NCT02864056

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

April 6, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

August 5, 2016

Last Update Submit

December 14, 2018

Conditions

DementiaAccidental Falls

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go test

    6 months from Baseline

Secondary Outcomes (10)

  • Berg Balance Scale (BBS)

    6 months from Baseline

  • Postural sway

    6 months from Baseline

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

    6 months from Baseline

  • Statue task

    6 months from Baseline

  • ICEpop CAPability measure for Older people (ICECAP-O)

    6 months from Baseline

  • +5 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Usual care

Tai Chi

EXPERIMENTAL

Completes 50 hours of Tai Chi, a combination of in-class and at-home practise.

Other: Tai Chi

Interventions

Tai ChiOTHER

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

Tai Chi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Memory Assessment Service, Dorset HealthCare University Foundation Trust

Poole, Dorset, BH12 4NB, United Kingdom

Location

Solent NHS Trust

Portsmouth, Hampshire, PO3 6AD, United Kingdom

Location

Memory Assessment and Research Centre, Southern Health NHS Foundation Trust

Southampton, Hampshire, SO30 3JB, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 36706322DERIVED

  • 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.

    PMID: 33141417DERIVED

  • 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.

    PMID: 31819385DERIVED

  • 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.

    PMID: 30390620DERIVED

Related Links

MeSH Terms

Conditions

Dementia

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Samuel Nyman, PhD

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Samuel Nyman

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 11, 2016

Study Start

April 6, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

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.

Locations

GB(3)