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Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp

Primary Purpose

Mild Cognitive Impairment, Age-related Cognitive Decline

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Music Training I

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

aged 60 years or older
willingness to provide informed consent
willingness to complete up to 23 study visits including attending in-lab intervention two times a week for a three-month period with the goal of completing 20 sessions.
ability to speak and understand English
Montreal Cognitive Assessment score of 20 or higher (score 20 to 30 inclusive)
intact vision (binocular near visual acuity of 20/50 or better tested with a standard near visual acuity chart)
adequate hearing acuity (no greater than a moderate hearing loss [thresholds <70 dB HL] in the mid-frequency range [1000, 2000 Hz] in at least one ear as determined by a standard pure tone hearing evaluation)
Music Reading Assessment score of 18 or lower (score 0-18 inclusive)
ability to understand study procedures and comply with them for the length of the study in the tester's opinion (and other study personnel opinion who interact with participant, such as the study physician)

Exclusion Criteria:

moderate or worse depressive symptoms (Geriatric Depression Scale short form score >=5)
previous participation in University of South Florida (USF) Cognitive Aging Lab intervention studies
previous participation in 10 or more hours of a computerized cognitive intervention computer programs (e.g., Lumosity, Posit Science Brain Fitness, InSight, or BrainHQ; Lace, CogMed, CogniFit, Happy Neuron, Dakim, DriveSharp or Staying Sharp programs)
currently enrolled in another research study
planning on being away for two or more weeks during the next five months (recruit later)
undergoing chemotherapy or radiation treatment or planning surgeries or other procedures requiring anesthesia within the next five months (recruit later)
four or more years of formal music training such as private lessons or group lessons on a specific instrument
ability to read music on two or more of the following clefs: Treble clef, Bass clef, Alto clef
four or more years of playing any one musical instrument
currently practicing or participating in any music activities- such as music performance or music reading or music lessons
difficulty and pain in moving hands or fingers, or neuropathy affecting hands, or tremor in either hand
self-reported diagnosis of dementia, stroke, serious brain injury or neurological disorder
diagnosed by a physician or nurse with a TIA that occurred within the last 18 months
inability or unwillingness to give written informed consent at baseline
Clinical Dementia Rating Scale score of 1 or greater
Clinical diagnosis of dementia or other disorder that in the study physician's opinion would limit the persons ability to participate in the study or benefit from the interventions

Sites / Locations

University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Training I

Music Training II

Arm Description

Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument.

Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument

Outcomes

Primary Outcome Measures

Cognition

A composite of performance on Verbal fluency words generated, Trail Making Test time, and Digit Symbol Coding number correct derived from principal components analyses

Secondary Outcome Measures

Central Auditory Processing

A composite will be formed from principal components analyses of number correct for performance on Time Compressed Speech Test (TCS), Words-in-Noise Test (WIN), Dichotic Digits Test (DDT), Dichotic Sentence Identification (DSI) and the threshold in ms of performance on the Adaptive Tests of Temporal Resolution (ATTR).

Everyday Function

A composite will be formed from the time and accuracy of performance on the Timed IADL Test and The Test of Everyday Attention (TEA)

Full Information

NCT ID

NCT03528486

First Posted

March 13, 2018

Last Updated

July 11, 2022

Sponsor

University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT03528486

Brief Title

Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp

Official Title

Interventions to Attenuate Cognitive Decline

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

January 29, 2018 (Actual)

Primary Completion Date

August 30, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Different cognitive intervention approaches have been developed to attenuate decline (e.g., cognitive engagement, training, or stimulation), but it is not clear which approaches are efficacious. It is also not clear when, along the continuum of normal cognitive aging to mild cognitive impairment (MCI-a transitional stage before dementia onset), it is most efficacious to intervene. This randomized clinical trial will determine the efficacy of a novel cognitive engagement intervention approach (music training) as compared to cognitive stimulation (which will serve as a stringent, active control). Grounded in theory, the central hypothesis is that interventions enhancing central auditory processing (CAP), a strong, longitudinal predictor of MCI and dementia, will improve cognition. Music training is increasingly recognized as a feasible means to attenuate age-related cognitive decline. Prior research and preliminary data suggest that intense piano training enhances CAP and is likely more effective than cognitive stimulation. Correlational studies indicate superior CAP, executive function, and other cognitive abilities for adults with formal music training compared to non-musicians. The specific aims of the study are to examine the efficacy of music training relative to cognitive stimulation (active controls) to improve CAP, cognition, and everyday function among older adults with and without MCI. The efficacy of music training will be established and moderating effects of MCI status will be examined. The proposed study further aims to elucidate the underlying mechanisms of effective cognitive intervention approaches by exploring mediators of training gains. The proposed study is the first phase II randomized trial of music training to enhance older adults' cognition. Mediation analyses will elucidate the underlying mechanisms of intervention effects.

