Inspiring Seniors Toward Exercise Promotion

NCT06364189 | Completed DMC

• 2 other identifiers: FY22-119R61AG084479
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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) 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.

Conditions

Cognitively Normal Older Adults

Keywords

music; aerobic exercise; strength training; cognitive performance

Outcome Measures

Primary Outcomes (9)

• Physical activity (objective)

  Physical activity behavior assessed using accelerometry

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

• 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.

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

• Ecological Momentary Assessment (EMA): Perceived autonomy

  Assesses participant's perceived autonomy over exercise behavior.

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

• Ecological Momentary Assessment (EMA): Perceived exertion

  Assesses participant's perceived exertion during PA.

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

• Ecological Momentary Assessment (EMA): Behavioral intention

  Assesses degree to which participant intends to engage in PA.

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

• Ecological Momentary Assessment (EMA): Physical Activity setting

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

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

• 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.

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

• Ecological Momentary Assessment (EMA): Social Support for Exercise

  Measures with whom a person is exercising

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

• Physical activity (self-report)

  Aerobic exercise and strength training self-reported

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

Secondary Outcomes (23)

• Cognitive performance - General

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

• Cognitive performance - Tower of London

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

• Cognitive performance - NIH Toolbox Oral Reading Recognition Test

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

• Cognitive performance - NIH Toolbox List Sort Working Memory Test

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

• Cognitive performance - NIH Toolbox Picture Sequence Test

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

Study Arms (2)

Exercise and music stimulation

EXPERIMENTAL

Participants 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.

Behavioral: Music; Behavioral: Exercise

Exercise only

ACTIVE COMPARATOR

Participants 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.

Behavioral: Exercise

Interventions

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 and music stimulation

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.

Exercise and music stimulation; Exercise only

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Greensboro: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30324, United States

Location

University of North Carolina at Greensboro

Greensboro, North Carolina, 27402-6170, United States

Location

Related Publications (1)

• 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.

  PMID: 36760458 BACKGROUND

MeSH Terms

Interventions

Music Therapy; Exercise

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer L Etnier, PhD

  University of North Carolina, Greensboro

  PRINCIPAL INVESTIGATOR

• Kyoungshin Park, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 15, 2024
• Study Start: May 15, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)