A Multi-domain Intervention for Healthy Aging (MultiMusic)

University of Bari

Status: Enrolling

Conditions: Healthy Volunteer Study

Treatments: Other: Multidomain Intervention; Other: General activities

Study type: Interventional

Funder types: Other

Identifiers

NCT06767410

ET-23-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 65
• Living independently

Exclusion criteria

• Musical expertise
• Severe cognitive or functional impairment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Multidomain group

Experimental group

Description:

Participants who undergo regularly a series of activities involving different domains (e.g., physical activity, choir, horticulture etc.).

Treatment:

Other: Multidomain Intervention

Active control group

Active Comparator group

Description:

Participants who undergo regularly a series of activities but not musical acivities

Treatment:

Other: General activities

Passive control group

No Intervention group

Description:

Participants who undergo any activity or just sporadic activities