Effects of Enriched Gardens in Nursing Home Residents With Dementia

Not Applicable

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT04903171
• Lead Sponsor: RIVAGES

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-15
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Study First Submitted: 2021-03-03
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-26
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in functional independence	6 MONTHS	Activities of daily living (ADL), 0-6, higher score is the better outcome
Change in global cognitive function	6 MONTHS	Mini Mental Status Examination (MMSE) , 0-30, higher score is the better outcome

Secondary Outcome Measures

Name	Time	Method
Change in balance	6 MONTHS	Unipodal Stance (sec), higher time is the better outcome
Change in gait ability	6 MONTHS	Timed Up and Go test (sec), higher time is the worse outcome

Trial Locations

Locations (1)

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université; 🇫🇷 Ivry-sur-Seine, Val De Marne, France