The TACIT Trial: TAi ChI for People With demenTia

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial Comparing the Effectiveness of Tai Chi Alongside Usual Care With Usual Care Alone on the Postural Balance of Community-dwelling People With Dementia

Conditions
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Dementia, Accidental Falls

Intervention / Treatment
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* Other: Tai Chi


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Tai Chi<br>Completes 50 hours of Tai Chi, a combination of in-class and at-home practise. | Other: Tai Chi<br>* Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test |  | 6 months from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale (BBS) |  | 6 months from Baseline | 
| Postural sway | Performance while standing on the floor and on a foam mat | 6 months from Baseline | 
| Iconographical Falls Efficacy Scale (Icon-Fes, short form) | 10 item scale of fear of falling | 6 months from Baseline | 
| Statue task | Visual-spatial cognitive functioning using visual scenes on a small handheld tablet | 6 months from Baseline | 
| ICEpop CAPability measure for Older people (ICECAP-O) |  | 6 months from Baseline | 
| Number and rate of falls |  | 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) | 12 item scale assessing burden on carer | 6 months from Baseline | 
| Mini-Addenbrooke's Cognitive Examination (M-ACE) | Assess global cognitive functioning | 6 months from Baseline |