Clinical trial NCT06820710: Multidomain Interventions for Elderly Individuals in Residential Structures
Official title: Multidomain Interventions to Improve the COgnitive and fUNctional Well-being of Elderly Individuals in Residential sTructures (I-COUNT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Sponsor class: NETWORK
First posted: 2025-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Effect of the multidomain intervention on the gut microbiota composition
timeFrame: Baseline and 3 months after the start of the intervention
measure: Effect of the multidomain intervention on the gut microbiota composition
timeFrame: Baseline and 3 months after the start of the intervention
measure: Effect of the multidomain intervention on the gut microbiota composition
timeFrame: Baseline and 3 months after the start of the intervention
Secondary outcomes:
measure: Feasibility of the multidomain intervention
timeFrame: At the end of the intervention (6 months after the start)
measure: Effect of the multidomain intervention on the gut microbiota composition
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on the gut microbiota composition
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on the gut microbiota composition
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers of aging
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers of aging
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers of aging
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers of aging
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers of aging
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on specific biomarkers of aging
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on the nutritional status
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on anthropometric status and body composition
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on anthropometric status and body composition
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on anthropometric status and body composition
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on anthropometric status and body composition
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on upper limb strength
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on general and domain-specific cognitive functioning
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on physical performance
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on psychological health
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on psychological health
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on psychological health
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on quality of life
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on quality of life
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on quality of life
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on quality of life
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on quality of life
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on quality of life
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on sleep quality
timeFrame: Baseline, 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on the number of hospitalization
timeFrame: 6 and 9 months after the start of the intervention
measure: Effect of the multidomain intervention on the number of falls
timeFrame: 6 and 9 months after the start of the intervention
Other outcomes:
Locations:
city: Cremona
country: Italy
facility: RSA Cremona Solidale
city: Padova
country: Italy
facility: AltaVita IRA
Study officials:
References: