Multidomain Interventions for Elderly Individuals in Residential Structures (I-COUNT)

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06820710

4-2024-SPERIM_ALTRO-CR4

5982/U6/24 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

Multidomain Intervention group

Experimental group

Description:

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.

Treatment:

Other: Physical activity

Other: Vaccinations

Other: Cognitive stimulation

Other: Nutritional Intervention

Control group (usual activities)

No Intervention group

Description:

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