Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06364189 (iSTEP) for Cognitively Normal Older Adults is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One trial matched filter criteria
Card View
Inspiring Seniors Toward Exercise Promotion (iSTEP)
Clinical Trial NCT06364189 (iSTEP) is an interventional study for Cognitively Normal Older Adults that is active, not recruiting. It started on 15 May 2024 with plans to enroll 50 participants. Led by University of North Carolina, Greensboro, it is expected to complete by 30 August 2025. The latest data from ClinicalTrials.gov was last updated on 21 March 2025.
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.
Official Title
Unraveling the Mechanisms of a Novel Music Intervention for Physical Activity Promotion in Older Adults
Conditions
Cognitively Normal Older AdultsPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- iSTEP
- FY22-119
- R61AG084479 (U.S. NIH Grant/Contract)
NCT ID Number
Start Date (Actual)
2024-05-15
Last Update Posted
2025-03-21
Completion Date (Estimated)
2025-08-30
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
music
aerobic exercise
strength training
cognitive performance
aerobic exercise
strength training
cognitive performance
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExercise and music stimulation 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. | 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. |
Active ComparatorExercise only 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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
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) |
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) |
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) |
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) |
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) |
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) |
Cognitive performance - Mnemonic Similarity Task | Assessed using the Mnemonic Similarities Task | At pre-test and following study completion (approximately 6 months after pre-test) |
Cognitive performance - Perceptual Discrimination Task | Assessed using the Perceptual Discrimination Task | At pre-test and following study completion (approximately 6 months after pre-test) |
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) |
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) |
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) |
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) |
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) |
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) |
Sagittal Diameter | Sagittal Diameter will be assessed using a measuring tape. | At pre-test and following study completion (approximately 6 months after pre-test) |
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) |
Handgrip Strength | Handgrip Strength will be assessed using a goniometer. | At pre-test and following study completion (approximately 6 months after pre-test) |
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) |
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) |
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) |
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) |
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) |
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
University of North Carolina, GreensboroNational Institute on Aging (NIA)Study Responsible Party
Jennifer L. Etnier, Principal Investigator, Distinguished Professor, University of North Carolina, Greensboro
No contact data.
2 Study Locations in 1 Countries
Georgia
Emory University, Atlanta, Georgia, 30324, United States
North Carolina
University of North Carolina at Greensboro, Greensboro, North Carolina, 27402-6170, United States