NCT06496425 · Emory University
Inspiring Seniors Towards Exercise Promotion to Protect Cognition
(iSTEP+)
What this study is about
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 with subjective memory complaints.
View original scientific description
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 with subjective memory complaints. 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 minutes per day) and aerobic exercise (AE) (30-50 minutes per day) session for 3 days per week for the first 2 months, 1 day per 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 \>150minutes per week AE and 3 days per week of ST for 30 minutes per day).
Interventions
BEHAVIORAL
Beat-accentuated, personalized music stimulation (BMS)
Participants receive pre-recorded music playlists to use during exercise. During the strength training (ST), participants are asked to sync their concentric and eccentric muscle contractions to the beats of the music at a specific tempo. During aerobic exercise (AE), the tempo is adjusted to match individual walking cadence for participants to step in sync with the playlists.
BEHAVIORAL
Strength Training (ST)
Most exercises for the ST are chair- or wall-assisted to be safely performed by older adults on their own and adaptable across fitness levels by using different resistance bands. ST are taught at in-person and virtual sessions. Repetitions are increased by 1 repetition every 2 to 3 weeks up to 1 set of 12 repetitions. Participants start the program using no band or the lowest-resistance band. Band level is increased gradually, individually for each participant, to help reduce the risk of injury and prevent excessive fatigue.
BEHAVIORAL
Aerobic exercise (AE)
At the beginning of the program, participants are asked to exercise 45 minutes per week spread over 3 sessions (15 minutes per session). Beginning at Week 4, a 5-minute increase in walking time per session occurs every 2 weeks until 30 minutes of walking is reached per session. Beginning at Week 10 the number of sessions per week increases until participants walk for 30 minutes 5 times per week, for a total of 150 minutes per week. Minutes per session and total minutes per week are guidelines. Participants may choose to increase or decrease daily or weekly exercise time based on their individual needs. Participants may choose to perform AE more than 150 minutes per week.
Primary outcome measures
Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT
Time frame: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6
Duration, intensity, and frequency of physical activity assessed using a waist-worn accelerometer.
Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale (PACES)
Time frame: At baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)
Self-reported affective states relative to physical activity. Physical Activity Enjoyment Scale has 18 items based on a 7-point Likert scale and the total score ranges from 18 to 126.
Affective attitude toward physical activity, perceived exertion, planned and actual physical activity, and physical activity settings
Time frame: 4 days at baseline and months 1, 2, 3, 4, 5, and 6
Concurrent, prospective, and retrospective affective attitude toward physical activity, perceived exertion, planned and actual physical activity, and physical activity settings as assessed by Ecological Momentary Assessment.
Adherence to the physical activity program
Time frame: A daily exercise log for the entire 6-month period
Daily duration of aerobic exercise and strength training is self-reported on an exercise log.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults at least 65 years old.
- Ambulatory/capable of walking without pain or the use of assisted walking devices.
- 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.
- Having a reliable means of transportation.
- Having a safe place at home or a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.
- Being low-active (\< 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months).
- Having SCC, defined by the Cognitive Change Index (CCI) ≥ 15.
Exclusion criteria
- Concurrent diagnosis of neurological disorder (e.g., dementia, Parkinson's disease, multiple sclerosis, stroke, etc.).
- Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions etc.).
- Current cancer treatment.
- Stroke or neural impairment in the past 6 months.
- Hip/knee/spinal fracture or surgery in the past 6 months.
- Unable or unwilling to attend intervention classes.
- Currently participating in any other physical activity or fitness-related research study.
- Use of medication for cognitive impairment.
- Regularly drink \> 14 alcoholic beverages a week or current illicit drug use.
- Meet the threshold for 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.
Where
- Atlanta, Georgia
- Greensboro, North Carolina
Collaborators
Alzheimer's Association, University of North Carolina, Greensboro
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations