Multidomain Interventions for Elderly Individuals in Residential Structures

NCT06820710 | Completed

• 2 other identifiers: 4-2024-SPERIM_ALTRO-CR45982/U6/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

aging; long term care facilities; multidimensional interventions; cognitive training; physical exercise; nutritional intervention; functional foods; vaccinations

Outcome Measures

Primary Outcomes (3)

• Effect of the multidomain intervention on the gut microbiota composition

  Changes in gut microbiota biodiversity measured as species richness (number of different taxa identified in each sample) in the intervention group compared to control group

  Baseline and 3 months after the start of the intervention

• Effect of the multidomain intervention on the gut microbiota composition

  Changes in gut microbiota in term of the most represented bacterial taxa (such as Faecalibacterium prausnitzii, Akkermansia muciniphila, Bifidobacterium spp, Lactobacillus spp; measured as average relative abundance) in the intervention group compared to control group

  Baseline and 3 months after the start of the intervention

• Effect of the multidomain intervention on the gut microbiota composition

  Changes in gut microbiota in terms of gene or transcript counts (measured as counts) in the intervention group compared to control group

  Baseline and 3 months after the start of the intervention

Secondary Outcomes (38)

• Feasibility of the multidomain intervention

  At the end of the intervention (6 months after the start)

• Effect of the multidomain intervention on the gut microbiota composition

  Baseline, 6 and 9 months after the start of the intervention

• Effect of the multidomain intervention on the gut microbiota composition

  Baseline, 6 and 9 months after the start of the intervention

• Effect of the multidomain intervention on the gut microbiota composition

  Baseline, 6 and 9 months after the start of the intervention

• Effect of the multidomain intervention on specific biomarkers

  Baseline, 6 and 9 months after the start of the intervention

Study Arms (2)

Multidomain Intervention group

EXPERIMENTAL

The 6-month intervention will include supervised physical exercises (each session will last 40 minutes, three times a week, with accelerometers and smartwatches to monitor the physical activity performed), and cognitive stimulation (delivered by neuropsychologists twice a week for 30 minutes, in small groups). Participants in the intervention group will be advised to follow a Mediterranean diet, will receive functional foods (sourdough bread fortified with vegetable matrix rich in polyphenols and probiotic artichokes), and will be offered to receive appropriate vaccinations according to the national vaccination calendar.

Other: Physical activity; Other: Cognitive stimulation; Other: Nutritional Intervention; Other: Vaccinations

Control group (usual activities)

NO INTERVENTION

Subjects in the control group will receive general information on healthy lifestyles and health, including risk factors.

Interventions

Physical activity OTHER

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.

Multidomain Intervention group

Cognitive stimulation OTHER

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.

Multidomain Intervention group

Nutritional Intervention OTHER

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.

Multidomain Intervention group

Vaccinations OTHER

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.

Multidomain Intervention group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥70 years;
• resident in the identified LTCFs for at least 6 months;
• able to communicate and collaborate with the research team;
• Mini-Mental State Examination-MMSE ≥18.

You may not qualify if:

• estimated length of stay in the LTCFs\<6 months;
• estimated life expectancy \<6 months;
• previous gastrectomy or colectomy;
• presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG);
• presence of dysphagia;
• inability to undergo psychometric tests for any reason;
• history of psychiatric illness according to clinical anamnesis;
• inability to walk.

Sponsors & Collaborators

• Istituto di Neuroscienze Consiglio Nazionale delle Ricerche: lead

Study Sites (2)

RSA Cremona Solidale

Cremona, Italy, 26100, Italy

Location

AltaVita IRA

Padova, Italy, 35137, Italy

Location

Related Publications (1)

• Romeo Z, Macchia E, Ceolin C, Devita M, Morandi A, Noale M, Maggi S; I-COUNT Study Group. Feasibility and Potential Effects of Multidomain Interventions to Improve the Cognitive and Functional Well-Being of Elderly Individuals in Residential Structures: The I-COUNT Pilot Study Protocol. Healthcare (Basel). 2025 Aug 14;13(16):1999. doi: 10.3390/healthcare13161999.

  PMID: 40868616 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Exercise; Vaccination

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Participants in the "experimental group: multidomain intervention" will undergo the planned interventions for a 6-month period, including physical activity and cognitive training; they will be offered to receive appropriate vaccinations according to the national vaccination calendar, and will be offered functional foods. Participants in the "control group" will be asked to continue with their usual activities.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 11, 2025
• Study Start: February 3, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)