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| ID | Type | Description | Link |
|---|---|---|---|
| R33AG084479 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment). Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-older adults during a cardiac rehab program. The purpose of this study is to determine how personalized, tempo-synchronous music playlists called rhythmic auditory stimulation (RAS) influence exercise behavior change and affective responses to exercise over 8 months among community-dwelling, sedentary older adults.
Participants 65 years and older will be offered an exercise program for six months, either with or without RAS. The exercise program is based on the national physical activity guidelines for older adults and designed to train participants to independently engage in strength training and moderate-intensity aerobic training through the gradual withdrawal of supervised exercise classes (2 days/week for 3 months and 1 day/week for an additional 3 months). At baseline, every month during the 6-month intervention, and 2-month post-intervention follow-up, we assess weekly volume of physical activity (primary outcome) using a hip-worn activity tracker and affective attitude toward physical activity (mechanistic outcome) through text-message-based ecological momentary assessment (EMA). Before and after the 6-month intervention, participants will complete a lab visit for the assessment of cognitive, vascular, and physical functioning, fitness, anthropometry, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention with RAS (EX+RAS) | Experimental | Participants will be randomized to an exercise intervention with RAS (EX+RAS) over 6 months, offering the exercise prescription to foster independent adherence to the Physical Activity guidelines (PAG) through the gradual withdrawal of supervised training. This group will be provided with RAS playlists and trained to use them for their exercise sessions. |
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| Exercise intervention without RAS (EX) | Active Comparator | Participants will be randomized to an exercise intervention (EX) over 6 months, offering the same exercise prescription as the experimental group, to foster independent adherence to the PAG through the gradual withdrawal of supervised training. This group will not be provided with any RAS playlists to accompany their exercise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise intervention with RAS (EX+RAS) | Behavioral | Supervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week. Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph | Duration, intensity, and frequency of physical activity will be assessed using a waist-worn accelerometer. | 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6 (during intervention) and month 8 (2 months post-intervention) |
| Physical activity behaviors as assessed by an Exercise Log | Daily duration and types of physical activity will be self-reported on an exercise log. | During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention) |
| The single-item Feeling Scale (FS) | The single-item Feeling Scale (FS) will be used to measure affective responses to physical activity as assessed by Ecological Momentary Assessment (EMA). How are you feeling right now? with 11-point rating scale scores ranging from -5 to +5, with labels -5 = very bad, -3 = bad, -1 = somewhat bad, 0 = neutral, +1 = somewhat good, +3 = good, and +5 = very good. | For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Borg's Rating of Perceived Exertion (RPE) scale | Borg's Rating of Perceived Exertion (RPE) scale will be used to assess perceived exertion during physical activity as assessed by Ecological Momentary Assessment (EMA). Scores range from 6 to 20, with verbal anchors of 7 = very, very light, 9 = very light, 11 = fairly light, 13 = somewhat hard, 15 = hard, 17 = very hard, and 19 = very, very hard. | For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
Concurrent diagnosis of neurological disorder (e.g., dementia, Parkinson's disease, multiple sclerosis, etc.), determined by self-report on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions, etc.), determined by self-report on the PAR-Q+.
Current or upcoming cancer treatment, determined by self-report on the PAR-Q+.
Stroke or neural impairment in the past 6 months, as self-reported on the PAR-Q+.
Hip/knee/spinal fracture or surgery in the past 6 months, determined by self-report on the ACSM Health Screening Questionnaire.
Unable or unwilling to attend intervention classes, as determined by phone screening.
Currently participating in any other exercise or fitness-related research study, determined by phone screening.
Use of medications for cognitive impairment, as self-reported on the medication survey.
Change in dosage of medications prescribed for anxiety or depression within the previous 6 months, determined by self-report on a medication form.
Self-report regularly drinking > 14 alcoholic beverages a week or current illicit drug use, determined by self-report to screening surveys.
Cannot ambulate without a walker/cane, assessed in the American College of Sports Medicine (ACSM) Health Screening Questionnaire
• Having cognitive impairment, determined by the Montreal Cognitive Assessment (MoCA) BLIND < 17.
Meet the threshold for clinical depression, determined by the Center for Epidemiological Studies Depression Scale Revised (CESD-R).
Uncorrected hearing or visual impairments, self-reported on the Health History Questionnaire.
Unable to understand the study procedure.
One of the household members is participating in this study, as self-reported during phone screening.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaetlin Marsh, MPH | Contact | 404-544-2381 | kaetlin.marsh@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kyoung Shin Park, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Recruiting | Atlanta | Georgia | 30329 | United States |
Researchers will share individual deidentified participant data that underlie the results reported from this trial (text, tables, figures, and appendices).
Data will be shared beginning 9 months following the article publication and will be available for at least 10 years after the end of the funding period.
Data will be shared with anyone who registers with the repository and agrees to its Terms of Use, which limit data use to scientific research and aggregate statistical reporting, prohibit attempts to re-identify study participants, and prohibit redistribution of downloaded data.
