Expired Study
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Tampa, Florida 33620


Purpose:

This project evaluates the effects of piano training and computerized cognitive training on cognitive performance in healthy older adults compared to controls. The project is intended for healthy older adults (60-80 years) with little to no previous musical training (less than three years of prior musical training or cognitive training and not currently engaged in music reading or musical performance, less than 10 hours of previous cognitive training). Investigators anticipate that musical engagement will serve as an enjoyable cognitive intervention for older adults. Investigators believe that piano training will enhance cognitive performance on executive functions essential for maintaining independence in older adulthood. Learning a musical instrument, while challenging, will improve self-efficacy, mood, and qualtiy of life. Participants engaged in piano training will demonstrate reduced cortisol levels and increased immune function responses. Investigators predict that adults enrolled in computerized cognitive training will demonstrate enhanced memory, working memory and self-efficacy post-training.


Study summary:

The project purpose is to scientifically examine the benefits of piano training as compared to computer cognitive training and no treatment controls on cognitive (processing speed, task-switching, verbal fluency, verbal memory, and working memory), psychosocial (mood, self-efficacy, and quality of life), and physiological variables (biomarkers) in healthy older adult participants in a randomized clinical trial design. Participants: Ninety community dwelling older adults will be recruited from the community. Criteria for enrollment are: between the ages of 60-80, native English speakers, not currently taking medications affecting memory performance, have no pre-existing cognitive impairment or neurological disorders, (as indicated by the Telephone Interview for Cognitive Status > 30), no moderate to severe depression (as indicated by the Geriatric Depression Scale), no difficulty with hand movements, less than three years of prior musical training, not currently engaged in music reading or musical performance, and less than ten hours of prior computer brain training experience. Participants will be randomly assigned to one of three groups stratified by intelligence and gender: piano instruction, computerized cognitive training or a no treatment control group. Informed written consent will be obtained in accordance with the Institutional Review Board. Procedure: Participants will be tested in three visits: pre-training, immediately post-training, and three months follow-up. Those randomized to piano training or computerized cognitive training will complete their assigned training between pre-training and post-training visits. Measures of music aptitude and intelligence will be administered at the pre-training visit. These factors can influence cognitive performance. Any significant differences at baseline between the three assigned groups will be statistically controlled for in the analyses. Standardized cognitive measures will be used to examine processing speed, task-switching, verbal fluency, verbal memory, and working memory at each visit. Psychosocial outcomes (mood, self-efficacy, and quality of life) and physiological biomarkers will also be evaluated at each visit. The goal for both interventions will be to complete 48 hours of group training over a four month period (16 weeks). Sixty participants (30 piano training; 30 auditory computer training) will be asked to attend three hours of training each week. Thirty participants will serve in the no treatment control group. Piano training will consist of basic piano technique, dexterity exercises, piano literature, and music theory. Participants will be expected to perform all major scales, repertoire from the Alfred All-in-One Method, and complete weekly theory assignments. Each class session is structured as a cognitive intervention that focuses upon review of materials (15-20 min), and the remaining portion of the class focuses upon learning new skills and concepts. Computerized cognitive training involves computerized perceptual practice exercises that vary in difficulty ranging from basic auditory processing speed to application through memory exercises. Within each exercise, the stimuli (i.e., tones, speech sounds, words, sentences) become less discriminable and speed of presentation increases (making the exercises more difficult) as performance improves. The Brain Fitness training program with working memory exercises will be used. Data source(s). Data will consist of a series of standardized cognitive, psychosocial, and neurophysiological measures administered at three time points: pre-training, post-training, and at a three month follow-up. All standardized measures have been previously used to assess the efficacy of cognitive training approaches and demonstrate good psychometric properties.


Criteria:

Inclusion Criteria: - Between the ages of 60-80 - native English speakers - no pre-existing cognitive impairment or neurological impairment - not taking medications affecting memory performance (sleep meds, antidepressants, etc.) - Telephone Interview for Cognitive Status (score >30) - no moderate to severe depression - no difficulty with hand movements - less than three years of formal music training - no difficulty with the movement of their hands - not currently engaged in music reading or musical performance - < 10 hours of previous cognitive training Exclusion Criteria: - Those not between 60-80 - those taking medications affecting memory performance - Non-Native English Speakers - Those with pre-existing cognitive impairment - Telephone Interview for Cognitive Status (score < 30) - Those with difficulty in the movement of their hands - Those with more than three years of formal music training or currently engaged in music reading or music performance - Those with more than ten hours of cognitive training


Study is Available At:


Original ID:

19415


NCT ID:

NCT02564601


Secondary ID:


Study Acronym:


Brief Title:

The Impact of Piano Training on Cognitive Performance and Psychosocial Well-Being in Older Adults


Official Title:

The Impact of Piano Training on Cognitive Performance and Psychosocial Well-Being in Older Adults


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

60 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of South Florida


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

93


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jennifer Bugos, PhD
Principal Investigator
Assistant Professor

Study Dates

Start Date:June 2015
Completion Date:June 2017
Completion Type:Actual
Primary Completion Date:June 2017
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 29, 2019
First Received Date:September 16, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:N-Back
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Working Memory Measure in the Visual Domain
Outcome Type:Primary Outcome
Measure:Cued Color Word Stroop
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Cognitive Control, Inhibition
Outcome Type:Primary Outcome
Measure:Digit Coding- WAIS IV subtest
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Simple Processing Speed
Outcome Type:Primary Outcome
Measure:Symbol Search- WAIS IV subtest
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Visual Scanning
Outcome Type:Primary Outcome
Measure:Paced Auditory Serial Addition Task (PASAT)
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Complex processing speed
Outcome Type:Primary Outcome
Measure:Rey Auditory Verbal Learning Test
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Verbal Memory
Outcome Type:Primary Outcome
Measure:Delis Kaplan Executive Function Verbal Fluency subtest
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Category Fluency, Letter Fluency, Category Switching
Outcome Type:Primary Outcome
Measure:Trail Making Test
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Planning and Processing Speed
Outcome Type:Primary Outcome
Measure:Finger Tapper Test
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Motor Speed
Outcome Type:Primary Outcome
Measure:Salivary Cortisol
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Stress Levels
Outcome Type:Primary Outcome
Measure:SIgA levels
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Immune Function
Outcome Type:Primary Outcome
Measure:Musical Performance Self-Efficacy
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Musical Self-Efficacy
Outcome Type:Primary Outcome
Measure:General Self-Efficacy
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:General Self-Efficacy
Outcome Type:Primary Outcome
Measure:Cognitive Self-Report Questionnaire (25)
Time Frame:(CHANGE) up to 16 weeks and after study completion 7 months
Safety Issues:False
Description:Mood

Study Interventions

Intervention Type:Behavioral
Name:Piano Training
Description:The intervention focuses upon progressively difficult piano performance exercises (repertoire), technique, and finger dexterity exercises.
Arm Name:A1 Piano Training
Intervention Type:Behavioral
Name:Computer Cognitive Training
Description:The intervention focuses upon progressively difficult perceptual exercises using the Brain Fitness program plus working memory exercises.
Arm Name:A2 Computer Cognitive Training

Study Arms

Study Arm Type:Experimental
Arm Name:A1 Piano Training
Description:16 weekly classes will be provided to the piano training group. Each piano class session will focus upon review of materials (15-20 min), and the remaining portion of the class will focus upon learning new skills and concepts. This course includes finger dexterity exercises, basic piano technique, and basic piano repertoire.
Study Arm Type:Experimental
Arm Name:A2 Computer Cognitive Training
Description:16 weekly classes will be provided to the computerized cognitive training group. Computerized cognitive training involves process-based computerized practice of adaptive perceptual exercises. Each computer cognitive training class session will focus upon practice of cognitive exercises that vary in difficulty ranging from basic auditory processing speed to application through memory and working memory exercises. Within each exercise, the stimuli (i.e., tones, speech sounds, words, sentences) bec
Study Arm Type:No Intervention
Arm Name:A 3 No Treatment Controls
Description:No classes will be provided to our control group. This is a no-treatment control group.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of South Florida

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
PMID:19220558
Reference Type:Results Reference
Citation:Duff K, Tometich D, Dennett K. The Modified Telephone Interview for Cognitive Status is More Predictive of Memory Abilities Than the Mini-Mental State Examination. J Geriatr Psychiatry Neurol. 2015 Sep;28(3):193-7. doi: 10.1177/0891988715573532. Epub 2015 Feb 26.
PMID:25722349
Reference Type:Results Reference
Citation: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.
PMID:17612811

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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