Emory University
Atlanta, Georgia, 30329, United States
Location status: Recruiting
NCT Number: NCT07629739
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30329, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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)
Duration, intensity, and frequency of physical activity will be assessed using a waist-worn accelerometer.
Time frame: During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)
Self-reported daily duration and types of physical activity will be self-reported on an exercise log.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: At pre-test (before the intervention) and 6 weeks post-intervention
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.
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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.
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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).
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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).
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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.
Time frame: At pre-test (before the intervention) and post-test within 6 weeks after the intervention
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.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
The SphygmoCor XCEL system provides measurements on pulse wave velocity, which will serve as the outcome of interest in arterial fitness. It is measured in units of meters per second, at which blood pressure waves travel through the circulatory system.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Central aortic pressure measures blood pressure directly at the root of the aorta, and is measured in units of millimeters of mercury (mmHg).
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Measurements will be taken using the InBody380 scan.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Skeletal muscle mass will be measured using the InBody380 scan.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Body fat percentage (percent body fat) will be measured using the InBody380 scan.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
Time frame: During month 3 and 6 (during intervention) and 8 months (2 months post-intervention)
Auditory stimulation score as assessed by a 10-item custom-developed Playlist Rating survey Developed by the research team, this 10-item 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, where higher scores represent higher levels of auditory stimulation. The total score ranges from 5 to 35 for aerobic and strength training, with higher scores indicating greater auditory stimulation.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
The 10-meter walk test (10MWT) assesses gait speed by timing a patient walking a 6-meter distance, usually within a 10-meter path to allow for acceleration/deceleration. It is a standardized assessment for gait by measuring the time taken at the 2m and 8m markers during the timed, steady-state portion. This outcome measure reports gait speed in meters per second (m/s) at normal and brisk pace.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Hand Grip Strength as measured by a Jamar hand dynamometer. The squeeze power in kilograms is measured by a handheld Jamar dynamometer.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Standing balance (time held, in seconds) as assessed by the 4-Stage Balance Test.
The duration in seconds of maintaining 4 difference postures.
Time frame: At pre-test (before the intervention) and post-test, within 6 weeks after the intervention
The number of sit-to-stand maneuvers completed in 30 seconds.
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
The time taken to complete a Timed Up and Go test is an indicator of fall risks.
Contact information is provided by the study sponsor or research team.
Emory University
Other
Acronym: iSTEP-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07687316
Atrophy, Behavior
Kennesaw, Georgia, United States
View Trial DetailsNCT06476288
Behavior, Debility
Durham, North Carolina, United States
View Trial DetailsNCT06556537
Behavior, Frailty
Zaragoza, Spain
View Trial DetailsNCT06912607
American Sign Language, Behavior
Washington D.C., District of Columbia, United States
View Trial Details