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Cognitively Normal Older AdultsiSTEPNCT06364189

Inspiring Seniors Toward Exercise Promotion

A study testing Music and Exercise in people with Cognitively Normal Older Adults, run by University of North Carolina, Greensboro at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2)… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitively Normal Older Adults
What is being tested?
Music and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesUnited States
Study dates
15 May 2024to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • At least 65 years old.
  • Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane.
  • 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 (6 months).
  • Having a reliable means of transportation.
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  • Having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training.
  • Having no diagnosis or symptoms of cognitive impairment.
  • Having no symptoms of suicidal ideation and not meeting criteria for depressive disorder.
  • Physically low-active by doing < 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months.

Who cannot join

  • Diagnosis of neurological disorder or spinal cord disorder.
  • Known exercise contraindications.
  • Current cancer treatment.
  • Stroke or neural impairment in the past 6 months.
  • Hip/knee/spinal fracture or surgery in the past 6 month.
  • Unable or unwilling to attend intervention classes 3x/week in Months 1-2 and 1x/week in Months 3-4.
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  • Currently participating in any other physical activity or fitness-related research study.
  • Use of medication for Alzheimer's disease.
  • Change in dosage of medications prescribed for anxiety or depression within the previous 6 months.
  • Regularly drink > 14 alcoholic beverages a week or current illicit drug use.
  • Having no diagnosis or symptoms of cognitive impairment.
  • Meet the threshold for clinical depression.
  • Uncorrected hearing or visual impairments.
  • Unable to understand the study procedures.
  • One of the household members is participating in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University

    Atlanta, Georgia, 30324

  • University of North Carolina at Greensboro

    Greensboro, North Carolina, 27402-6170

Other trials in United States

About this study

Official title: Unraveling the Mechanisms of a Novel Music Intervention for Physical Activity Promotion in Older Adults

The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.

To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing >150min/week AE and 3 days/week of ST for 30 min/day.

Being tested
Music, Exercise
Keywords
music, aerobic exercise, strength training, cognitive performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MusicBehavioural

    Individualized play lists of music with the beats accentuated will be developed at a range of cadences. The music intervention is such that during strength training participants will be asked to sync their concentric and eccentric muscle contractions in time with the tempo of playlists. For aerobic exercise (AE), the tempo of playlists will be adjusted to match individual walking cadence for participants to be trained to walk in sync with the beats of the playlists.

  • ExerciseBehavioural

    The ST incorporates single-leg exercises for balance training and training with resistance bands and body weight.

    For aerobic exercise (AE), participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week.

Study groups in NCT06364189
Study groupRoleWhat they receive
Exercise and music stimulationExperimentalParticipants are given an aerobic and strength training program with faded supervision across 6 months. For aerobic exercise (AE), participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week. Participants will be trained to walk in synchrony with the beats of their personalized playlists. The strength training (ST) incorporates single-leg exercises for balance training and training with resistance bands and body weight. During the ST, participants will be asked to synchronize their concentric and eccentric muscle contractions in time with the tempo of BMS playlists at a specific beats-per-minute rhythm.
Receives: Behavioral: Music; Behavioral: Exercise
Exercise onlyActive comparatorParticipants are given an aerobic and strength training program with faded supervision across 6 months. The ST incorporates single-leg exercises for balance training and training with resistance bands and body weight. For aerobic exercise (AE), participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week.
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity (objective)

    Physical activity behavior assessed using accelerometry

    Measured: Accelerometers will be worn for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  2. Ecological Momentary Assessment (EMA): Affective response to PA

    Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA.

    Measured: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  3. Ecological Momentary Assessment (EMA): Perceived autonomy

    Assesses participant's perceived autonomy over exercise behavior.

    Measured: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  4. Ecological Momentary Assessment (EMA): Perceived exertion

    Assesses participant's perceived exertion during PA.

    Measured: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  5. Ecological Momentary Assessment (EMA): Behavioral intention

    Assesses degree to which participant intends to engage in PA.

    Measured: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  6. Ecological Momentary Assessment (EMA): Physical Activity setting

    Assessed the physical and social setting in which a participant engages in physical activity.

    Measured: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  7. Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect

    Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels.

    Measured: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  8. Ecological Momentary Assessment (EMA): Social Support for Exercise

    Measures with whom a person is exercising

    Measured: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.

