Effects of Enriched Gardens in Nursing Home Residents With Dementia

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903171
• Other study ID #: RIVAGES
• Status: Completed
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: May 2021
• Source: RIVAGES
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 95 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN
Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)

Locations

Country	Name	City	State
France	Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université	Ivry-sur-Seine	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
RIVAGES

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in global cognitive function	Mini Mental Status Examination (MMSE) , 0-30, higher score is the better outcome	6 MONTHS
Primary	Change in functional independence	Activities of daily living (ADL), 0-6, higher score is the better outcome	6 MONTHS
Secondary	Change in gait ability	Timed Up and Go test (sec), higher time is the worse outcome	6 MONTHS
Secondary	Change in balance	Unipodal Stance (sec), higher time is the better outcome	6 MONTHS