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NCT Number: NCT06754202

Silver Agri Age: Longevity, Intrinsic Capacity and Cognitive Impairment Into Farmlands and Natural Environments: Updating Contexts Following the "Montessori" Action

This project aims to enhance the intrinsic capacities of elderly individuals with mild cognitive impairment by promoting innovative activities based on the Montessori approach within the context of agricultural multifunctionality.

By selecting a rural environment with educational characteristics, we aim to involve individuals with mild cognitive deficits and their families in a personalized therapeutic journey. Through various activities, including horticulture, pet therapy, occupational therapies, sensory and food laboratories, we stimulate cognitive and motor skills, promoting a healthy and balanced lifestyle

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INRCA Hospital, Ancona, Italy

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About this study

Promoting innovative activities following the "Montessori" action in the context of the agricultural multifunctionality, in order to leverage the intrinsic capacity in older people with cognitive impairment.

  • Identifying a rural environment with educational features.
  • Identifying individuals with mild cognitive impairments and relations with their families.
  • Outlining individual therapeutic goals for each participant through different activities:

horticulture, pet therapy, occupational therapies, sensory laboratories, functional food laboratories for a healthy and balanced diet suitable for the first symptoms of dementia, physical activity and continuous social activity between different generations.

  • Horticulture, pet therapy, occupational therapy, sensory labs, physical activity, and social activities IN CONTINUITY between different generations.
  • Spreading the results to a wide National and International audience.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of mild cognitive impairment (MCI);
  • Mini Mental State Examination ≥ 24;
  • ability and willingness to sign informed consent

Exclusion criteria

  • Mini Mental State Examination < 24;
  • severe visual impairment;
  • inability to walk without help or assistance, Tinetti's scale <20

Treatment and study plan

Social activities with cognitive stimulation

Other

The nine-month program will include social activities following the "Montessori" action in the context of the agricultural multifunctionality such as horticulture, pet therapy, occupational therapy, sensory labs, physical activity held three days a week for five hours each day.

Primary outcomes

  1. Changes in the positive and negative affects

    Time frame: At baseline and after 9 months

    The PANAS (Positive and Negative Affect Schedule) produces two distinct dimensions of affect: Positive Affect (PA): Measures emotions like joy, interest, excitement, and enthusiasm and Negative Affect (NA): Measures emotions like fear, anger, sadness, and guilt. Participants rate each of the 20 items (10 for PA, 10 for NA) on a 5-point scale (from 1 = "Very slightly or not at all" to 5 = "Extremely"). The possible score range for both PA and NA is 10 to 50.

    Higher scores indicate higher levels of that particular affect Scores for each subscale are calculated by summing the ratings for the corresponding items.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Rita Bonfigli, PhD

CONTACT

[email protected]

00390718003719

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Collaborators

  • Regione Marche

Registry information

Acronym: Silver Agri Ag

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

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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