The TACIT Trial: TAi ChI for People With demenTia (TACIT)
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|ClinicalTrials.gov Identifier: NCT02864056|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : May 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia Accidental Falls||Other: Tai Chi||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||April 6, 2017|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
No Intervention: Control
Experimental: Tai Chi
Completes 50 hours of Tai Chi, a combination of in-class and at-home practise.
Other: Tai Chi
Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.
- Timed Up and Go test [ Time Frame: 6 months from Baseline ]
- Berg Balance Scale (BBS) [ Time Frame: 6 months from Baseline ]
- Postural sway [ Time Frame: 6 months from Baseline ]Performance while standing on the floor and on a foam mat
- Iconographical Falls Efficacy Scale (Icon-Fes, short form) [ Time Frame: 6 months from Baseline ]10 item scale of fear of falling
- Statue task [ Time Frame: 6 months from Baseline ]Visual-spatial cognitive functioning using visual scenes on a small handheld tablet
- ICEpop CAPability measure for Older people (ICECAP-O) [ Time Frame: 6 months from Baseline ]
- Number and rate of falls [ Time Frame: 6 months from Baseline ]
- Number and rate of fallers [ Time Frame: 6 months from Baseline ]
- Number and rate of injurious falls [ Time Frame: 6 months from Baseline ]
- Zarit Burden Interview (short-form) [ Time Frame: 6 months from Baseline ]12 item scale assessing burden on carer
- Mini-Addenbrooke's Cognitive Examination (M-ACE) [ Time Frame: 6 months from Baseline ]Assess global cognitive functioning
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864056
|Contact: Samuel Nyman, PhD||44 (0)1202 firstname.lastname@example.org|
|Memory Assessment Service, Dorset HealthCare University Foundation Trust||Recruiting|
|Poole, Dorset, United Kingdom, BH12 4NB|
|Contact: Claire Bradbury 01202 305746 CLAIRE.BRADBURY@dhuft.nhs.uk|
|Solent NHS Trust||Recruiting|
|Portsmouth, Hampshire, United Kingdom, PO3 6AD|
|Contact: Kayode Osanaiye 02392 684683 Kayode.Osanaiye@solent.nhs.uk|
|Contact: Jo Taylor 02392 685295 email@example.com|
|Memory Assessment and Research Centre, Southern Health NHS Foundation Trust||Recruiting|
|Southampton, Hampshire, United Kingdom, SO30 3JB|
|Contact: Marek Czeladzki 02380 475943 Marek.Czeladzki@southernhealth.nhs.uk|
|Contact: Brady McFarlane, MD 02380 475948 firstname.lastname@example.org|
|Principal Investigator:||Samuel Nyman, PhD||Bournemouth University|