Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-10-01
Study Completion Date
2027-12-31
Brief Summary
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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.
* 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.
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Detailed Description
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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.
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
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Healthy Volunteer Study
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Study Groups
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Multidomain group
Participants who undergo regularly a series of activities involving different domains (e.g., physical activity, choir, horticulture etc.).
Group Type
EXPERIMENTAL
Multidomain Intervention
Intervention Type
OTHER
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).
Active control group
Participants who undergo regularly a series of activities but not musical acivities
Group Type
ACTIVE_COMPARATOR
General activities
Intervention Type
OTHER
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
Passive control group
Participants who undergo any activity or just sporadic activities
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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).
Intervention Type
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
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 65
* Living independently
* Living independently
Exclusion Criteria
* Musical expertise
* Severe cognitive or functional impairment
* Severe cognitive or functional impairment
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Bari
OTHER
Sponsor Role
lead
Responsible Party
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Elvira Brattico
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Musica In Gioco
Adelfia, Bari, Italy
Site Status
RECRUITING
University of Bari
Bari, Bari, Italy
Site Status
RECRUITING
Centro Servizi per la famiglia Libertà
Bari, Bari, Italy
Site Status
RECRUITING
ANAS Puglia (Associazione Nazionale di Azione Sociale)
Bari, Bari, Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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Wang X, Soshi T, Yamashita M, Kakihara M, Tsutsumi T, Iwasaki S, Sekiyama K. Effects of a 10-week musical instrument training on cognitive function in healthy older adults: implications for desirable tests and period of training. Front Aging Neurosci. 2023 Aug 15;15:1180259. doi: 10.3389/fnagi.2023.1180259. eCollection 2023.
Reference Type
BACKGROUND
Vrijen C, Schenk HM, Hartman CA, Oldehinkel AJ. Measuring BDNF in saliva using commercial ELISA: Results from a small pilot study. Psychiatry Res. 2017 Aug;254:340-346. doi: 10.1016/j.psychres.2017.04.034. Epub 2017 Apr 22.
Reference Type
BACKGROUND
Veronese N, Noale M, Cella A, Custodero C, Smith L, Barbagelata M, Maggi S, Barbagallo M, Sabba C, Ferrucci L, Pilotto A. Multidimensional frailty and quality of life: data from the English Longitudinal Study of Ageing. Qual Life Res. 2022 Oct;31(10):2985-2993. doi: 10.1007/s11136-022-03152-9. Epub 2022 May 17.
Reference Type
BACKGROUND
Seinfeld S, Figueroa H, Ortiz-Gil J, Sanchez-Vives MV. Effects of music learning and piano practice on cognitive function, mood and quality of life in older adults. Front Psychol. 2013 Nov 1;4:810. doi: 10.3389/fpsyg.2013.00810. eCollection 2013.
Reference Type
BACKGROUND
Rosenberg A, Ngandu T, Rusanen M, Antikainen R, Backman L, Havulinna S, Hanninen T, Laatikainen T, Lehtisalo J, Levalahti E, Lindstrom J, Paajanen T, Peltonen M, Soininen H, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Solomon A, Kivipelto M. Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial. Alzheimers Dement. 2018 Mar;14(3):263-270. doi: 10.1016/j.jalz.2017.09.006. Epub 2017 Oct 19.
Reference Type
BACKGROUND
Perus L, Busto GU, Mangin JF, Le Bars E, Gabelle A. Effects of preventive interventions on neuroimaging biomarkers in subjects at-risk to develop Alzheimer's disease: A systematic review. Front Aging Neurosci. 2022 Nov 24;14:1014559. doi: 10.3389/fnagi.2022.1014559. eCollection 2022.
Reference Type
BACKGROUND
Pentikainen E, Kimppa L, Pitkaniemi A, Lahti O, Sarkamo T. Longitudinal effects of choir singing on aging cognition and wellbeing: a two-year follow-up study. Front Hum Neurosci. 2023 Jul 20;17:1174574. doi: 10.3389/fnhum.2023.1174574. eCollection 2023.
Reference Type
BACKGROUND
Nazam F, Shaikh S, Nazam N, Alshahrani AS, Hasan GM, Hassan MI. Mechanistic insights into the pathogenesis of neurodegenerative diseases: towards the development of effective therapy. Mol Cell Biochem. 2021 Jul;476(7):2739-2752. doi: 10.1007/s11010-021-04120-6. Epub 2021 Mar 9.
Reference Type
BACKGROUND
Nettiksimmons J, Simonsick EM, Harris T, Satterfield S, Rosano C, Yaffe K; Health ABC Study. The associations between serum brain-derived neurotrophic factor, potential confounders, and cognitive decline: a longitudinal study. PLoS One. 2014 Mar 26;9(3):e91339. doi: 10.1371/journal.pone.0091339. eCollection 2014.
Reference Type
BACKGROUND
Moon SY, Kim S, Choi SH, Hong CH, Park YK, Na HR, Song HS, Park HK, Choi M, Lee SM, Chun BO, Lee JM, Jeong JH. Impact of Multidomain Lifestyle Intervention on Cerebral Cortical Thickness and Serum Brain-Derived Neurotrophic Factor: the SUPERBRAIN Exploratory Sub-study. Neurotherapeutics. 2022 Sep;19(5):1514-1525. doi: 10.1007/s13311-022-01276-x. Epub 2022 Aug 1.
Reference Type
BACKGROUND
Mizoguchi Y, Yao H, Imamura Y, Hashimoto M, Monji A. Lower brain-derived neurotrophic factor levels are associated with age-related memory impairment in community-dwelling older adults: the Sefuri study. Sci Rep. 2020 Oct 5;10(1):16442. doi: 10.1038/s41598-020-73576-1.
Reference Type
BACKGROUND
Marie D, Muller CAH, Altenmuller E, Van De Ville D, Junemann K, Scholz DS, Kruger THC, Worschech F, Kliegel M, Sinke C, James CE. Music interventions in 132 healthy older adults enhance cerebellar grey matter and auditory working memory, despite general brain atrophy. Neuroimage Rep. 2023 Mar 23;3(2):100166. doi: 10.1016/j.ynirp.2023.100166. eCollection 2023 Jun.
Reference Type
BACKGROUND
MacAulay, R. K., Edelman, P., Boeve, A., Sprangers, N., & Halpin, A. (2019). Group music training as a multimodal cognitive intervention for older adults. Psychomusicology: Music, Mind, and Brain, 29(4), 180.
Reference Type
BACKGROUND
Lin FR, Ferrucci L, Metter EJ, An Y, Zonderman AB, Resnick SM. Hearing loss and cognition in the Baltimore Longitudinal Study of Aging. Neuropsychology. 2011 Nov;25(6):763-70. doi: 10.1037/a0024238.
Reference Type
BACKGROUND
Lee S, Harada K, Bae S, Harada K, Makino K, Anan Y, Suzuki T, Shimada H. A non-pharmacological multidomain intervention of dual-task exercise and social activity affects the cognitive function in community-dwelling older adults with mild to moderate cognitive decline: A randomized controlled trial. Front Aging Neurosci. 2023 Mar 13;15:1005410. doi: 10.3389/fnagi.2023.1005410. eCollection 2023.
Reference Type
BACKGROUND
Johnson JK, Louhivuori J, Stewart AL, Tolvanen A, Ross L, Era P. Quality of life (QOL) of older adult community choral singers in Finland. Int Psychogeriatr. 2013 Jul;25(7):1055-64. doi: 10.1017/S1041610213000422. Epub 2013 Apr 11.
Reference Type
BACKGROUND
Jabusch HC, Alpers H, Kopiez R, Vauth H, Altenmuller E. The influence of practice on the development of motor skills in pianists: a longitudinal study in a selected motor task. Hum Mov Sci. 2009 Feb;28(1):74-84. doi: 10.1016/j.humov.2008.08.001. Epub 2008 Oct 8.
Reference Type
BACKGROUND
Huang TY, Chou MY, Liang CK, Lin YT, Chen RY, Wu PF. Physical activity plays a crucial role in multidomain intervention for frailty prevention. Aging Clin Exp Res. 2023 Jun;35(6):1283-1292. doi: 10.1007/s40520-023-02412-z. Epub 2023 Apr 26.
Reference Type
BACKGROUND
Hariri AR, Goldberg TE, Mattay VS, Kolachana BS, Callicott JH, Egan MF, Weinberger DR. Brain-derived neurotrophic factor val66met polymorphism affects human memory-related hippocampal activity and predicts memory performance. J Neurosci. 2003 Jul 30;23(17):6690-4. doi: 10.1523/JNEUROSCI.23-17-06690.2003.
