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临床试验/NCT05422495
NCT05422495Unknown不适用

Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Executive functions assessed by the TMT A AND B

研究概览

简要总结

Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Many scientific data suggest that regular physical activity has significant and long-lasting beneficial effects on the health of the elderly and is associated with better functional status, a lower risk of falls and improved cognitive functions. However, the attraction to physical activity fades over the years and the reasons mentioned by the elderly for a low practice of physical activity are multiple, the main one being the worsening of their state of health.

The objective of this study is therefore to evaluate the impact of playful, motivating mobility training, stimulating both mobility and cognition, for 8 weeks, on the balance and mobility of elderly people in EHPAD, in particular in conditions of dual-task well known to be at high risk of falling, as well as on the prevention of falls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

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

  • Subjects aged over 60, residing in nursing homes
  • Subjects able to walk 15 meters unaided
  • MMSE > 10
  • Visual acuity in both eyes > 6/10
  • Affiliated subject or beneficiary of a social security scheme
  • Subject having given and signed an informed consent to participate in the study, or his/her guardian
  • Subject having a sedentary activity or practicing a usual light to moderate physical activity (physical activities < 6 METs)

排除标准

  • Subject with a parkinsonian syndrome, any impairment of the motor neuron, pain limiting the practice of physical activity
  • Subject with a modification of less than 3 months of psychotropic drugs
  • Subject practicing high intensity physical activity (> 6 METs)

结局指标

主要结局

Executive functions assessed by the TMT A AND B

时间窗: change between baseline and 6 month

Timed Up and Go (TUG)

时间窗: change between baseline and 6 month

MMSE globale cognitive assesment

时间窗: change between baseline and 6 month

Attention assessed by WAIS digit spans

时间窗: change between baseline and 6 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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