Multidomain Interventions for Elderly Individuals in Residential Structures

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06820710
• Lead Sponsor: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

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).

Study Timeline

• Study First Submitted: 2025-01-28
• Study Start: 2025-02-03
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of the multidomain intervention on the gut microbiota composition	Baseline and 3 months after the start of the intervention	Changes in gut microbiota in terms of gene or transcript counts (measured as counts) in the intervention group compared to control group

Secondary Outcome Measures

Name	Time	Method
Effect of the multidomain intervention on specific biomarkers of aging	Baseline, 6 and 9 months after the start of the intervention	Changes in ghrelin (measured in pg/mL) in the intervention group compared to control group
Feasibility of the multidomain intervention	At the end of the intervention (6 months after the start)	Number of drop out (number) in the intervention group compared to control group
Effect of the multidomain intervention on the gut microbiota composition	Baseline, 6 and 9 months after the start of the intervention	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
Effect of the multidomain intervention on specific biomarkers	Baseline, 6 and 9 months after the start of the intervention	Changes in FT4 (measured in ng/dL) in the intervention group compared to control group
Effect of the multidomain intervention on the nutritional status	Baseline, 6 and 9 months after the start of the intervention	Changes in Mini Nutritional Assessment (MNA, score 0-30, a higher score indicates a better outcome) in the intervention group compared to control group
Effect of the multidomain intervention on anthropometric status and body composition	Baseline, 6 and 9 months after the start of the intervention	Changes in mid-upper arm circumference (measured in cm) in the intervention group compared to control group
Effect of the multidomain intervention on upper limb strength	Baseline, 6 and 9 months after the start of the intervention	Changes in upper limb strength evaluated with electronic hand dynamometers (measured in kg) in the intervention group compared to control group
Effect of the multidomain intervention on general and domain-specific cognitive functioning	Baseline, 6 and 9 months after the start of the intervention	Changes in the Addenbrooke's Cognitive Examination (ACE-R, minimum 0, maximum 10, a higher score indicate a better outcome) in the intervention group compared to control group
Effect of the multidomain intervention on physical performance	Baseline, 6 and 9 months after the start of the intervention	Changes in the Short Physical Performance Battery (SPPB, minimum 0, maximum 12, a higher score indicates a better outcome) in the intervention group compared to control group
Effect of the multidomain intervention on psychological health	Baseline, 6 and 9 months after the start of the intervention	Changes in the Depression Anxiety Stress Scale (DASS-21, minimum score 0, maximum score 63, a higher score indicates worse outcome) in the intervention group compared to control group
Effect of the multidomain intervention on quality of life	Baseline, 6 and 9 months after the start of the intervention	Changes in the World Health Organization Quality of Life Scale (WHOQOL-BREF Health Satisfaction, minimum score 0, maximum score 5, a higher score represents a better outcome) in the intervention group compared to control group
Effect of the multidomain intervention on sleep quality	Baseline, 6 and 9 months after the start of the intervention	Changes in the Pittsburgh Sleep Quality Index (PSQI, minimum score 0, maximum score 21, a higher score indicates a worse outcome) in the intervention group compared to control group
Effect of the multidomain intervention on the number of hospitalization	6 and 9 months after the start of the intervention	Incidence (number) of hospitalizations during follow-up in the intervention group compared to control group
Effect of the multidomain intervention on the number of falls	6 and 9 months after the start of the intervention	Incidence (number) of falls during follow-up in the intervention group compared to control group

Trial Locations

Locations (2)

RSA Cremona Solidale; 🇮🇹 Cremona, Italy

AltaVita IRA; 🇮🇹 Padova, Italy