Old AgeiSTEP-2NCT07629739
Inspiring Seniors Towards Exercise Promotion - 2
A study testing Exercise intervention with RAS (EX+RAS) and Exercise intervention without RAS (EX) in people with Old Age, run by Emory University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age
- What is being tested?
- Exercise intervention with RAS (EX+RAS) and Exercise intervention without RAS (EX)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults over 65 years old.
- Ambulatory without pain or the use of assisted walking devices.
- Able to speak and read English.
- Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
- Living in the community for the duration of the study (9-10 months).
- Having a reliable means of transportation.
- Having a safe place at home or at a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.
- Being low-active (< 90 min/week of MAT and < 2 days/week of ST for the last 3 months).
Who cannot join
- Diagnosed progressive, neurodegenerative, or severe central nervous system disorders (e.g., Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, or history of stroke with residual deficits) that significantly impair cognitive function, motor skills, or the ability to engage in independent exercise training over moderate intensity
- Participants with a history of episodic or peripheral neurological conditions (such as neuralgia or migraines) or stable cardiovascular/metabolic conditions may be included if they receive formal written medical clearance from their primary care physician or treating specialist, confirming it is safe for them to engage in unsupervised exercise training at moderate intensity.
- 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.
Show all 18Show fewer
- 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.
- Initiation or change in dosage of psychiatric medications (e.g., antidepressants, anxiolytics) within the past 8 weeks; participants must be on a stable dose for at least 2 months before enrollment and intend to maintain this dose throughout the 8-month study period.
- Self-report regularly drinking > 14 alcoholic beverages a week or current illicit drug use, determined by self-report to screening surveys.
- Current regular or hazardous use of illicit substances, or misuse of prescription medications, that occurs on a weekly or more frequent basis, or any substance use that, in the judgment of the investigator, would systematically confound weekly affective assessments or compromise safety during unsupervised exercise training, 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30329
About this study
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.
Read the detailed description
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.
- Conditions
- Old Age
- Being tested
- Exercise intervention with RAS (EX+RAS), Exercise intervention without RAS (EX)
- Keywords
- Physical Activity, Exercise, Music, Cognitive decline prevention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise intervention with RAS (EX+RAS)Behavioural
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.
Exercise intervention without RAS (EX)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise intervention with RAS (EX+RAS) |
| 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. Receives: Behavioral: Exercise intervention without RAS (EX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Daily duration of aerobic and strenght training as recorded on an Exercise Log
Self-reported daily duration and types of physical activity will be self-reported on an exercise log.
Measured: During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)
Affective response to exercise measured by 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.
Measured: 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)
Secondary outcomes (28)
Perceived exertion measured by the 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.
Measured: 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)
Subjective cognitive decline measured by the 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.
Measured: At pre-test (before the intervention) and 6 weeks post-intervention
Exercise motivation measured by the 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.
Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Affective attitude toward physical activity measured by the 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).
Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Individual confidence in regular exercise measured by the 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).
Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Individual barriers in regular exercise measured by 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.
Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Physical activity and sedentary behaviors measured by 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.
Measured: At pre-test (before the intervention) and post-test within 6 weeks after the intervention
Health-related quality of life measured by 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.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Sleep disturbance measured by the 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)
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Depression measured by 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.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Perceived stress measured by the 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.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Arterial fitness (carotid-femoral pulse wave velocity) as measured by the SphygmoCor XCEL system
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.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Central aortic blood pressure (systolic and diastolic, mmHg) as measured by the SphygmoCor XCEL system
Central aortic pressure measures blood pressure directly at the root of the aorta, and is measured in units of millimeters of mercury (mmHg).
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Body Weight
Measurements will be taken using the InBody380 scan.
Measured: 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.
Measured: 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.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Music-related reward experiences measured by the 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.
Measured: 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)
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Waist circumference
Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Hip circumference
Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Leg circumference
Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
The auditory stimulation score
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.
Measured: During month 3 and 6 (during intervention) and 8 months (2 months post-intervention)
Gait speed at normal and brisk pace (meters/second) as assessed by the 10-Meter Walk Test (10MWT)
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.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Aerobic fitness as assessed by the total distance walked in 6-minute walk test
The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Hand Grip Strength
Hand Grip Strength as measured by a Jamar hand dynamometer. The squeeze power in kilograms is measured by a handheld Jamar dynamometer.
Measured: 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
Standing balance (time held, in seconds) as assessed by the 4-Stage Balance Test.
