Multidomain Interventions for Elderly Individuals in Residential Structures

NCT ID: NCT06820710

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-12-31

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.

Detailed Description

I-COUNT is a randomized controlled trial that will be conducted among residents in two residential facilities in Italy. Sixty participants will be enrolled in each residential facility (30 control group, 30 intervention group).

During the first phase of the study, eligible residents of the participating LTCFs will be enrolled according to the following inclusion and exclusion criteria. Baseline evaluations will be based on a geriatric multidimensional assessment including body composition assessment, physical performance assessment, Mediterranean diet adherence assessment, psychological and neuropsychological evaluations. Blood, plasma, stool and urine samples will also be collected.

In phase two, which will last 6 months, participants in the intervention group will undergo the planned interventions, while controls will be asked to continue with their usual activities. The physical activity will consist of three 40-minutes sessions per week, with personalized exercises prescribed by a physiotherapist and performed in small groups, under supervision. The cognitive training will be based on the computer program Remote stimulation for Cognitive Decline (RECODE), developed by the Department of General Psychology, University of the Padua, with two sessions per week. The intervention group will also receive functional foods (sourdough bread enriched with a vegetable matrix rich in polyphenols (olive leaves) and vegetables enriched with probiotics (artichokes)).

In phase 3, participants will be reassessed at 3 months (gut microbiota only), and 6 and 9 months after the start of the intervention (selected biomarkers, nutritional and anthropometric status, psychological health, physical performance tests, cognitive function, acceptability of the technological monitoring and interventions).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Multidomain Intervention group

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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: 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.

Cognitive stimulation

Intervention Type: 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.

Nutritional Intervention

Intervention Type: 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.

Vaccinations

Intervention Type: 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.

Control group (usual activities)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RSA Cremona Solidale

Cremona, Italy, Italy

AltaVita IRA

Padua, Italy, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 40868616 (View on PubMed)

Other Identifiers

5982/U6/24

Identifier Type: OTHER

Identifier Source: secondary_id

4-2024-SPERIM_ALTRO-CR4

Identifier Type: -

Identifier Source: org_study_id