Reference Type
BACKGROUND
Ellis RJ, Bruijn B, Norton AC, Winner E, Schlaug G. Training-mediated leftward asymmetries during music processing: a cross-sectional and longitudinal fMRI analysis. Neuroimage. 2013 Jul 15;75:97-107. doi: 10.1016/j.neuroimage.2013.02.045. Epub 2013 Mar 5.
Reference Type
BACKGROUND
Egan MF, Kojima M, Callicott JH, Goldberg TE, Kolachana BS, Bertolino A, Zaitsev E, Gold B, Goldman D, Dean M, Lu B, Weinberger DR. The BDNF val66met polymorphism affects activity-dependent secretion of BDNF and human memory and hippocampal function. Cell. 2003 Jan 24;112(2):257-69. doi: 10.1016/s0092-8674(03)00035-7.
Reference Type
BACKGROUND
Dubinsky E, Wood EA, Nespoli G, Russo FA. Short-Term Choir Singing Supports Speech-in-Noise Perception and Neural Pitch Strength in Older Adults With Age-Related Hearing Loss. Front Neurosci. 2019 Nov 28;13:1153. doi: 10.3389/fnins.2019.01153. eCollection 2019.
Reference Type
BACKGROUND
Driscoll I, Martin B, An Y, Maudsley S, Ferrucci L, Mattson MP, Resnick SM. Plasma BDNF is associated with age-related white matter atrophy but not with cognitive function in older, non-demented adults. PLoS One. 2012;7(4):e35217. doi: 10.1371/journal.pone.0035217. Epub 2012 Apr 16.
Reference Type
BACKGROUND
Draganski B, Gaser C, Busch V, Schuierer G, Bogdahn U, May A. Neuroplasticity: changes in grey matter induced by training. Nature. 2004 Jan 22;427(6972):311-2. doi: 10.1038/427311a. No abstract available.
Reference Type
BACKGROUND
Dichter BK, Breshears JD, Leonard MK, Chang EF. The Control of Vocal Pitch in Human Laryngeal Motor Cortex. Cell. 2018 Jun 28;174(1):21-31.e9. doi: 10.1016/j.cell.2018.05.016.
Reference Type
BACKGROUND
Chikahisa S, Sei H, Morishima M, Sano A, Kitaoka K, Nakaya Y, Morita Y. Exposure to music in the perinatal period enhances learning performance and alters BDNF/TrkB signaling in mice as adults. Behav Brain Res. 2006 May 15;169(2):312-9. doi: 10.1016/j.bbr.2006.01.021. Epub 2006 Mar 10.
Reference Type
BACKGROUND
Chaddock-Heyman L, Loui P, Weng TB, Weisshappel R, McAuley E, Kramer AF. Musical Training and Brain Volume in Older Adults. Brain Sci. 2021 Jan 5;11(1):50. doi: 10.3390/brainsci11010050.
Reference Type
BACKGROUND
Bugos JA, Perlstein WM, McCrae CS, Brophy TS, Bedenbaugh PH. Individualized piano instruction enhances executive functioning and working memory in older adults. Aging Ment Health. 2007 Jul;11(4):464-71. doi: 10.1080/13607860601086504.
Reference Type
BACKGROUND
Bugos JA, Bidelman GM, Moreno S, Shen D, Lu J, Alain C. Music and Visual Art Training Increase Auditory-Evoked Theta Oscillations in Older Adults. Brain Sci. 2022 Sep 27;12(10):1300. doi: 10.3390/brainsci12101300.
Reference Type
BACKGROUND
Bonetti L, Bruzzone SEP, Paunio T, Kantojarvi K, Kliuchko M, Vuust P, Palva S, Brattico E. Moderate associations between BDNF Val66Met gene polymorphism, musical expertise, and mismatch negativity. Heliyon. 2023 Apr 18;9(5):e15600. doi: 10.1016/j.heliyon.2023.e15600. eCollection 2023 May.
Reference Type
BACKGROUND
Alain C, Moussard A, Singer J, Lee Y, Bidelman GM, Moreno S. Music and Visual Art Training Modulate Brain Activity in Older Adults. Front Neurosci. 2019 Mar 8;13:182. doi: 10.3389/fnins.2019.00182. eCollection 2019.
Reference Type
BACKGROUND
Other Identifiers
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ET-23-27
Identifier Type: -
Identifier Source: org_study_id
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