surrogate for falls). Secondary outcome measures: * to explore the effects of a Tai Chi exercise programme on static and functional postural balance, fear of falling, cognitive functioning, falls, and quality of life. Also to explore the effects of a Tai Chi exercise programme on their informal carer's dynamic and static postural balance, quality of life, and carer burden * to determine the acceptability and safety of the Tai Chi intervention * to inform the design of a future definitive clinical trial.
Detailed description
Amongst people aged over 65, people with dementia (PWD) are much more likely to fall, and be injured, than those without dementia. Being injured from falling over is the main reason why older people attend the hospital A&E department. PWD often experience longer hospital stays following a fall, and may become confused which can be stressful for the carer; and a considerable cost to the NHS. There is evidence that exercise programmes help to prevent falling. Can a Tai Chi exercise programme prevent falls among PWD living at home? We will investigate whether practising Tai Chi over several months improves dynamic postural balance (because it is a good indicator of how likely someone is to fall). People with mild to moderate dementia who live at home are eligible to take part with their regular care-giver as a 'pair'. We will recruit 150 pairs, i.e. 150 people with dementia and their informal caregiver (300 people in total). The PWD must be aged 18 years or older and both must be willing and able to do standing Tai Chi. At baseline, the researcher will visit the pair at home to assess the participants' balance, memory skills, and general well-being. Pairs will be randomly assigned to either Tai Chi and usual care (intervention) or usual care only (control). Pairs in the intervention group will practice Tai Chi together in a weekly group class held locally, and at home, and will complete a diary of how much time was spent doing Tai Chi over six months. All participants will complete diaries showing how often they fell and whether falls caused an injury. The baseline assessment will be repeated at six months. A researcher will collect feedback from the pair to see whether the intervention could be (further) tailored to the need of PWD and carers. The change in ability to balance over six months will be compared between PWD in each group.
Interventions
OTHERTai Chi
Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.
Sponsors
Southern Health NHS Foundation Trust
Dorset HealthCare University NHS Foundation Trust
University of Plymouth
National Institute for Health Research, United Kingdom
University of Southampton
Elemental Tai Chi
Alzheimer's Society
Solent NHS Trust
Bournemouth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Person with dementia: * Aged 18 or above * Living at home * Have a diagnosis of a dementia * Able to do standing Tai Chi (e.g. not be wheelchair bound) * Willing to attend weekly Tai Chi classes * Willing to attend a focus group (intervention pilot phase only) Carer: * Able to commit to supporting the PWD by participating in data collection throughout the study and in the intervention components if allocated to the intervention group (minimum of 2 times per week in-person, but ideally more) * Able to do standing Tai Chi (e.g. not be wheelchair bound) * Willing to attend weekly Tai Chi classes * Willing to attend a focus group (intervention pilot phase only)
Exclusion criteria
Person with dementia * Living in a care home * In receipt of palliative care * Indicate that they have: * Severe dementia * A Lewy body dementia or dementia with Parkinson's disease * Severe sensory impairment * Are already currently practising (on average once a week or more) or have been practising within the past six months (on average once a week or more) Tai Chi or similar exercise (Qigong, yoga, or Pilates) * Are currently under the care of or have been referred to a falls clinic for assessment, or are currently attending a balance exercise programme (e.g. Otago classes) * Lack mental capacity to provide informed consent Carer: * Indicate that they have severe sensory impairment * Lack mental capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timed Up and Go test | 6 months from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postural sway | 6 months from Baseline | Performance while standing on the floor and on a foam mat |
| Iconographical Falls Efficacy Scale (Icon-Fes, short form) | 6 months from Baseline | 10 item scale of fear of falling |
| Statue task | 6 months from Baseline | Visual-spatial cognitive functioning using visual scenes on a small handheld tablet |
| ICEpop CAPability measure for Older people (ICECAP-O) | 6 months from Baseline | — |
| Berg Balance Scale (BBS) | 6 months from Baseline | — |
| Number and rate of fallers | 6 months from Baseline | — |
| Number and rate of injurious falls | 6 months from Baseline | — |
| Zarit Burden Interview (short-form) | 6 months from Baseline | 12 item scale assessing burden on carer |
| Mini-Addenbrooke's Cognitive Examination (M-ACE) | 6 months from Baseline | Assess global cognitive functioning |
| Number and rate of falls | 6 months from Baseline | — |
Countries
United Kingdom
Outcome results
None listed