Clinical trial NCT06767410: A Multi-domain Intervention for Healthy Aging
Official title: A Multi-domain Intervention to Constrast Cognitive Decline in Healthy Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteer Study
Keywords: BDNF
aging
multidomain intervention
music training
neuroplasticity
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65
* Living independently

Exclusion Criteria:

* Musical expertise
* Severe cognitive or functional impairment

Primary outcomes:
measure: Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Cognitive functioning
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Fluid Intelligence
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Hearing Threshold
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Intelligibility
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Speech in noise ability
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Auditory brainstem responses (ABR)
timeFrame: Baseline, 9 months and 6 months follow-up
measure: P300 auditory cortical potentials
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Multidimensional Frailty
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Socio-psychological well being
timeFrame: Baseline, 9 months and 6 months follow-up
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Cognitive Reserve
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Melody Discrimination
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Mistuning Perception
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Emotion Discrimination
timeFrame: Baseline, 9 months and 6 months follow-up
measure: Rhythmic Ability
timeFrame: Baseline, 9 months and 6 months follow-up
Other outcomes:
Locations:
city: Adelfia
country: Italy
facility: Musica In Gioco
state: Bari
city: Bari
country: Italy
facility: University of Bari
city: Bari
country: Italy
facility: Centro Servizi per la famiglia Libertà
city: Bari
country: Italy
facility: ANAS Puglia (Associazione Nazionale di Azione Sociale)
Study officials:
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