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DementiaTACITNCT02864056

The TACIT Trial: TAi ChI for People With demenTia

A study testing Tai Chi in people with Dementia and Accidental Falls, run by Bournemouth University at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Accidental Falls
What is being tested?
Tai Chi
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
3 sitesUnited Kingdom
Study dates
6 Apr 2017to 1 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Memory Assessment Service, Dorset HealthCare University Foundation Trust

    Poole, Dorset, BH12 4NB

  • Solent NHS Trust

    Portsmouth, Hampshire, PO3 6AD

  • Memory Assessment and Research Centre, Southern Health NHS Foundation Trust

    Southampton, Hampshire, SO30 3JB

Other trials in United Kingdom

About this study

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

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:

Read more
  • 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.
Read the 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.

Being tested
Tai Chi
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai ChiOther

    Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.

Study groups in NCT02864056
Study groupRoleWhat they receive
ControlNo interventionUsual care
Tai ChiExperimentalCompletes 50 hours of Tai Chi, a combination of in-class and at-home practise.
Receives: Other: Tai Chi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timed Up and Go test

    Measured: 6 months from Baseline

Secondary outcomes (10)

  1. Berg Balance Scale (BBS)

    Measured: 6 months from Baseline

  2. Postural sway

    Performance while standing on the floor and on a foam mat

    Measured: 6 months from Baseline

  3. Iconographical Falls Efficacy Scale (Icon-Fes, short form)

    10 item scale of fear of falling

    Measured: 6 months from Baseline

  4. Statue task

    Visual-spatial cognitive functioning using visual scenes on a small handheld tablet

    Measured: 6 months from Baseline

  5. ICEpop CAPability measure for Older people (ICECAP-O)

    Measured: 6 months from Baseline

  6. Number and rate of falls

    Measured: 6 months from Baseline

  7. Number and rate of fallers

    Measured: 6 months from Baseline

  8. Number and rate of injurious falls

    Measured: 6 months from Baseline

  9. Zarit Burden Interview (short-form)

    12 item scale assessing burden on carer

    Measured: 6 months from Baseline

  10. Mini-Addenbrooke's Cognitive Examination (M-ACE)

    Assess global cognitive functioning

    Measured: 6 months from Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study start6 Apr 2017
  3. Primary completion1 Dec 2018
  4. Study completion1 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864056
Sponsor's protocol ID
TACIT001
Other IDs
CDF-2015-08-030, 16/WS/0139
Acronym
TACIT
Status last verified
Dec 2018
First submitted
5 Aug 2016
Last updated
17 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A Data Management Plan will be prepared to facilitate access, sharing and preservation. This will be explicitly referred to in the Statistical Analysis Plan and in the resultant publication of the main trial outcome. This will include specific detail of how potential bona fide research teams will be able to access the following from the CI's institution (Bournemouth University) online repository after an embargo period of approximately 24 months from the publication of the main trial outcome paper.

Publications

  • Bibi I, Polman R, Nyman SR. The Effect of Adherence to a Tai Chi Intervention on Quality of Life of Older People Living With Dementia. J Aging Phys Act. 2025 Jan 3;33(4):359-369. doi: 10.1123/japa.2024-0017. Print 2025 Aug 1.

    PubMed 39753119

  • 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.

    PubMed 36706322

  • 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.

    PubMed 33141417

  • 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.

    PubMed 31819385

  • 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.

    PubMed 30390620

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi in people with Dementia and Accidental Falls, run by Bournemouth University at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go test (time frame: 6 months from Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864056, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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