NCT06767410

A Multi-domain Intervention for Healthy Aging

A Multi-domain Intervention to Constrast Cognitive Decline in Healthy Aging

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the long-term impact of a non-pharmacological intervention including several activities (e.g., physical activity, choir, learning programs, horticulture, etc.) to prevent cognitive impairment in community-dwelling elderly individuals with aspects of frailty. The main questions it aims to answer are: * Does engaging in multiple activities, including music, slow the degeneration of perceptual and cognitive functions? * Is it possible to foster beneficial brain changes even during aging? * Can regularly attending social contexts reduce the risk of loneliness and provide fulfillment in later life? Researchers will compare participants involved in the multidomain intervention, including music, to another active group carrying out several activities but without music, and to a passive control group. Participants will: * Participate in the programs for 9 months; * Be tested three times (before and after the intervention, and at a 6-month follow-up); * Keep a weekly diary of the actual time spent in their activities.

Detailed description

Brain-Derived Neurotrophic Factor (BDNF) plays a crucial role in neuroplasticity, supporting brain health throughout life and even during aging. This longitudinal study investigates the impact of a 9-month multidomain intervention, including choral practice, on BDNF levels, as well as audiometric and neuropsychological outcomes, in older adults, who are also assessed for their multidimensional frailty, based on their physical, cognitive, and nutritional conditions. BDNF levels, along with geriatric, neuropsychological, audiometric, and neurophysiological measures, are collected via saliva samples both pre- and post-intervention. For the longitudinal analyses of BDNF, up to 60 elderly individuals will be recruited from several recreational centers located in Southern Italy. Of these, one group will engage in a multidomain program that includes choir, physical, intellectual, and manual activities. The other two control groups will engage either in sporadic non-musical activities or no activity, or in various non-musical activities. Participation in all activities will be monitored via diaries. The researchers' primary goal is to investigate whether engaging in physical, cognitive, and social activities can enhance neuroplasticity, as measured by BDNF levels, to counteract aspects of multidimensional frailty (as assessed by the multidimensional prognostic score, MPI) in the aging population. Secondly, the researchers aim to relate changes in BDNF levels to perceptual and cognitive functions and psychosocial well-being. Although previous studies point out the positive effects of musical training and active aging on brain health, the scarcity of longitudinal research on BDNF effects in older individuals leaves the issue open. Moreover, the researchers aim to test whether non-invasive, accessible saliva-based BDNF measurements, despite some reliability limitations, could offer indications of neuroprotection in aging.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
OTHER	Multidomain Intervention	The intervention is distinguished by its multidomain approach combining cognitive, social, and musical activities through choir participation, targeting holistic cognitive and emotional benefits, unlike active controls (general activities) and passive controls (no activities).
OTHER	General activities	Participants will carry out a series of physical, manual and/or intellectual activities (e.g., horticulture, physical activities, theatre, learning programs etc.) but not musical activities

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

4 sites across 1 country: Italy