Inspiring Seniors Toward Exercise Promotion

Cognitively Normal Older Adults Clinical Trial

— iSTEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364189
• Other study ID #: FY22-119
• Secondary ID: R61AG084479
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Greensboro
• Contact: Project Coordinator
• Phone: 336-334-4765
• Email: istep[@]uncg.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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 cognitive impairment.
• Having no self-perceived memory complaints.
• 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 cognitive impairment or memory complaints.
• 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.

Related Conditions & MeSH terms

• Cognitively Normal Older Adults

Intervention

Behavioral:
• Music
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
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.

Locations

Country	Name	City	State
United States	University of North Carolina at Greensboro	Greensboro	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Greensboro	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Cognitive performance - General	Assessed using the Montreal Cognitive Assessment. Scores range from 0-30 with a higher score indicative of a better outcome.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Cognitive performance - NIH Toolbox Oral Reading Recognition Test	Assessed using the NIH Toolbox Oral Reading Recognition Test	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Cognitive performance - NIH Toolbox List Sort Working Memory Test	Assessed using the NIH Toolbox List Sort Working Memory Test	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Cognitive performance - NIH Toolbox Picture Sequence Test	Assessed using the NIH Toolbox Picture Sequence Test	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test	Assessed using the NIH Toolbox Dimensional Change Card Sort Test	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test	Assessed using the NIH Toolbox Flanker Inhibitory Control and Attention Test	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Cognitive performance - Mnemonic Similarity Task	Assessed using the Mnemonic Similarities Task	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Cognitive performance - Perceptual Discrimination Task	Assessed using the Perceptual Discrimination Task	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Body Mass Index	Body mass index will be assessed as a ratio of weight to height with measurements taken in the lab setting.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Waist/Hip/Leg Circumference	Waist/Hip/Leg Circumference will be assessed using a measuring tape.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Sagittal Diameter	Sagittal Diameter will be assessed using a measuring tape.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Blood Pressure	Systolic and diastolic blood pressure will be assessed using an automated blood pressure cuff.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	Handgrip Strength	Handgrip Strength will be assessed using a goniometer.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	10-Meter Walk	10-Meter Walk will be assessed with a stop watch over a clearly marked 10-meter distance.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	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.	At pre-test and following study completion (approximately 6 months after pre-test)
Secondary	30-second Chair Stand	The number of sit-to-stand maneuvers that can be completed within 30 seconds.	At pre-test and following study completion (approximately 6 months after pre-test)