Clinical trial NCT03341091: Effects of Tai-chi Programme on Mobility of People With Dementia
Official title: The Effects of Simplified 10-step Tai-chi Programme on the Motor Performance and Fall Prevention of Community-dwelling Older People With Dementia: a Pilot Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Tai-chi
Dementia
Dyad approach
Fall prevention
Mobility
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel (single-blinded) cluster randomised controlled trial involves two groups of participants (Tai-chi and the control group). Four community health centers that provide dementia care services were recruited through convenience sampling and each was viewed as one cluster and was randomised to either the Tai-chi or the control group, based on computer-generated random numbers. So during the trial, participants in one group receive Tai-chi group programme "in parallel" to participants in the other group, who took part in group recreational activities and continue their usual lifestyles and levels of physical activity.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the feasibility and the preliminary effects of a simplified 10-step Tai-chi programme (a dyadic approach) on the mobility performance of people with mild to moderate dementia.

Four community health centres were recruited and each was randomised to either the intervention group (Tai-chi) or the control group. Tai-chi group received a 16-week 10-step simplified Tai-chi training programme in which additional measures were implemented to enhance participants' engagement. The control group took part in group recreational activities organized by the community centres.

It was hypothesized that the Tai-chi group would outperform the control group regarding their mobility performance.

Detailed description: Four community health centres that provide dementia care services were recruited through convenience sampling. Each was viewed as one cluster and was randomized to either the Tai-chi or the control group, based on computer-generated random numbers prepared by an independent statistician.

Participants allocated to the Tai-chi group took part in the 16-week 10-step simplified Tai-chi programme, which was derived from the traditional Yang style and has been proven to be effective in enhancing older people's balance and mobility. Each week, the dyads attended two 1-hour sessions of centre-based Tai-chi training and practised at least three 30-minute Tai-chi sessions at home. Additional measures targeted cognitively impaired people were implemented to promote engagement, including the adoption of multiple sensory cues, slow and relaxed practice, a dyadic approach, and positive emotional motivation techniques.

Participants allocated to the control group took part in group recreational activities such as watching movies or listening to music, which was organized by the community centres with similar frequency and duration of the Tai-chi sessions that were organized for the Tai-chi group. The control group participants were instructed to continue their usual lifestyles and levels of physical activity.

Eligibility criteria: Inclusion Criteria (for participants with dementia):

* community-dwelling older people aged \> 60 years;
* able to walk independently with no walking aid or no more than a single point stick for at least 10 minutes to ensure their mobility was good enough for taking part in the Tai-chi training;
* formally diagnosed with a form of dementia;
* classified with mild to moderate severity of dementia, assessed by the Montreal Cognitive Assessment 5-minute scale with a cut-off score at the 16th percentile according to participants' age and education; and
* able to identify a caregiver who was willing to work as an exercise partner for their Tai-chi practice.

Inclusion Criteria (for caregivers):

* adults aged \> 18;
* living with the participants or actively involved in their daily care;
* sufficiently mobile to be able to take part in the Tai-chi training together with the participants; and
* willing to work as an exercise partner with the participants and monitor and encourage them to practice Tai-chi at home.

Exclusion Criteria (for participants and caregivers):

if at the time of and three months before recruitment, they

* had any diseases that might severely affect their balance and coordination, such as Parkinson's disease or myasthenia gravis;
* were hospitalized due to acute illnesses such as myocardial infarction, stroke or hip fracture, or had major surgeries;
* reported that they regularly performed moderately intensive exercise, such as hiking or Tai-chi, for more than 2 hours per week;
* had terminal illnesses such as cancer and were in palliative care; or
* had severe visual or hearing impairment.

Primary outcomes:
measure: Recruitment rate
timeFrame: Enrollment date
measure: Attrition rate
timeFrame: At the end of the 16-week programme
measure: Participants' adherence to practising Tai-chi at home and in the training sessions
timeFrame: Throughout the 16-week programme
measure: Occurrence of adverse events such as falls
timeFrame: Throughout the 16-week programme and during the training sessions
Secondary outcomes:
measure: Time measured in the Timed-up-and-Go test
timeFrame: Baseline, 8th week and 16th week from baseline
measure: Time measured in the Timed Chair Stand test
timeFrame: Baseline, 8th week and 16th week from baseline
measure: Length measured by the Functional Reach test
timeFrame: Baseline, 8th week and 16th week from baseline
measure: Number of steps recorded in the Step Test
timeFrame: Baseline, 8th week and 16th week from baseline
measure: Focus interview groups
timeFrame: 17th week from baseline
measure: Menorah Park Engagement Scale
timeFrame: every week of the 16-week Tai-chi programme
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Caritas Hong Kong - Services for the Elderly
city: Hong Kong
country: Hong Kong
facility: H.K.S.K.H. Lok Man Alice Kwok Integrated Service Centre
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yat-wa Justina Liu
role: PRINCIPAL_INVESTIGATOR
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