Recruiting

Rhythmic Auditory Stimulation

Sponsor:

Emory University

Code:

NCT07629739

Conditions

Old Age

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Exercise intervention with RAS (EX+RAS)

Exercise intervention without RAS (EX)

Study Details

Brief 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 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.

Conditions

Old Age

Study ID

NCT07629739

Start date

May 26, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

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.

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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Kaetlin Marsh, MPH

404-544-2381kaetlin.marsh@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Physical Activity
  • Exercise
  • Music
  • Cognitive decline prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-23.