A Multi-domain Intervention for Healthy Aging

NCT06767410 | Recruiting

• 1 other identifier: ET-23-27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy Volunteer Study

Keywords

BDNF; aging; multidomain intervention; music training; neuroplasticity

Outcome Measures

Primary Outcomes (10)

• Brain-Derived Neurotrophic Factor (BDNF)

  BDNF levels detected in saliva

  Baseline, 9 months and 6 months follow-up

• Cognitive functioning

  Assessed using the Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005), a widely used screening tool for cognitive impairment that evaluates multiple cognitive domains, including attention, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Description of the task: The MoCA consists of 30 items, covering various cognitive tasks such as word recall, trail-making, and visuospatial exercises. Unit of Measure: Raw score, ranging from 0 to 30, where higher scores indicate better cognitive functioning. A score below 26 typically indicates mild cognitive impairment. Interpretation: Higher scores reflect better cognitive performance. The measure is commonly used to detect cognitive deficits and track cognitive changes over time.

  Baseline, 9 months and 6 months follow-up

• Fluid Intelligence

  Assessed with computerized Matrix Reasoning (Condon \& Revelle 2014; Chan \& Kosinski, 2015), a test that contains stimuli that are similar to those used in Raven's Progressive Matrices. Task Description: The stimuli are 3 × 3 arrays of geometric shapes with one of the nine shapes missing. Participants are instructed to identify which of the six geometric shapes presented as response choices will best complete the stimuli. In each round the stimulus disappears after 120 s, leaving only the response options visible for the participant. Unit of Measure: The score is calculated as a standardized z-score, with a mean of 0 and no fixed minimum or maximum value. Scores can be both positive or negative, depending on the participant's performance relative to the sample distribution. Interpretation: Higher positive scores indicate better-than-average performance in reasoning ability, while negative scores indicate below-average performance. This measure is suitable for evaluating individual

  Baseline, 9 months and 6 months follow-up

• Hearing Threshold

  Assessed using a liminal tonal audiometric test, which determines the participant's minimum acoustic intensity perceivable at different tonal field frequencies. Description of the task: Participants are tested across a range of frequencies in a soundproof booth to identify the lowest intensity level at which they can detect a tone. Unit of Measure: Hearing threshold in decibels hearing level (dB HL), measured for each frequency. Lower thresholds (i.e., lower dB HL values) indicate better hearing sensitivity. Interpretation: Lower dB HL values indicate better hearing ability. The results are used to identify any hearing loss and its severity at specific frequencies.

  Baseline, 9 months and 6 months follow-up

• Intelligibility

  Assessed using speech audiometry, which evaluates the participant's ability to recognize and understand spoken words in a controlled environment. Description of the task: Participants are presented with vocal material (e.g., phonemes, logotomes, words, sentences) in a silent booth and must repeat what they hear. Unit of Measure: Percentage of correctly recognized words, where higher percentages indicate better speech intelligibility. Interpretation: Higher percentages indicate better verbal recognition and understanding. This measure helps assess speech comprehension in quiet conditions.

  Baseline, 9 months and 6 months follow-up

• Speech in noise ability

  Assessed using a Matrix Sentence Test, which evaluates speech comprehension under noisy conditions. Description of the task: Participants are presented with 5-word sentences along with a background noise (competition noise) and must repeat the sentences. The test adapts after each response by adjusting the difficulty (increasing or decreasing the noise level) until the participant reaches a 50% comprehension threshold. Unit of Measure: Signal Reception Threshold (SRT) in decibels (dB). The SRT represents the difference between the word volume and the noise volume at which the participant understands 50% of the words. Interpretation: Lower SRT values indicate better speech comprehension under noisy conditions.

  Baseline, 9 months and 6 months follow-up

• Auditory brainstem responses (ABR)

  Measure of the neural activity along the auditory pathway in response to a brief acoustic stimulus. Description of the task: Short-duration acoustic stimuli (100 μs clicks) are presented independently to each ear at 90 dBnHL, with filters set at 100 and 3000 Hz. The resulting waveforms represent the activity of the auditory nerve and brainstem. Unit of Measure: Latencies of waves I-V in milliseconds (ms). Longer latencies may indicate abnormalities in the auditory pathway. Interpretation: Normal latencies indicate typical auditory nerve and brainstem function. Abnormal latencies may suggest issues such as hearing loss or neural conduction delays.