Data will be shared for any scientific research or aggregate statistical reporting consistent with the Terms of Use.
Data will be deposited in UNC Dataverse, which assigns a DOI as a persistent identifier and provides searchable study-level metadata for discovery. The dataset will be available for direct download through the repository interface upon registration and acceptance of the Terms of Use.
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| ID | Term |
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| D009043 | Motor Activity |
| ID | Term |
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| D001519 | Behavior |
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| Exercise intervention without RAS (EX) | Behavioral | Supervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week. Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up. |
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| Cognitive Change Index (CCI-12) | The Cognitive Change Index (CCI-12) is a 12-item questionnaire assessing self or informant-perceived decline in episodic memory over the past 5 years. It uses a 5-point Likert scale (1=no change, 5=much worse), with higher total scores (range 12-60) indicating greater perceived decline. It acts as a marker for dementia risk, subjective cognitive decline (SCD), and early Alzheimer's. The CCI-12 ranges from 12 to 60. Higher scores signify greater perceived decline. | At pre-test (before the intervention) and 6 weeks post-intervention |
| Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) | The Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) is a 19 to 24-item tool (commonly 23-24 items) used to assess motivation for physical activity based on Self-Determination Theory. It measures six types of motivation, ranging from not at all motivated to intrinsically motivated,. Likert Scale Range: 0 to 4 (0 = "Not true for me", 4 = "Very true for me"). Higher average scores (closer to 4) indicate that a particular regulation style is a strong reason for exercising. | Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention) |
| Physical Activity Enjoyment Scale (PACES) | Physical Activity Enjoyment Scale (PACES) to assess affective attitude toward PA. Self-reported affective states relative to physical activity. The Physical Activity Enjoyment Scale has 18 items on a 7-point Likert scale, and the total score ranges from 18 to 126. A total score of 63 can be used to distinguish between enjoyment (>63) and lack of enjoyment (<63). | Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention) |
| Self-Efficacy for Exercise Scale (SEE) | Self-Efficacy for Exercise Scale (SEE) is a self-report tool used to measure an individual's confidence in their ability to perform exercises regularly (e.g., 3 times per week for 20+ minutes) despite common barriers. The scale consists of 9 items. Scale: Each item is rated on an 11-point Likert scale ranging from 0 (Not Confident) to 10 (Very Confident). Minimum Score: 0 (representing zero confidence). Maximum Score: 90 (representing maximum confidence). Total Score Calculation: The total score is calculated by summing the responses to all 9 items. A higher total score indicates higher self-efficacy for exercise. 0-30: Low self-efficacy (low confidence in overcoming barriers to exercise). 31-60: Moderate self-efficacy. 61-90: High self-efficacy (high confidence in maintaining an exercise routine). | Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention) |
| Barriers to Being Active survey (BBA) | The Barriers to Being Active (BBA) survey is a 21-item questionnaire developed by the Centers for Disease Control and Prevention (CDC) to identify personal obstacles to exercise. It measures seven distinct categories of barriers, with each category containing 3 items. Each of the 21 questions is rated on a 4-point Likert scale: Very likely (3 points), Somewhat likely (2 points), Somewhat unlikely (1 point), Very unlikely (0 points). Since there are 3 questions per category, the minimum score is 0, and the maximum score is 9 per barrier. The minimum total score is 0, and the maximum total score is 63 (21 items × 3 points). Significant Barrier: A score of 5 or higher in any of the seven categories indicates that it is an important barrier to overcome. Low Barrier: A score below 5 indicates the barrier is less significant. | Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention) |
| Physical and Sedentary Behaviour Questionnaire (PASB-Q) | The Physical and Sedentary Behaviour Questionnaire (PASB-Q) is a tool used to assess an adult's typical weekly physical activity, muscle strengthening, and sedentary habits. It is not a single standardized 0-100 score, but rather a questionnaire that measures specific behaviors and can be used to gauge whether an individual meets physical activity guidelines. The questionnaire measures several aspects of physical activity. There is no set "maximum" score, as it measures frequency and duration, but the "minimum" is 0. It calculates the total minutes of moderate-to-vigorous aerobic physical activity per week. Minutes/day = Total Minutes/Week. Interpretation: Higher minutes per week indicate higher activity levels. | At pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| RAND 36-item Health Survey (RAND-36) | RAND 36-item Health Survey (RAND-36) to assess health-related quality of life. The RAND 36-Item Short-Form Health Survey Scale has 36 items for self-report, takes 10-15 minutes to complete, and measures health-related quality of life with a score ranging from 0 to 100, where 0 indicates the lowest possible health state (worst health), and 100 indicates the highest possible health state (best health). Higher scores always represent better health status. