Effects of Tai-chi Programme on Mobility of People With Dementia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Accidental Falls

Intervention / Treatment
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* Other: Tai-chi group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai-chi group<br>16-week 10-step simplified Tai-chi programme. Two 1-hour sessions of centre-based Tai-chi training and a minimum of three 30-minute Tai-chi sessions at home on a weekly basis. | Other: Tai-chi group<br>* The Tai-chi group received a 16-week 10-step simplified Tai-chi training programme in which additional measures were implemented to enhance participants' engagement.<br>|
| No Intervention: Control group<br>Group recreational activities and continue their usual lifestyles and levels of physical activity as usual for 16 weeks. Two 1-hour sessions of group recreational activities on a weekly basis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | The number of dyads who provided consent to join the study over the eligible dyads | Enrollment date | 
| Attrition rate | The attrition rate was indicated by the percentage of dyads withdrawing from the study | At the end of the 16-week programme | 
| Participants' adherence to practising Tai-chi at home and in the training sessions | Exercise adherence (Tai-chi group only) was assessed by both the exercise diaries and training session attendance. Caregivers were instructed to record participants' adherence in terms of the frequency and duration of their Tai-chi home practice in a weekly exercise diary. | Throughout the 16-week programme | 
| Occurrence of adverse events such as falls | Any adverse events at home were recorded. | Throughout the 16-week programme and during the training sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time measured in the Timed-up-and-Go test | The Timed-up-and-Go test assess mobility of the participants. The time taken by participants to execute the tasks - stand up from a standard chair, walk three meters, turn around, walk back to the chair and sit down - was recorded in seconds. | Baseline, 8th week and 16th week from baseline | 
| Time measured in the Timed Chair Stand test | Timed Chair Stand test assesses functional lower limb muscle strength of the participant. Each participant was instructed to stand up fully and sit down five times as quickly as possible. The time needed to complete this task was recorded. | Baseline, 8th week and 16th week from baseline | 
| Length measured by the Functional Reach test | Functional Reach test assessed the dynamic bilateral stance balance of the participants. Participants stood beside a wall with their dominant arm raised to 90 degrees. They were then instructed to lean forward as far as possible, with the hand remaining at shoulder level. The Functional Reach score was the additional reach of the raised hand from the starting position in centimeters | Baseline, 8th week and 16th week from baseline | 
| Number of steps recorded in the Step Test | The Step Test assesses the dynamic single leg standing balance of the participants. Participants stood with their feet parallel and apart. They were instructed to place one whole foot onto the 5 centimetre-high block in front of them and then return it fully back down to the floor repeatedly as fast as possible, for 15 seconds. Each leg was tested separately, and performance on the side with the least number of steps was the recorded result. | Baseline, 8th week and 16th week from baseline | 
| Focus interview groups | Feedback from participants and their caregivers was collected by focus group within two weeks of completing the Tai-chi programme | 17th week from baseline | 
| Menorah Park Engagement Scale | The engagement of participants with dementia when attending the Tai-chi training sessions was assessed by four items extracted from the Menorah Park Engagement Scale. The four items are constructive engagement, passive engagement, self/other engagement, and non-engagement. Each item was rated on a three-point Likert scale (i.e., 0 = not observed, 1 = up to half the observation, and 2 = more than half of the observation). In addition, Engagement was also rated by the Tai-chi master on a 4-item scale (i.e. engagement during class, following proper steps, satisfaction with participants' learning progress, and satisfaction with participants' performance) based on the Tai-chi instructor's in-class observation. Each item was quantified on a 10-point Likert scale, with higher scores representing a greater degree of engagement. | every week of the 16-week Tai-chi programme | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Dyad approach, Fall prevention, Mobility, Tai-chi