NCT04903171

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

March 3, 2021

Last Update Submit

May 21, 2021

Conditions

Alzheimer Disease

Keywords

AlzheimerEnriched gardenEnriched environmentDementiaCognitive impairmentFunctional autonomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in gait ability

    6 MONTHS

  • Change in balance

    6 MONTHS

Study Arms (3)

GROUP ONE

NO INTERVENTION

The participants do not receive incentive to visit any gardens

GROUP TWO

PLACEBO COMPARATOR

The participants receive incentives by carers to visit regularly a conventional sensory garden

Other: INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN

GROUP THREE

EXPERIMENTAL

The participants receive incentives by carers to visit regularly an enriched garden

Other: INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN

Interventions

INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDENOTHER

Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)

GROUP THREEGROUP TWO

Eligibility Criteria

Age75 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université

Ivry-sur-Seine, Val De Marne, 94200, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigators and outcomes assessor do not know which groups the participants belongs to
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Cluster controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

May 26, 2021

Study Start

March 15, 2020

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

IPD will only be available to study reviewers

Locations

FR(1)