Skip to main content
OpenTrials
Completed

NCT Number: NCT02864056

The TACIT Trial: TAi ChI for 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memory Assessment Service, Dorset HealthCare University Foundation Trust, Poole, Dorset, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi

Other

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

Primary outcomes

  1. Timed Up and Go test

    Time frame: 6 months from Baseline

Secondary outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 6 months from Baseline

  2. Postural sway

    Time frame: 6 months from Baseline

    Performance while standing on the floor and on a foam mat

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

    Time frame: 6 months from Baseline

    10 item scale of fear of falling

  4. Statue task

    Time frame: 6 months from Baseline

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

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

    Time frame: 6 months from Baseline

  6. Number and rate of falls

    Time frame: 6 months from Baseline

  7. Number and rate of fallers

    Time frame: 6 months from Baseline

  8. Number and rate of injurious falls

    Time frame: 6 months from Baseline

  9. Zarit Burden Interview (short-form)

    Time frame: 6 months from Baseline

    12 item scale assessing burden on carer

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

    Time frame: 6 months from Baseline

    Assess global cognitive functioning

Sponsors and collaborators

Lead sponsor

Bournemouth University

Other

Collaborators

  • Alzheimer's Society
  • Dorset HealthCare University NHS Foundation Trust
  • Elemental Tai Chi
  • National Institute for Health Research, United Kingdom
  • Solent NHS Trust
  • Southern Health NHS Foundation Trust
  • University of Plymouth
  • University of Southampton

Registry information

Official study 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

Acronym: TACIT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2016
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.