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Completed

NCT Number: NCT04903171

Effects of Enriched Gardens in Nursing Home Residents With Dementia

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)

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

75 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN

Other

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

Primary outcomes

  1. Change in global cognitive function

    Time frame: 6 MONTHS

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

  2. Change in functional independence

    Time frame: 6 MONTHS

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

Secondary outcomes

  1. Change in gait ability

    Time frame: 6 MONTHS

    Timed Up and Go test (sec), higher time is the worse outcome

  2. Change in balance

    Time frame: 6 MONTHS

    Unipodal Stance (sec), higher time is the better outcome

Sponsors and collaborators

Lead sponsor

RIVAGES

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 26, 2021
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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