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to evaluate sleep quality over a one-month interval. It measures seven components of sleep, with a total global score ranging from 0 to 21. Minimum Score: 0 (Indicates no difficulty/excellent sleep quality).Maximum Score: 21 (Indicates severe difficulties in all areas/very poor sleep quality). Higher Score = Worse Sleep: A higher total score indicates poorer sleep quality. Scoring of 5: "Good" sleeper (low level of sleep disturbance) and > 5: "Poor" sleeper (indicates significant, relevant sleep disturbances) | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) | The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report questionnaire designed to measure the frequency and severity of depressive symptoms over the past two weeks. It is used to identify individuals who may need a further clinical evaluation for depression. Minimum Score (0): Indicates that the individual experienced almost no depressive symptoms, or that symptoms were present for less than one day, over the past two weeks. Maximum Score (80): Indicates high frequency and severity, suggesting all 20 symptoms were present nearly every day for the past two weeks. Total Score Range: The CESD-R uses a 5-point scale (0 to 4 per item), resulting in a total range of 0 to 80. A total score of >=16 or >= 17 generally indicates a risk for clinical depression or significant depressive symptoms. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| NIH Toolbox Perceived Stress Scale (PSS). | The NIH Toolbox Perceived Stress Scale (PSS) is a 10-item self-report questionnaire designed to measure how unpredictable, uncontrollable, and overloaded a person finds their life to be over the past month. The PSS is part of the NIH Toolbox Emotion Battery. Minimum Score (0): Indicates no perceived stress. Maximum Score (40): Indicates very high perceived stress. Calculation: Responses are scored on a scale of 0 (Never) to 4 (Very Often). Four positive items are reversed (0=4, 1=3, 2=2, 3=1, 4=0) before summing all 10 items for a total score. 0-13 (Low Stress): Below-average stress, generally feel in control. 14-26 (Moderate Stress): Average stress level, manageable but may warrant attention. 27-40 (High Stress): Elevated, high stress, often associated with poorer health outcomes. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Arterial fitness | Arterial fitness will be measured using a SphygmoCor system before and after the intervention. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Central aortic pressure | Central aortic pressures will be measured using a SphygmoCor system before and after the intervention. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Body Weight | Measurements will be taken using the InBody380 scan. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Skeletal muscle mass | Skeletal muscle mass will be measured using the InBody380 scan. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Body fat percentage | Body fat percentage (percent body fat) will be measured using the InBody380 scan. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Barcelona Music Reward Questionnaire (BMRQ) to assess music-related reward experiences | The Barcelona Music Reward Questionnaire (BMRQ) assesses music-related reward experiences. It consists of 20 items rated from 1 (completely disagree) to 5 (completely agree), with scores ranging from 0 to 100. Musical Anhedonia (Low): <= 65. These individuals derive little to no pleasure from music despite having normal hearing and cognitive function. Average/Normal Reward: 66 - 86. The majority of the population falls within this middle range. Hyperhedonia (High): >= 87. These individuals experience unusually strong emotional or physical responses to music. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Sagittal abdominal diameter | Measurements will be taken using a standardized anthropometric protocol (abdominal caliper) | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Waist, hip, and leg circumference | Measurements will be taken using a standardized anthropometric protocol (abdominal caliper) | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Playlist Rating survey | The auditory stimulation score is assessed using a 10-item custom-developed survey by the research team; this survey assesses the extent to which audio and video playlists motivate individuals in strength and aerobic training. Items are scored on a Likert-based scale (1 = Strongly Disagree, 7 = Strongly Agree). Scores are stratified by method of playlist administration (i.e., audio and video) and then summed, with higher scores representing a higher level of auditory stimulation. The total score ranges from 5 to 35 for aerobic and strength training, with higher scores indicating greater auditory stimulation. | During month 3 and 6 (during intervention) and 8 months (2 months post-intervention) |
| 10-meter walk tests to assess normal and brisk walking cadence | The 10-meter walk test (10MWT) assesses gait speed by timing a patient walking a 10-meter distance, usually within a 14-meter path to allow for acceleration/deceleration. The test measures gait speed in m/s, with cadence (steps/min) calculated by counting steps during the timed trial. It is a standardized assessment for gait. Count the number of steps taken between the 2m and 12m markers during the timed, steady-state portion. Studies show normal cadence is roughly 90 steps/min and brisk/fast cadence is roughly 140 steps/min. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| The progress of aerobic capacity and endurance as assessed by 6-minute walk test | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| Hand Grip Strength | The squeeze power in pounds measured by a handheld dynamometer. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| The progress of balance as assessed by 4-Stage Balance Test | The duration of maintaining 4 difference postures. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |
| The progress of lower-body strength as assessed by 30-Second Sit-to-Stand test | The number of sit-to-stand maneuvers completed in 30 seconds. | At pre-test (before the intervention) and post-test, within 6 weeks after the intervention |
| The progress of balance, sit-to-stand, and walking as assessed by Timed Up and Go test | The time taken to complete a Timed Up and Go test is an indicator of fall risks. | Pre-test (before the intervention) and post-test within 6 weeks after the intervention |