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The TACIT Trial: TAi ChI for People With demenTia (TACIT)

This study is currently recruiting participants.
Verified April 2017 by Samuel Nyman, Bournemouth University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02864056
First Posted: August 11, 2016
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Southern Health NHS Foundation Trust
Dorset HealthCare University NHS Foundation Trust
Peninsula Clinical Trials Unit
National Institute for Health Research, United Kingdom
University of Southampton
Elemental Tai Chi
Alzheimer's Society
Solent NHS Trust
Information provided by (Responsible Party):
Samuel Nyman, Bournemouth University
  Purpose

This is a two-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 Intervention
Dementia Accidental Falls Other: Tai Chi

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Samuel Nyman, Bournemouth University:

Primary Outcome Measures:
  • Timed Up and Go test [ Time Frame: 6 months from Baseline ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 300
Actual Study Start Date: April 6, 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual care
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.

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 65 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Person with dementia:

  • Aged 65 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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Samuel Nyman, PhD 44 (0)1202 968179 snyman@bournemouth.ac.uk

Locations
United Kingdom
Memory Assessment Service, Dorset HealthCare University Foundation Trust Recruiting
Poole, Dorset, United Kingdom, BH12 4NB
Contact: Kathy Sheret    01202 305746    KATHY.SHERET@dhuft.nhs.uk   
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    joanne.taylor4@solent.nhs.uk   
Memory Assessment and Research Centre, Southern Health NHS Foundation Trust Recruiting
Southampton, Hampshire, United Kingdom, SO30 3JB
Contact: Lena Azbel-Jackson, PhD    02380 475948    Lena.Azbel-Jackson@southernhealth.nhs.uk   
Contact: Brady McFarlane, MD    02380 475948    brady.mcfarlane@southernhealth.nhs.uk   
Sponsors and Collaborators
Bournemouth University
Southern Health NHS Foundation Trust
Dorset HealthCare University NHS Foundation Trust
Peninsula Clinical Trials Unit
National Institute for Health Research, United Kingdom
University of Southampton
Elemental Tai Chi
Alzheimer's Society
Solent NHS Trust
Investigators
Principal Investigator: Samuel Nyman, PhD Bournemouth University
  More Information

Additional Information:
Responsible Party: Samuel Nyman, Dr Samuel Nyman, Bournemouth University
ClinicalTrials.gov Identifier: NCT02864056     History of Changes
Other Study ID Numbers: TACIT001
CDF-2015-08-030 ( Other Grant/Funding Number: National Institute for Health Research )
16/WS/0139 ( Other Identifier: United kingdom Reserach Ethics Committee )
First Submitted: August 5, 2016
First Posted: August 11, 2016
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders