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

: Background/Objectives: Multidisciplinary approaches spanning the physical, cognitive, and social domains of geriatric evaluation are essential to promote functional well-being and reduce the aversive consequences of aging. The main objective of the pilot study, "Multidomain Interventions to improve the COgnitive and fUNctional well-being of elderly individuals in residential sTructures" (I-COUNT), is to assess the feasibility of a 6-month multidomain intervention performed on older adults in Long-Term Care Facilities (LTCFs), compared with a group of residents following a traditional care approach. Methods: The intervention will involve two LTCFs in Italy and will include physical exercise and cognitive training, administered and monitored using wearable technologies, a nutritional program based on the Mediterranean diet enriched with selected functional foods, and the administration of the vaccinations recommended in the national vaccination plan. The I-COUNT study will assess the feasibility and acceptability of the defined protocol and provide information to determine the sample size for a definitive study. In relation to the potential health impact of multidomain interventions on older people living in LTCFs, the primary outcome will consider the change in microbiota composition assessed 3 months after the start of interventions, while secondary outcomes will include the evaluation of changes in selected biomarkers, physical performance, psychological health, cognitive functioning, and nutritional status at 6- and 9-month follow-up points. Conclusions: The I-COUNT study will allow us to assess the feasibility of delivering a multidomain intervention on elderly people. Exploratory findings on potential health effect will support the development of a larger-scale randomized controlled trial. Trial registration number: ClinicalTrials.gov ID NCT06820710.