  9. Physical activity (self-report)

    Aerobic exercise and strength training self-reported

    Measured: Will be reported daily from the first day of the intervention to the last day of the intervention (6 months)

Secondary outcomes (23)

  1. Cognitive performance - General

    Assessed using the Montreal Cognitive Assessment. Scores range from 0-30 with a higher score indicative of a better outcome.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  2. Cognitive performance - Tower of London

    Assessed using the Tower of London test. Both accuracy and reaction time are recorded with higher scores for accuracy and lower scores for reaction time indicative of a better outcome.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  3. Cognitive performance - NIH Toolbox Oral Reading Recognition Test

    Assessed using the NIH Toolbox Oral Reading Recognition Test

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  4. Cognitive performance - NIH Toolbox List Sort Working Memory Test

    Assessed using the NIH Toolbox List Sort Working Memory Test

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  5. Cognitive performance - NIH Toolbox Picture Sequence Test

    Assessed using the NIH Toolbox Picture Sequence Test

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  6. Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test

    Assessed using the NIH Toolbox Dimensional Change Card Sort Test

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  7. Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test

    Assessed using the NIH Toolbox Flanker Inhibitory Control and Attention Test

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  8. Cognitive performance - Mnemonic Similarity Task

    Assessed using the Mnemonic Similarities Task

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  9. Cognitive performance - Perceptual Discrimination Task

    Assessed using the Perceptual Discrimination Task

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  10. Health Related Quality of Life

    Assessed using the RAND 36-Item Short-Form Health Survey with scores ranging from 0-100 and a higher score being indicative of a better outcome.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  11. Physical activity (subjective)

    Physical activity behavior is assessed using the Physical Activity and Sedentary Behavior Questionnaire (PASB-Q) which includes open-ended questions to assess frequency of physical activity and multiple choice questions to assess perceived fitness and sedentary behaviors.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  12. Music Reward Experience

    Music Reward Experience will be assessed using the Barcelona Music Reward Questionnaire (BMRQ) which uses a 5-point Likert scale. Responses are converted to z-scores which are then combined into factor scores and converted into T-scores ranging from 0-100 with a higher score meaning a more positive experience.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  13. Treatment Satisfaction

    Treatment Satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-8) with scores ranging from 8-32 and a higher score being indicative of a better outcome.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  14. Body Mass Index

    Body mass index will be assessed as a ratio of weight to height with measurements taken in the lab setting.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  15. Waist/Hip/Leg Circumference

    Waist/Hip/Leg Circumference will be assessed using a measuring tape.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  16. Sagittal Diameter

    Sagittal Diameter will be assessed using a measuring tape.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  17. Blood Pressure

    Systolic and diastolic blood pressure will be assessed using an automated blood pressure cuff.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  18. Handgrip Strength

    Handgrip Strength will be assessed using a goniometer.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  19. Timed Up and Go (TUG)

    Timed Up and Go (TUG) will be assessed using standard instructions asking participants to stand up from a seated position, to walk 3-meters, turn around, return 3-meters, turn around, and sit back down. Performance is the time needed to complete the task.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  20. 10-Meter Walk

    10-Meter Walk will be assessed with a stop watch over a clearly marked 10-meter distance.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  21. 4-Stage Balance Test

    4-Stage Balance Test will be assessed using standard directions. Duration of the ability to stand in 4 different poses with eyes open and without changing posture.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  22. 6-Minute Walk Test (6MWT)

    6-Minute Walk Test (6MWT) will be assessed as the distance travelled in 6-minutes around a clearly marked space in a gymnasium.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

  23. 30-second Chair Stand

    The number of sit-to-stand maneuvers that can be completed within 30 seconds.

    Measured: At pre-test and following study completion (approximately 6 months after pre-test)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start15 May 2024
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

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
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06364189
Sponsor's protocol ID
FY22-119
Other IDs
R61AG084479
Acronym
iSTEP
Status last verified
Dec 2025
First submitted
29 Mar 2024
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park KS, Williams DM, Etnier JL. Exploring the use of music to promote physical activity: From the viewpoint of psychological hedonism. Front Psychol. 2023 Jan 25;14:1021825. doi: 10.3389/fpsyg.2023.1021825. eCollection 2023.

    PubMed 36760458

Questions about this trial

What is this clinical trial studying?

A study testing Music and Exercise in people with Cognitively Normal Older Adults, run by University of North Carolina, Greensboro at 2 sites 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (objective) (time frame: Accelerometers will be worn for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06364189, which also lists 1 linked publication.

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 8 Dec 2025.

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