- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02864056
The TACIT Trial: TAi ChI for People With demenTia (TACIT)
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
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dorset
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Poole, Dorset, United Kingdom, BH12 4NB
- Memory Assessment Service, Dorset HealthCare University Foundation Trust
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO3 6AD
- Solent NHS Trust
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Southampton, Hampshire, United Kingdom, SO30 3JB
- Memory Assessment and Research Centre, Southern Health NHS Foundation Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Usual care
|
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Experimental: Tai Chi
Completes 50 hours of Tai Chi, a combination of in-class and at-home practise.
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Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Timed Up and Go test
Time Frame: 6 months from Baseline
|
6 months from Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale (BBS)
Time Frame: 6 months from Baseline
|
6 months from Baseline
|
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Postural sway
Time Frame: 6 months from Baseline
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Performance while standing on the floor and on a foam mat
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6 months from Baseline
|
Iconographical Falls Efficacy Scale (Icon-Fes, short form)
Time Frame: 6 months from Baseline
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10 item scale of fear of falling
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6 months from Baseline
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Statue task
Time Frame: 6 months from Baseline
|
Visual-spatial cognitive functioning using visual scenes on a small handheld tablet
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6 months from Baseline
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ICEpop CAPability measure for Older people (ICECAP-O)
Time Frame: 6 months from Baseline
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6 months from Baseline
|
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Number and rate of falls
Time Frame: 6 months from Baseline
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6 months from Baseline
|
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Number and rate of fallers
Time Frame: 6 months from Baseline
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6 months from Baseline
|
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Number and rate of injurious falls
Time Frame: 6 months from Baseline
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6 months from Baseline
|
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Zarit Burden Interview (short-form)
Time Frame: 6 months from Baseline
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12 item scale assessing burden on carer
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6 months from Baseline
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Mini-Addenbrooke's Cognitive Examination (M-ACE)
Time Frame: 6 months from Baseline
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Assess global cognitive functioning
|
6 months from Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Samuel Nyman, PhD, Bournemouth University
Publications and helpful links
General Publications
- Williams J, Nyman S. A secondary analysis of a randomised controlled trial to investigate the effect of Tai Chi on the instrumented timed up and go test in people with mild to moderate dementia. Aging Clin Exp Res. 2021 Aug;33(8):2175-2181. doi: 10.1007/s40520-020-01741-7. Epub 2020 Nov 3.
- Nyman SR, Ingram W, Sanders J, Thomas PW, Thomas S, Vassallo M, Raftery J, Bibi I, Barrado-Martin Y. Randomised Controlled Trial Of The Effect Of Tai Chi On Postural Balance Of People With Dementia. Clin Interv Aging. 2019 Nov 19;14:2017-2029. doi: 10.2147/CIA.S228931. eCollection 2019.
- Nyman SR, Hayward C, Ingram W, Thomas P, Thomas S, Vassallo M, Raftery J, Allen H, Barrado-Martin Y. 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: protocol for the TACIT trial (TAi ChI for people with demenTia). BMC Geriatr. 2018 Nov 3;18(1):263. doi: 10.1186/s12877-018-0935-8.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TACIT001
- CDF-2015-08-030 (Other Grant/Funding Number: National Institute for Health Research)
- 16/WS/0139 (Other Identifier: United kingdom Reserach Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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