AgingI-COUNTNCT06820710
Multidomain Interventions for Elderly Individuals in Residential Structures
A study testing Physical activity, Cognitive stimulation and Nutritional Intervention in people with Aging and Age-Related Cognitive Decline, run by Istituto di Neuroscienze Consiglio Nazionale delle Ricerche at 2 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aging, Age-Related Cognitive Decline, Sarcopenia
- What is being tested?
- Physical activity, Cognitive stimulation and Nutritional Intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesItaly
- Study dates
- 3 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
RSA Cremona Solidale
Cremona, Italy, 26100
AltaVita IRA
Padova, Italy, 35137
About this study
Official title: Multidomain Interventions to Improve the COgnitive and fUNctional Well-being of Elderly Individuals in Residential sTructures (I-COUNT)
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.
Read the 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
- Being tested
- Physical activity, Cognitive stimulation, Nutritional Intervention, Vaccinations
- Keywords
- aging, long term care facilities, multidimensional interventions, cognitive training, physical exercise, nutritional intervention, functional foods, vaccinations
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
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 stimulationOther
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 InterventionOther
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.
VaccinationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multidomain Intervention group | Experimental | 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. Receives: Other: Physical activity; Other: Cognitive stimulation; Other: Nutritional Intervention; Other: Vaccinations |
| Control group (usual activities) | No intervention | Subjects in the control group will receive general information on healthy lifestyles and health, including risk factors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the multidomain intervention on the gut microbiota composition
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
Measured: Baseline and 3 months after the start of the intervention
Effect of the multidomain intervention on the gut microbiota composition
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
Measured: Baseline and 3 months after the start of the intervention
Effect of the multidomain intervention on the gut microbiota composition
Changes in gut microbiota in terms of gene or transcript counts (measured as counts) in the intervention group compared to control group
Measured: Baseline and 3 months after the start of the intervention
Secondary outcomes (38)
Feasibility of the multidomain intervention
Number of drop out (number) in the intervention group compared to control group
Measured: At the end of the intervention (6 months after the start)
Effect of the multidomain intervention on the gut microbiota composition
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the gut microbiota composition
Changes in gut microbiota in terms of gene or transcript counts (measured as counts) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the gut microbiota composition
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in cholesterol (measured in mg/dl) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in triglycerides (measured in mg/dL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in blood glucose (measured in mg/dL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in vitamin D (measured in nmol/L) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in transferrin (measured in mg/dL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in albumin (measured in g/dL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in FT3 (measured in pg/mL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Changes in FT4 (measured in ng/dL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Changes in IL-6 (measured in pg/mL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Changes in BDNF (measured in ng/ml) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Changes in s-RAGE (measured in pg/mL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Changes in irisin (measured in ng/ml) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Changes in IGF1 (measured in ng/mL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Changes in ghrelin (measured in pg/mL) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the nutritional status
Changes in Mini Nutritional Assessment (MNA, score 0-30, a higher score indicates a better outcome) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
Changes in waist circumference (measured in cm) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
Changes in calf circumference (measured in cm) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
Changes in mid-upper arm circumference (measured in cm) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on upper limb strength
Changes in upper limb strength evaluated with electronic hand dynamometers (measured in kg) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on general and domain-specific cognitive functioning
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on physical performance
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on psychological health
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on psychological health
Changes in the Perceived Stress Scale (PSS, minimum score 0, maximum score 40, a higher score indicates worse outcome) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on psychological health
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Changes in the World Health Organization Quality of Life Scale (WHOQOL-BREF Psychological Health, minimum score 0, maximum score 100, a higher score represents a better outcome) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Changes in the World Health Organization Quality of Life Scale (WHOQOL-BREF Social Relationships, minimum score 0, maximum score 100, a higher score represents a better outcome) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Changes in the World Health Organization Quality of Life Scale (WHOQOL-BREF Environment, minimum score 0, maximum score 100, a higher score represents a better outcome) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Changes in the World Health Organization Quality of Life Scale (WHOQOL-BREF Quality of Life, minimum score 0, maximum score 5, a higher score represents a better outcome) in the intervention group compared to control group
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on sleep quality
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
Measured: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the number of hospitalization
Incidence (number) of hospitalizations during follow-up in the intervention group compared to control group
Measured: 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the number of falls
Incidence (number) of falls during follow-up in the intervention group compared to control group
Measured: 6 and 9 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start3 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820710
- Sponsor's protocol ID
- 4-2024-SPERIM_ALTRO-CR4
- Other IDs
- 5982/U6/24
- Acronym
- I-COUNT
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceolin C, Pasolini G, Papa MV, Scotti G, Bobbo A, Macchia E, Ghidini A, Romeo Z, Sergi G, De Rui M, Gentile S, Maggi S, Morandi A, Noale M; I-COUNT study group. Effects of a multidomain intervention on physical performance and sarcopenia in long-term care facility residents: The I-COUNT pilot randomized controlled trial. J Nutr Health Aging. 2026 Aug 13;30(10):100943. doi: 10.1016/j.jnha.2026.100943. Online ahead of print.
