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临床试验/NCT02864056
NCT02864056已完成不适用

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

Bournemouth University6 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2017年4月6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
172
试验地点
6
主要终点
Timed Up and Go test

研究概览

简要总结

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.

详细描述

Amongst people aged over 65, people with dementia (PWD) are much more likely to fall, and be injured, than those without dementia. Being injured from falling over is the main reason why older people attend the hospital A&E department. PWD often experience longer hospital stays following a fall, and may become confused which can be stressful for the carer; and a considerable cost to the NHS.

There is evidence that exercise programmes help to prevent falling. Can a Tai Chi exercise programme prevent falls among PWD living at home? We will investigate whether practising Tai Chi over several months improves dynamic postural balance (because it is a good indicator of how likely someone is to fall). People with mild to moderate dementia who live at home are eligible to take part with their regular care-giver as a 'pair'. We will recruit 150 pairs, i.e. 150 people with dementia and their informal caregiver (300 people in total). The PWD must be aged 18 years or older and both must be willing and able to do standing Tai Chi.

At baseline, the researcher will visit the pair at home to assess the participants' balance, memory skills, and general well-being. Pairs will be randomly assigned to either Tai Chi and usual care (intervention) or usual care only (control).

Pairs in the intervention group will practice Tai Chi together in a weekly group class held locally, and at home, and will complete a diary of how much time was spent doing Tai Chi over six months.

All participants will complete diaries showing how often they fell and whether falls caused an injury.

研究设计

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

入排标准

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

入选标准

  • 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)
  • 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)

排除标准

  • 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
  • Indicate that they have severe sensory impairment
  • Lack mental capacity to provide informed consent

研究组 & 干预措施

Control

No Intervention

Usual care

Tai Chi

Experimental

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

干预措施: Tai Chi (Other)

结局指标

主要结局

Timed Up and Go test

时间窗: 6 months from Baseline

次要结局

  • Postural sway(6 months from Baseline)
  • Mini-Addenbrooke's Cognitive Examination (M-ACE)(6 months from Baseline)
  • Zarit Burden Interview (short-form)(6 months from Baseline)
  • Berg Balance Scale (BBS)(6 months from Baseline)
  • ICEpop CAPability measure for Older people (ICECAP-O)(6 months from Baseline)
  • Number and rate of falls(6 months from Baseline)
  • Iconographical Falls Efficacy Scale (Icon-Fes, short form)(6 months from Baseline)
  • Statue task(6 months from Baseline)
  • Number and rate of fallers(6 months from Baseline)
  • Number and rate of injurious falls(6 months from Baseline)

研究者

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

Samuel Nyman

Dr Samuel Nyman

Bournemouth University

研究点 (6)

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