  Baseline, 9 months and 6 months follow-up

• P300 auditory cortical potentials

  Measures higher-level auditory processing and cognitive responses to auditory stimuli. Description of the task: Tones (50 ms) are presented at a rate of 1.1/s, with standard stimuli occurring 80% of the time and target stimuli randomly occurring 20% of the time. Participants are required to detect and respond to the target stimuli. The P300 response is recorded using electrodes in the same montage as for the ABR. Unit of Measure: P300 latency in milliseconds (ms) and P300 amplitude in microvolts (µV). Shorter latencies and higher amplitudes indicate better cognitive and auditory processing. Interpretation: Shorter P300 latencies and higher amplitudes suggest more efficient auditory and cognitive processing. Prolonged latencies or reduced amplitudes may indicate deficits in auditory or cognitive functions.

  Baseline, 9 months and 6 months follow-up

• Multidimensional Frailty

  Assessed using the Selfy-MPI (Pilotto et al., 2019), a self-administered digital tool via the Portable-MPI app. Description: The Selfy-MPI evaluates frailty across several dimensions, including: Functional status and independence: Measured by ADLs and IADLs. Mobility: Assessed through self-reported ability to move independently. Cognitive condition: Evaluated with a brief cognitive test. Nutritional status: Measured using the Mini Nutritional Assessment (MNA). Comorbidity: Assessed using the Cumulative Illness Rating Scale (CIRS). Medication use: Evaluated via the ATC classification for polypharmacy. Living situation: Assessed by questions on living arrangements. Unit of Measure: Composite score ranging from 0 to 1, where: 0-0.33: Low frailty risk 0.34-0.66: Moderate frailty risk 0.67-1.00: Severe frailty risk Interpretation: Higher scores indicate greater frailty.

  Baseline, 9 months and 6 months follow-up

• Socio-psychological well being

  Assessed using the Flourishing Scale (Diener et al., 2010), a self-report measure that evaluates various domains, including relationships, purpose in life, and self-esteem. Description of the task: Participants rate 8 statements related to different aspects of their well-being (e.g., "I lead a purposeful and meaningful life") on a scale from 1 (Strongly disagree) to 7 (Strongly agree). Unit of Measure: The total score ranges from 8 to 56, with higher scores indicating greater psychological flourishing and well-being. Interpretation: Higher scores reflect better overall well-being, life satisfaction, and psychological functioning.

  Baseline, 9 months and 6 months follow-up

Secondary Outcomes (6)

• Physical activity

  Baseline, 9 months and 6 months follow-up

• Cognitive Reserve

  Baseline, 9 months and 6 months follow-up

• Melody Discrimination

  Baseline, 9 months and 6 months follow-up

• Mistuning Perception

  Baseline, 9 months and 6 months follow-up

• Emotion Discrimination

  Baseline, 9 months and 6 months follow-up

Study Arms (3)

Multidomain group

EXPERIMENTAL

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

Other: Multidomain Intervention

Active control group

ACTIVE COMPARATOR

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

Other: General activities

Passive control group

NO INTERVENTION

Participants who undergo any activity or just sporadic activities

Interventions

Multidomain Intervention 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).

Multidomain group

General activities 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

Active control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65
• Living independently

You may not qualify if:

• Musical expertise
• Severe cognitive or functional impairment

Sponsors & Collaborators

• University of Bari: lead

Study Sites (4)

Musica In Gioco

Adelfia, Bari, 70010, Italy

RECRUITING

University of Bari

Bari, Bari, 70121, Italy

RECRUITING

Centro Servizi per la famiglia Libertà

Bari, Bari, 70122, Italy

RECRUITING

ANAS Puglia (Associazione Nazionale di Azione Sociale)

Bari, Bari, 70125, Italy

RECRUITING

Related Publications (31)

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• 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.

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• 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.

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  BACKGROUND

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Central Study Contacts

Elvira Brattico, Professor

CONTACT

+390805714702; elvira.brattico@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (4)