Age-Related Cognitive Decline, Aging, Cognitive Training, Functional Food, Long Term Care Facility, Nutritional Intervention, Physical Exercise, Sarcopenia, Vaccinations
Conditions
Keywords
aging, long term care facilities, multidimensional interventions, cognitive training, physical exercise, nutritional intervention, functional foods, vaccinations
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).
Interventions
OTHERPhysical 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.
OTHERCognitive 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.
OTHERNutritional 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.
OTHERVaccinations
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.
Sponsors
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the multidomain intervention on the gut microbiota composition | Baseline and 3 months after the start of the intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 biodiversity measured as species richness (number of different taxa identified in each sample) 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 cholesterol (measured in mg/dl) in the intervention group compared to control group |
| Effect of the multidomain intervention on specific biomarkers of aging | Baseline, 6 and 9 months after the start of the intervention | Changes in IL-6 (measured in pg/mL) 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 body mass index (BMI, with weight measured in kg and height measured in m combined to report BMI in kg/m\^2) 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 Geriatric Depression Scale (GDS, minimum score 0, maximum score 30, a higher score indicates a 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 Physical Health, minimum score 0, maximum score 100, 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 |
Countries
Italy
Outcome results
None listed