Effects of Enriched Gardens in Nursing Home Residents With Dementia

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

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)

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Ivry-sur-Seine, Val De Marne, France, 94200
      • Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: GROUP ONE; The participants do not receive incentive to visit any gardens
Placebo Comparator: GROUP TWO; The participants receive incentives by carers to visit regularly a conventional sensory garden	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)
Experimental: GROUP THREE; The participants receive incentives by carers to visit regularly an enriched garden	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RIVAGES

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer; Enriched garden; Enriched environment; Cognitive impairment; Functional autonomy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: RIVAGES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will only be available to study reviewers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No