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临床试验/NCT04436315
NCT04436315Unknown不适用

Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder

Davy Vancampfort2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Cognitive functions

研究概览

简要总结

This study evaluates the feasibility of the intervention and the study design.

详细描述

This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.

研究设计

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

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

  • Aged 60+ years
  • Living in residency "de Wingerd" in Leuven (at least two weeks here)
  • Being able to straight for minimal 10 minutes without aids
  • Visual acuity with correction sufficient to see on a TV screen
  • diagnosed with major neurocognitive disorder

排除标准

  • Mobility impairments that don't allow to play the exergame
  • Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
  • Orthopaedic or neurological diseases that prevent exergame training
  • Rapidly progressive or terminal illness

结局指标

主要结局

Cognitive functions

时间窗: 2 years

Montréal Cognitive Assessment Mini-Mental State Examination

Motor functions

时间窗: 2 years

Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety Short Physical Performance Battery 1 - Minute Sit to Stand Test

Feasibility

时间窗: 2 years

Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety

Mental health

时间窗: 2 years

Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life

次要结局

未报告次要终点

研究者

发起方
Davy Vancampfort
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Davy Vancampfort

Professor

KU Leuven

研究点 (2)

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