A Multi-domain Intervention for Healthy Aging

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Brain-Derived Neurotrophic Factor (BDNF) [Time frame: Baseline, 9 months and 6 months follow-up]
• Cognitive functioning [Time frame: Baseline, 9 months and 6 months follow-up]
• Fluid Intelligence [Time frame: Baseline, 9 months and 6 months follow-up]
• Hearing Threshold [Time frame: Baseline, 9 months and 6 months follow-up]
• Intelligibility [Time frame: Baseline, 9 months and 6 months follow-up]
• Speech in noise ability [Time frame: Baseline, 9 months and 6 months follow-up]
• Auditory brainstem responses (ABR) [Time frame: Baseline, 9 months and 6 months follow-up]
• P300 auditory cortical potentials [Time frame: Baseline, 9 months and 6 months follow-up]
• Multidimensional Frailty [Time frame: Baseline, 9 months and 6 months follow-up]
• Socio-psychological well being [Time frame: Baseline, 9 months and 6 months follow-up]

Secondary outcome measures (6)

• Physical activity [Time frame: Baseline, 9 months and 6 months follow-up]
• Cognitive Reserve [Time frame: Baseline, 9 months and 6 months follow-up]
• Melody Discrimination [Time frame: Baseline, 9 months and 6 months follow-up]
• Mistuning Perception [Time frame: Baseline, 9 months and 6 months follow-up]
• Emotion Discrimination [Time frame: Baseline, 9 months and 6 months follow-up]
• Rhythmic Ability [Time frame: Baseline, 9 months and 6 months follow-up]

Eligibility criteria

Inclusion criteria

• Age ≥ 65
• Living independently

Exclusion criteria

• Musical expertise
• Severe cognitive or functional impairment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Italy · 4 centers

• Musica In Gioco — Adelfia
• University of Bari — Bari
• Centro Servizi per la famiglia Libertà — Bari
• ANAS Puglia (Associazione Nazionale di Azione Sociale) — Bari

Publications

• 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. PMID 37649718
• 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. PMID 28525789
• 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. PMID 35579730
• 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. PMID 24198804
• 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: PMID 29055814
• 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. PMID 36506466
• 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. PMID 37545597
• 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. PMID 33687588

Identifiers

NCT: NCT06767410 · ET-23-27

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