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

December 30, 2024 updated by: Istituto Nazionale di Ricovero e Cura per Anziani

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Ancona, Italy, 60127
        • Recruiting
        • INRCA Hospital
        • Contact:
          • Anna Rita Bonfigli
          • Phone Number: 0718003719
        • Principal Investigator:
          • Cristina Gagliardi, MsC
      • Fermo, Italy, 63900
        • Recruiting
        • INRCA Hospital
        • Contact:
          • Anna Rita Bonfigli
          • Phone Number: 0718003719
        • Principal Investigator:
          • Cinzia Giuli, Psych

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Subjects with mild cognitive impairment (MCI)
Subjects with mild cognitive oimpairment (MCI) and self-sufficient in mobility that agreed to partecipate in various activities in rural enviroment.
Other: Social activities with cognitive stimulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and after 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Nazionale di Ricovero e Cura per Anziani

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regione Marche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Cristina Gagliardi, MsC, Irccs Inrca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INRCA_005_2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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