The TACIT Trial: TAi ChI for People With demenTia

Dementia Clinical Trial

— TACIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864056
• Other study ID #: TACIT001
• Secondary ID: CDF-2015-08-0301
• Status: Completed
• Phase: N/A
• Start date: April 6, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Bournemouth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Falls
• Dementia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (9)

Lead Sponsor	Collaborator
Bournemouth University	Alzheimer's Society, Dorset HealthCare University NHS Foundation Trust, Elemental Tai Chi, National Institute for Health Research, United Kingdom, Peninsula Clinical Trials Unit, Solent NHS Trust, Southern Health NHS Foundation Trust, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go test		6 months from Baseline
Secondary	Berg Balance Scale (BBS)		6 months from Baseline
Secondary	Postural sway	Performance while standing on the floor and on a foam mat	6 months from Baseline
Secondary	Iconographical Falls Efficacy Scale (Icon-Fes, short form)	10 item scale of fear of falling	6 months from Baseline
Secondary	Statue task	Visual-spatial cognitive functioning using visual scenes on a small handheld tablet	6 months from Baseline
Secondary	ICEpop CAPability measure for Older people (ICECAP-O)		6 months from Baseline
Secondary	Number and rate of falls		6 months from Baseline
Secondary	Number and rate of fallers		6 months from Baseline
Secondary	Number and rate of injurious falls		6 months from Baseline
Secondary	Zarit Burden Interview (short-form)	12 item scale assessing burden on carer	6 months from Baseline
Secondary	Mini-Addenbrooke's Cognitive Examination (M-ACE)	Assess global cognitive functioning	6 months from Baseline

External Links

•   Trial webpage