Detailed Description

Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp. The primary objectives is to examine the efficacy of music training to improve central auditory processing (CAP), cognition, and everyday function among older adults. The secondary objectives are: To examine the moderating effects of mild cognitive impairment (MCI) on music training efficacy. To explore mediators of intervention effects. Design The design is a two arm randomized clinical trial examining the efficacy of music training to improve CAP, cognition, and everyday function in older adults with and without MCI across two time points (baseline and immediate post-test). Outcomes The effects of of music training on CAP, cognition, and everyday functional performance will be quantified. CAP processing measures will include: Time Compressed Speech 65%, Words-in-Noise, Dichotic Digits Test, Dichotic Sentence Identification, and Adaptive Tests of Temporal Resolution. A composite will be derived from principal components analyses. Cognition measures will include: Verbal Fluency Test (phonemic fluency, category fluency, and category switching), Trail Making Test, and Digit Coding. A composite will be derived from principal component analyses. Everyday Function measures will include: Timed Instrumental Activities of Daily Living and Test of Everyday Attention. A composite will be derived from principal component analyses. Interventions and Duration Two types of music training will be investigated. The two training conditions will be equivalent in terms of frequency and duration of each session (90 min/day, two days/wk, 10 weeks) and social contact (led by trainer and conducted in groups of up to 10 persons). Sample Size and Population In-person screening of a maximum of 500 potential study participants are planned to enroll up to 400 participants. The goal is to have at least 200 participants complete the study. Individuals with normal cognition and those with a clinical diagnosis of MCI will be included in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Age-related Cognitive Decline

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

268 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Music Training I

Arm Type

Experimental

Arm Description

Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument.

Arm Title

Music Training II

Arm Type

Active Comparator

Arm Description

Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument

Intervention Type

Behavioral

Intervention Name(s)

Music Training I

Intervention Description

Participants will be attending group classes, guided by a trainer, with up to 10 other older adults.

Primary Outcome Measure Information:

Title

Cognition

Description

A composite of performance on Verbal fluency words generated, Trail Making Test time, and Digit Symbol Coding number correct derived from principal components analyses

Time Frame

change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months

Secondary Outcome Measure Information:

Title

Central Auditory Processing

Description

Time Frame

change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months

Title

Everyday Function

Description

A composite will be formed from the time and accuracy of performance on the Timed IADL Test and The Test of Everyday Attention (TEA)

Time Frame

change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months

Other Pre-specified Outcome Measures:

Title

General Self Efficacy

Description

General Self-Efficacy scale likert scaling with higher numbers reflecting better self efficacy. 23 items on a 14-point scale. Items will be summed. Items are designed to reflect effort, initiation, and persistence as described by Bandura

Time Frame

Change from prior to training content exercises to immediately after training content exercises, at the end of intervention phase which is about three months

Title

Music Self Efficacy

Description

Music Self-Efficacy scale likert scaling with higher numbers reflecting better music self efficacy. 24 items with liker scaling of 1 to 100. Total across all items will be summed. Items reflect the degree to which participants have positive feelings and beliefs in their musical abilities.

Time Frame

Change from prior to training content exercises to immediately after training content exercises, at the end of intervention phase which is about three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: aged 60 years or older willingness to provide informed consent willingness to complete up to 23 study visits including attending in-lab intervention two times a week for a three-month period with the goal of completing 20 sessions. ability to speak and understand English Montreal Cognitive Assessment score of 20 or higher (score 20 to 30 inclusive) intact vision (binocular near visual acuity of 20/50 or better tested with a standard near visual acuity chart) adequate hearing acuity (no greater than a moderate hearing loss [thresholds <70 dB HL] in the mid-frequency range [1000, 2000 Hz] in at least one ear as determined by a standard pure tone hearing evaluation) Music Reading Assessment score of 18 or lower (score 0-18 inclusive) ability to understand study procedures and comply with them for the length of the study in the tester's opinion (and other study personnel opinion who interact with participant, such as the study physician) Exclusion Criteria: moderate or worse depressive symptoms (Geriatric Depression Scale short form score >=5) previous participation in University of South Florida (USF) Cognitive Aging Lab intervention studies previous participation in 10 or more hours of a computerized cognitive intervention computer programs (e.g., Lumosity, Posit Science Brain Fitness, InSight, or BrainHQ; Lace, CogMed, CogniFit, Happy Neuron, Dakim, DriveSharp or Staying Sharp programs) currently enrolled in another research study planning on being away for two or more weeks during the next five months (recruit later) undergoing chemotherapy or radiation treatment or planning surgeries or other procedures requiring anesthesia within the next five months (recruit later) four or more years of formal music training such as private lessons or group lessons on a specific instrument ability to read music on two or more of the following clefs: Treble clef, Bass clef, Alto clef four or more years of playing any one musical instrument currently practicing or participating in any music activities- such as music performance or music reading or music lessons difficulty and pain in moving hands or fingers, or neuropathy affecting hands, or tremor in either hand self-reported diagnosis of dementia, stroke, serious brain injury or neurological disorder diagnosed by a physician or nurse with a TIA that occurred within the last 18 months inability or unwillingness to give written informed consent at baseline Clinical Dementia Rating Scale score of 1 or greater Clinical diagnosis of dementia or other disorder that in the study physician's opinion would limit the persons ability to participate in the study or benefit from the interventions

Facility Information:

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33620

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31226405

Citation

Hudak EM, Bugos J, Andel R, Lister JJ, Ji M, Edwards JD. Keys to staying sharp: A randomized clinical trial of piano training among older adults with and without mild cognitive impairment. Contemp Clin Trials. 2019 Sep;84:105789. doi: 10.1016/j.cct.2019.06.003. Epub 2019 Jun 18.

Results Reference

derived

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Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp

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