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临床试验/NCT03341091
NCT03341091已完成不适用

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

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Recruitment rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

An independent assessor who was blinded to group allocation assessed the participants' motor performance variables.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Tai-chi group

Experimental

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.

干预措施: Tai-chi group (Other)

Control group

No Intervention

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.

结局指标

主要结局

Recruitment rate

时间窗: Enrollment date

The number of dyads who provided consent to join the study over the eligible dyads

Participants' adherence to practising Tai-chi at home and in the training sessions

时间窗: Throughout the 16-week programme

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.

Occurrence of adverse events such as falls

时间窗: Throughout the 16-week programme and during the training sessions

Any adverse events at home were recorded.

Attrition rate

时间窗: At the end of the 16-week programme

The attrition rate was indicated by the percentage of dyads withdrawing from the study

次要结局

  • Number of steps recorded in the Step Test(Baseline, 8th week and 16th week from baseline)
  • Time measured in the Timed-up-and-Go test(Baseline, 8th week and 16th week from baseline)
  • Length measured by the Functional Reach test(Baseline, 8th week and 16th week from baseline)
  • Menorah Park Engagement Scale(every week of the 16-week Tai-chi programme)
  • Time measured in the Timed Chair Stand test(Baseline, 8th week and 16th week from baseline)
  • Focus interview groups(17th week from baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Justina Liu Yat Wa

Associate Professor

The Hong Kong Polytechnic University

研究点 (2)

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