Protocol for the TACIT trial (TAi ChI for people with demenTia): 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

Authors: Nyman, S.R., Hayward, C., Thomas, P., Thomas, S., Vassallo, M., Raftery, J. and Allen, H.

Start date: 16 September 2016

Introduction People with dementia (PWD) are more at risk of falling and experiencing injurious falls. However, there is a lack of evidence for interventions to prevent falls among PWD. The aim of this trial is to test the effectiveness of a Tai Chi intervention to improve dynamic balance among community-dwelling PWD aged 65+, and the feasibility of a subsequent definitive trial to test its effectiveness in preventing falls.

Method After an intervention pilot phase, we will conduct a two-centre, parallel group, randomised controlled trial (RCT) with an embedded process evaluation. In the RCT, 150 community-dwelling dyads (PWD and their informal carer) will receive usual care or usual care plus Tai Chi delivered by a qualified instructor for 20 weeks. Tai Chi will be taught in classes (1 hour per week, with up to 10 dyads per class) and practised at home (to be facilitated by the carer, with the support of a home visit from the Tai Chi instructor in week 1-2 of the intervention). Participation will be supported with reminders for both class attendance (telephone calls by the research team) and to carry out the exercises at home (provision of an alarm clock). The primary outcome will be dynamic balance at the six-month post-baseline follow-up, measured using the Timed Up and Go test. Several secondary outcomes will be assessed including the rate of falls prospectively recorded during the 6-month trial period.

Results The project is currently under review by the NHS Research Ethics and Health Research Authority. Recruitment into the intervention pilot phase is expected in the autumn of 2016, and the results of the trial are expected in the autumn of 2018.

Conclusion This trial will provide new evidence for the effectiveness of Tai Chi to improve balance and the feasibility of a future definitive trial.

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