Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2017-04-06
2018-12-01
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Usual care
No interventions assigned to this group
Tai Chi
Completes 50 hours of Tai Chi, a combination of in-class and at-home practise.
Tai Chi
Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.
Interventions
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Tai Chi
Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Southern Health NHS Foundation Trust
OTHER
Dorset HealthCare University NHS Foundation Trust
OTHER
University of Plymouth
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Southampton
OTHER
Elemental Tai Chi
UNKNOWN
Alzheimer's Society
OTHER
Solent NHS Trust
OTHER_GOV
Bournemouth University
OTHER
Responsible Party
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Samuel Nyman
Dr Samuel Nyman
Principal Investigators
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Samuel Nyman, PhD
Role: PRINCIPAL_INVESTIGATOR
Bournemouth University
Locations
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Memory Assessment Service, Dorset HealthCare University Foundation Trust
Poole, Dorset, United Kingdom
Solent NHS Trust
Portsmouth, Hampshire, United Kingdom
Memory Assessment and Research Centre, Southern Health NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Countries
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References
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Nyman SR, Casey C, Greenwood N. Hypothesis: Dementia Diminishes Interdependence in Health and Quality of Life Among Spousal Partners. Alzheimer Dis Assoc Disord. 2023 Apr-Jun 01;37(2):174-177. doi: 10.1097/WAD.0000000000000539. Epub 2023 Jan 18. No abstract available.
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.
Other Identifiers
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CDF-2015-08-030
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
16/WS/0139
Identifier Type: OTHER
Identifier Source: secondary_id
TACIT001
Identifier Type: -
Identifier Source: org_study_id