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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02564601
Other study ID # 19415
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date June 2017

Study information

Verified date April 2019
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 — View 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 — View Citation

Outcome

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