PubMed 42594504Romeo 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.
PubMed 40868616
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidomain Interventions to Improve the COgnitive and fUNctional Well-being of Elderly Individuals in Residential sTructures (I-COUNT)
- ClinicalTrials.gov ID
- NCT06820710
- Acronym / sponsor ID
- I-COUNT / 4-2024-SPERIM_ALTRO-CR4
- Conditions
- Aging, Age-Related Cognitive Decline, Sarcopenia, Long Term Care Facility, Cognitive Training, Physical Exercise
- Keywords
- aging, long term care facilities, multidimensional interventions, cognitive training, physical exercise, nutritional intervention, functional foods, vaccinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istituto di Neuroscienze Consiglio Nazionale delle RicercheResearch network
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multidomain Intervention group | Experimental | Other: Physical activity, Other: Cognitive stimulation, Other: Nutritional Intervention, Other: VaccinationsThe 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. |
| Control group (usual activities) | No intervention | –Subjects in the control group will receive general information on healthy lifestyles and health, including risk factors. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAppropriate 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. | Other | Multidomain Intervention group |
| Cognitive stimulationCognitive 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. | Other | Multidomain Intervention group |
| Nutritional InterventionParticipants 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. | Other | Multidomain Intervention group |
| VaccinationsParticipants 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. | Other | Multidomain Intervention group |
Primary outcome
Effect of the multidomain intervention on the gut microbiota composition
Time frame: 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
Effect of the multidomain intervention on the gut microbiota composition
Time frame: Baseline and 3 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 the gut microbiota composition
Time frame: 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
38 secondary outcomes
Feasibility of the multidomain intervention
Time frame: At the end of the intervention (6 months after the start)
Effect of the multidomain intervention on the gut microbiota composition
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the gut microbiota composition
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the gut microbiota composition
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on specific biomarkers of aging
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the nutritional status
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on anthropometric status and body composition
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on upper limb strength
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on general and domain-specific cognitive functioning
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on physical performance
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on psychological health
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on psychological health
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on psychological health
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on quality of life
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on sleep quality
Time frame: Baseline, 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the number of hospitalization
Time frame: 6 and 9 months after the start of the intervention
Effect of the multidomain intervention on the number of falls
Time frame: 6 and 9 months after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 42594504Ceolin C, Pasolini G, Papa MV, Scotti G, Bobbo A, Macchia E, Ghidini A, Romeo Z, Sergi G, De Rui M, Gentile S, Maggi S, Morandi A, Noale M; I-COUNT study group. Effects of a multidomain intervention on physical performance and sarcopenia in long-term care facility residents: The I-COUNT pilot randomized controlled trial. J Nutr Health Aging. 2026 Aug 13;30(10):100943. doi: 10.1016/j.jnha.2026.100943. Online ahead of print.
- Derived from this study: PubMed 40868616Romeo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity, Cognitive stimulation and Nutritional Intervention in people with Aging and Age-Related Cognitive Decline, run by Istituto di Neuroscienze Consiglio Nazionale delle Ricerche at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the multidomain intervention on the gut microbiota composition (time frame: Baseline and 3 months after the start of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06820710, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.