The duration in seconds of maintaining 4 difference postures.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Lower-body strength as assessed by 30-Second Sit-to-Stand test
The number of sit-to-stand maneuvers completed in 30 seconds.
Measured: 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.
Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start26 May 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kyoung Shin Park, PhD, Emory University
- Investigators
- Kyoung Shin Park, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629739
- Sponsor's protocol ID
- 2025P011936
- Other IDs
- R33AG084479
- Acronym
- iSTEP-2
- Status last verified
- Jul 2026
- First submitted
- 14 May 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers will share individual deidentified participant data that underlie the results reported from this trial (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiring Seniors Towards Exercise Promotion - 2
- ClinicalTrials.gov ID
- NCT07629739
- Acronym / sponsor ID
- iSTEP-2 / 2025P011936
- Conditions
- Old Age
- Keywords
- Physical Activity, Exercise, Music, Cognitive decline prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 May 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention with RAS (EX+RAS) | Experimental | Behavioral: Exercise intervention with RAS (EX+RAS)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. |
| Exercise intervention without RAS (EX) | Active comparator | Behavioral: Exercise intervention without RAS (EX)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Adults over 65 years old.
- Ambulatory without pain or the use of assisted walking devices.
- Able to speak and read English.
- Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
- Living in the community for the duration of the study (9-10 months).
Key exclusion criteria (18 listed)
- Diagnosed progressive, neurodegenerative, or severe central nervous system disorders (e.g., Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, or history of stroke with residual deficits) that significantly impair cognitive function, motor skills, or the ability to engage in independent exercise training over moderate intensity
- Participants with a history of episodic or peripheral neurological conditions (such as neuralgia or migraines) or stable cardiovascular/metabolic conditions may be included if they receive formal written medical clearance from their primary care physician or treating specialist, confirming it is safe for them to engage in unsupervised exercise training at moderate intensity.
- 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+.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise intervention with RAS (EX+RAS)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. | Behavioural | Exercise intervention with RAS (EX+RAS) |
| Exercise intervention without RAS (EX)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. | Behavioural | Exercise intervention without RAS (EX) |
Primary outcome
Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph
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.
Daily duration of aerobic and strenght training as recorded on an Exercise Log
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.
Affective response to exercise measured by the single-item Feeling Scale (FS)
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.
28 secondary outcomes
Perceived exertion measured by the Borg's Rating of Perceived Exertion (RPE) scale
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)
Subjective cognitive decline measured by the Cognitive Change Index (CCI-12)
Time frame: At pre-test (before the intervention) and 6 weeks post-intervention
Exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Affective attitude toward physical activity measured by the Physical Activity Enjoyment Scale (PACES)
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Individual confidence in regular exercise measured by the Self-Efficacy for Exercise Scale (SEE)
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Individual barriers in regular exercise measured by Barriers to Being Active survey (BBA)
Time frame: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
Physical activity and sedentary behaviors measured by Physical and Sedentary Behaviour Questionnaire (PASB-Q)
Time frame: At pre-test (before the intervention) and post-test within 6 weeks after the intervention
Health-related quality of life measured by RAND 36-item Health Survey (RAND-36)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Sleep disturbance measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Depression measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Perceived stress measured by the NIH Toolbox Perceived Stress Scale (PSS).
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Arterial fitness (carotid-femoral pulse wave velocity) as measured by the SphygmoCor XCEL system
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Central aortic blood pressure (systolic and diastolic, mmHg) as measured by the SphygmoCor XCEL system
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Body Weight
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Skeletal muscle mass
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Body fat percentage
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Music-related reward experiences measured by the Barcelona Music Reward Questionnaire (BMRQ) to assess music-related reward experiences
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Sagittal abdominal diameter
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Waist circumference
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Hip circumference
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Leg circumference
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
The auditory stimulation score
Time frame: During month 3 and 6 (during intervention) and 8 months (2 months post-intervention)
Gait speed at normal and brisk pace (meters/second) as assessed by the 10-Meter Walk Test (10MWT)
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Aerobic fitness as assessed by the total distance walked in 6-minute walk test
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Hand Grip Strength
Time frame: 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
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Lower-body strength as assessed by 30-Second Sit-to-Stand test
Time frame: 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
Time frame: Pre-test (before the intervention) and post-test within 6 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. Researchers will share individual deidentified participant data that underlie the results reported from this trial (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyoung Shin Park, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention with RAS (EX+RAS) and Exercise intervention without RAS (EX) in people with Old Age, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaetlin Marsh, MPH (404-544-2381, kaetlin.marsh@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.