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Completed

NCT Number: NCT06364189

Inspiring Seniors Toward Exercise Promotion

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.

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Key information

Conditions

Cognitively Normal Older Adults

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Music

Behavioral

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.

Exercise

Behavioral

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.

Primary outcomes

  1. Physical activity (objective)

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

    Physical activity behavior assessed using accelerometry

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

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

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

  3. Ecological Momentary Assessment (EMA): Perceived autonomy

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

    Assesses participant's perceived autonomy over exercise behavior.

  4. Ecological Momentary Assessment (EMA): Perceived exertion

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

    Assesses participant's perceived exertion during PA.

  5. Ecological Momentary Assessment (EMA): Behavioral intention

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

    Assesses degree to which participant intends to engage in PA.

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

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

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

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

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

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

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

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

    Measures with whom a person is exercising

  9. Physical activity (self-report)

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

    Aerobic exercise and strength training self-reported

Secondary outcomes

  1. Cognitive performance - General

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

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

  2. Cognitive performance - Tower of London

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

    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.

  3. Cognitive performance - NIH Toolbox Oral Reading Recognition Test

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

    Assessed using the NIH Toolbox Oral Reading Recognition Test

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

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

    Assessed using the NIH Toolbox List Sort Working Memory Test

  5. Cognitive performance - NIH Toolbox Picture Sequence Test

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

    Assessed using the NIH Toolbox Picture Sequence Test

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

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

    Assessed using the NIH Toolbox Dimensional Change Card Sort Test

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

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

    Assessed using the NIH Toolbox Flanker Inhibitory Control and Attention Test

  8. Cognitive performance - Mnemonic Similarity Task

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

    Assessed using the Mnemonic Similarities Task

  9. Cognitive performance - Perceptual Discrimination Task

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

    Assessed using the Perceptual Discrimination Task

  10. Health Related Quality of Life

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

    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.

  11. Physical activity (subjective)

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

    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.

  12. Music Reward Experience

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

    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.

  13. Treatment Satisfaction

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

    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.

  14. Body Mass Index

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

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

  15. Waist/Hip/Leg Circumference

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

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

  16. Sagittal Diameter

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

    Sagittal Diameter will be assessed using a measuring tape.

  17. Blood Pressure

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

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

  18. Handgrip Strength

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

    Handgrip Strength will be assessed using a goniometer.

  19. Timed Up and Go (TUG)

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

    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.

  20. 10-Meter Walk

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

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

  21. 4-Stage Balance Test

    Time frame: At pre-test and following study completion (approximately 6 months after pre-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.

  22. 6-Minute Walk Test (6MWT)

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

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

  23. 30-second Chair Stand

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

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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Greensboro

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: iSTEP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2024
Registry last updated
Dec 8, 2025

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.

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