Inspiring Seniors Towards Exercise Promotion - 2

NCT07629739 | Recruiting

• 2 other identifiers: 2025P011936R33AG084479
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Physical Activity; Exercise; Music; Cognitive decline prevention

Outcome Measures

Primary Outcomes (3)

• 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)

• 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.

  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.

  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

  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)

  At pre-test (before the intervention) and 6 weeks post-intervention

• Exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)

  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)

  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)

  Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)

Study Arms (2)

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.

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.

Behavioral: Exercise intervention without RAS (EX)

Interventions

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.

Exercise intervention with RAS (EX+RAS)

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.

Exercise intervention without RAS (EX)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kyoung Shin Park, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaetlin Marsh, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 5, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)