Multidomain Interventions for Elderly Individuals in Residential Structures

NCT06820710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-08

No results posted yet for this study

Summary

The "Multidomain Interventions to improve the COgnitive and fUNctional well-being of elderly individuals in residential sTructures" (I-COUNT) study aims to test the feasibility and the effectiveness of a multidisciplinary intervention among elderly individuals living in long term care facilities (LTCFs). The intervention will include selected physical and cognitive training activities administered and monitored by new technologies, a dietary intervention including also functional foods, and the administration of vaccines according to the National plan. The multidomain intervention will last 6 months and will be compared with the standard care adopted in the same LTCFs.

Conditions

  • Aging
  • Age-Related Cognitive Decline
  • Sarcopenia
  • Long Term Care Facility
  • Cognitive Training
  • Physical Exercise
  • Functional Food
  • Nutritional Intervention
  • Vaccinations

Interventions

OTHER

Physical activity

Appropriate exercises for supervised small group sessions will be prescribed by a physiotherapist or expert in exercise science. Each session will last approximately 40 minutes, three times a week, and will be based on the international guidelines for physical exercise in the elderly population, and the VIVIFRAIL Multicomponent Physical Exercise Program to Prevent Frailty and the Risk of Falls. Accelerometers and other wearable sensors (smartwatches) will be used to monitor the physical activity performed.

OTHER

Cognitive stimulation

Cognitive stimulation will be delivered by expert neuropsychologists twice a week (48 sessions in total) for approximately 30 minutes. Residents will be divided into small groups (3-5 people) of similar cognitive level, and the intervention will be delivered using a computerized tool (REmote stimulation for COgnitive DEcline (RECODE) developed by researchers at the University of Padova with the aim of stimulating different domains (i.e., attention, working memory, visual memory, language, orientation and executive functions) through exercises of increasing difficulty.

OTHER

Nutritional Intervention

Participants in the intervention group will be advised to follow a Mediterranean diet and will also receive functional foods; in particular, they will be offered 80 g/day of sourdough bread fortified with vegetable matrix rich in polyphenols (e.g., olive leaves) and 100 g/day of probiotic artichokes on alternate days.

OTHER

Vaccinations

Participants in the intervention group will be offered to receive appropriate vaccinations according to the national vaccination calendar. Vaccine doses will be provided by the Department of Preventive Medicine, Vaccine Office, National Health Service, on prescription from the general practitioners.

Sponsors & Collaborators

  • Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06820710 on ClinicalTrials.gov