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Completed

NCT Number: NCT06820710

Multidomain Interventions for Elderly Individuals in Residential Structures

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSA Cremona Solidale, Cremona, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Other

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 stimulation

Other

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 intervention

Other

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.

Vaccinations

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Feasibility of the multidomain intervention

    Time frame: At the end of the intervention (6 months after the start)

    Number of drop out (number) in the intervention group compared to control group

  2. Effect of the multidomain intervention on the gut microbiota composition

    Time frame: 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

  3. Effect of the multidomain intervention on the gut microbiota composition

    Time frame: Baseline, 6 and 9 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

  4. Effect of the multidomain intervention on the gut microbiota composition

    Time frame: 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

  5. Effect of the multidomain intervention on specific biomarkers

    Time frame: 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

  6. Effect of the multidomain intervention on specific biomarkers

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in triglycerides (measured in mg/dL) in the intervention group compared to control group

  7. Effect of the multidomain intervention on specific biomarkers

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in blood glucose (measured in mg/dL) in the intervention group compared to control group

  8. Effect of the multidomain intervention on specific biomarkers

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in vitamin D (measured in nmol/L) in the intervention group compared to control group

  9. Effect of the multidomain intervention on specific biomarkers

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in transferrin (measured in mg/dL) in the intervention group compared to control group

  10. Effect of the multidomain intervention on specific biomarkers

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in albumin (measured in g/dL) in the intervention group compared to control group

  11. Effect of the multidomain intervention on specific biomarkers

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in FT3 (measured in pg/mL) in the intervention group compared to control group

  12. Effect of the multidomain intervention on specific biomarkers

    Time frame: 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

  13. Effect of the multidomain intervention on specific biomarkers of aging

    Time frame: 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

  14. Effect of the multidomain intervention on specific biomarkers of aging

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in BDNF (measured in ng/ml) in the intervention group compared to control group

  15. Effect of the multidomain intervention on specific biomarkers of aging

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in s-RAGE (measured in pg/mL) in the intervention group compared to control group

  16. Effect of the multidomain intervention on specific biomarkers of aging

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in irisin (measured in ng/ml) in the intervention group compared to control group

  17. Effect of the multidomain intervention on specific biomarkers of aging

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in IGF1 (measured in ng/mL) in the intervention group compared to control group

  18. Effect of the multidomain intervention on specific biomarkers of aging

    Time frame: 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

  19. Effect of the multidomain intervention on the nutritional status

    Time frame: 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

  20. Effect of the multidomain intervention on anthropometric status and body composition

    Time frame: 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

  21. Effect of the multidomain intervention on anthropometric status and body composition

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in waist circumference (measured in cm) in the intervention group compared to control group

  22. Effect of the multidomain intervention on anthropometric status and body composition

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    Changes in calf circumference (measured in cm) in the intervention group compared to control group

  23. Effect of the multidomain intervention on anthropometric status and body composition

    Time frame: 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

  24. Effect of the multidomain intervention on upper limb strength

    Time frame: 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

  25. 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

    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

  26. Effect of the multidomain intervention on physical performance

    Time frame: 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

  27. Effect of the multidomain intervention on psychological health

    Time frame: 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

  28. Effect of the multidomain intervention on psychological health

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    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

  29. Effect of the multidomain intervention on psychological health

    Time frame: 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

  30. Effect of the multidomain intervention on quality of life

    Time frame: 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

  31. Effect of the multidomain intervention on quality of life

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    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

  32. Effect of the multidomain intervention on quality of life

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    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

  33. Effect of the multidomain intervention on quality of life

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    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

  34. Effect of the multidomain intervention on quality of life

    Time frame: Baseline, 6 and 9 months after the start of the intervention

    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

  35. Effect of the multidomain intervention on quality of life

    Time frame: 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

  36. Effect of the multidomain intervention on sleep quality

    Time frame: 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

  37. Effect of the multidomain intervention on the number of hospitalization

    Time frame: 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

  38. Effect of the multidomain intervention on the number of falls

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

Network

Registry information

Official study title

Multidomain Interventions to Improve the COgnitive and fUNctional Well-being of Elderly Individuals in Residential sTructures (I-COUNT)

Acronym: I-COUNT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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