Clinical trial NCT06364189: Inspiring Seniors Toward Exercise Promotion
Official title: Unraveling the Mechanisms of a Novel Music Intervention for Physical Activity Promotion in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitively Normal Older Adults
Keywords: music
aerobic exercise
strength training
cognitive performance
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity (objective)
timeFrame: Accelerometers will be worn for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Ecological Momentary Assessment (EMA): Affective response to PA
timeFrame: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Ecological Momentary Assessment (EMA): Perceived autonomy
timeFrame: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Ecological Momentary Assessment (EMA): Perceived exertion
timeFrame: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Ecological Momentary Assessment (EMA): Behavioral intention
timeFrame: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Ecological Momentary Assessment (EMA): Physical Activity setting
timeFrame: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect
timeFrame: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Ecological Momentary Assessment (EMA): Social Support for Exercise
timeFrame: Will be collected using EMA for 4 days at baseline and months 1, 2, 3, 4, 5, and 6.
measure: Physical activity (self-report)
timeFrame: Will be reported daily from the first day of the intervention to the last day of the intervention (6 months)
Secondary outcomes:
measure: Cognitive performance - General
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - Tower of London
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - NIH Toolbox Oral Reading Recognition Test
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - NIH Toolbox List Sort Working Memory Test
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - NIH Toolbox Picture Sequence Test
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - Mnemonic Similarity Task
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Cognitive performance - Perceptual Discrimination Task
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Health Related Quality of Life
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Physical activity (subjective)
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Music Reward Experience
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Treatment Satisfaction
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Body Mass Index
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Waist/Hip/Leg Circumference
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Sagittal Diameter
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Blood Pressure
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Handgrip Strength
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: Timed Up and Go (TUG)
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: 10-Meter Walk
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: 4-Stage Balance Test
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: 6-Minute Walk Test (6MWT)
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
measure: 30-second Chair Stand
timeFrame: At pre-test and following study completion (approximately 6 months after pre-test)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Greensboro
country: United States
facility: University of North Carolina at Greensboro
state: North Carolina
Study officials:
affiliation: University of North Carolina, Greensboro
name: Jennifer L Etnier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Kyoungshin Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.