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临床试验/NCT04903171
NCT04903171已完成不适用

Effects of Enriched Gardens on Cognition and Independence of Nursing Home Residents With Dementia: a Cluster-controlled Trial

RIVAGES2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RIVAGES
入组人数
130
试验地点
2
主要终点
Change in functional independence

研究概览

简要总结

Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test)

详细描述

The cluster controlled trial is conducted over a six months period after recruitment of residents from 4 different nursing homes in France. The participants are distributed into 3 groups. One group does not receive incentive from carers to visit any garden, the second group receives incentives to visit regularly a conventional sensory garden and the third group receive incentives from carers to visit regularly an enriched garden. The study is conducted over a period of 6 months. All participants are giving consent to the study. They will be evaluated before and after over 4 different tests. MMSE (Mini Mental Status Examination) for cognitive impairment, ADL (Activity for day Living) for functional autonomy, TUG (Test up and Go) and Unipodal Stance for prevention of falls.

研究设计

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

盲法说明

The investigators and outcomes assessor do not know which groups the participants belongs to

入排标准

年龄范围
75 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Give consent
  • Ability walking alone
  • Alzheimer's disease

排除标准

  • No dementia
  • Severe dementia
  • Severe behavioural disorder
  • Inability to walk alone

结局指标

主要结局

Change in functional independence

时间窗: 6 MONTHS

Activities of daily living (ADL), 0-6, higher score is the better outcome

Change in global cognitive function

时间窗: 6 MONTHS

Mini Mental Status Examination (MMSE) , 0-30, higher score is the better outcome

次要结局

  • Change in balance(6 MONTHS)
  • Change in gait ability(6 MONTHS)

研究者

发起方
RIVAGES
申办方类型
Other
责任方
Sponsor

研究点 (2)

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