Actively Recruiting
Led by University of Milano Bicocca · Updated on 2025-07-29
1340
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of Milano Bicocca
Lead Sponsor
E
European Union
Collaborating Sponsor
Researchers are investigating whether a tailored multi-domain intervention can help prevent functional and cognitive decline in older adults considered at risk. This interventional study focuses on community-dwelling adults aged 60 and older who show mild to moderate vulnerability and increased risk of developing dementia based on various health and lifestyle factors. The interventions aim to address multiple areas including physical health, nutrition, cognition, and social well-being to support healthy aging. Participants in the active intervention group will receive a combination of physical exercise, a Mediterranean diet plan, cognitive training, regular medical check-ups, oral hygiene counseling, sleep hygiene support, management of cardiovascular and metabolic risk factors, medication adjustments, and encouragement of social interactions. These activities will be supported and monitored through wearable devices, digital tools, and apps. The control group will receive standard health advice through apps and a one-time counseling session, reflecting usual clinical care. The study includes an initial screening visit involving detailed assessments of cognitive function, physical performance, frailty, and dementia risk factors. Eligible participants will then be followed for 18 months, with baseline and three follow-up visits at 6, 12, and 18 months to collect data on various cognitive, physical, psychological, and quality of life measures. Researchers will monitor outcomes such as neuropsychological test scores, physical performance, daily living activities, mood, sleep quality, nutrition, and incidence of mild cognitive impairment or dementia. The total participation period spans approximately two years including observation of health events like falls and hospital visits.
CONDITIONS
ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial through a multi-faceted evaluation of cognitive function, physical and functional efficiency, and cardiovascular and cognitive decline risk factors.
1 visit (in-person)
Duration - 18 months
Eligible participants receive tailored multidomain interventions including physical exercise, Mediterranean diet-based nutrition, cognitive training, oral hygiene counseling, sleep quality assessment and advice, control of cardiovascular and metabolic risk factors, pharmacological evaluation, and social activity encouragement. Participants in the active intervention arm attend group and individual sessions and use digital tools and wearable devices. Those in the self-administered intervention arm receive counseling and health advice via dedicated apps and portals.
1 baseline visit and 3 follow-up visits at 6, 12, and 18 months
Total: 1 location
1
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Actively Recruiting
C
Carlo Ferrarese
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Gessica Sala, Luca Cuffaro, Federico Emanuele Pozzi...
https://pubmed.ncbi.nlm.nih.gov/40400914