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Alzheimer DiseaseiSTEP+NCT06496425

Inspiring Seniors Towards Exercise Promotion to Protect Cognition

A study testing Beat-accentuated, personalized music stimulation (BMS), Strength Training (ST) and Aerobic exercise (AE) in people with Alzheimer Disease and Physical Activity, run by Emory University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 with subjective memory complaints. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease, Physical Activity
What is being tested?
Beat-accentuated, personalized music stimulation (BMS), Strength Training (ST) and Aerobic exercise (AE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
15 May 2024to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Team contact

404-727-8919

istep@emory.edu

United States2 sites, 1 recruiting
  • Emory University

    Atlanta, Georgia, 30324

    Study Team, 404-727-8919, istep@emory.edu

    Kyoung Shin Park, PhD

    Recruiting
  • UNC Greensboro

    Greensboro, North Carolina, 27412

    Completed

Other trials in United States

About this study

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).

Read the detailed description

Regular physical activity (PA) is associated with numerous health benefits including improved muscular and cardiorespiratory fitness, cognitive functioning, and quality of life (QoL). Hence, national PA guidelines (PAG) have been disseminated to recommend regularly engaging in moderate-to-vigorous aerobic exercise (AE) and muscle-strengthening training (ST). However, adherence to the PAG steeply declines after ages 60-65,1-5 at the time when health benefits of PA become pronounced. Fewer than 20% of US older adults adhere to the national guidelines for both AE and ST.

PA promotion is particularly urgent in older adults who are experiencing subjective cognitive complaints (SCC) and thereby have a heightened risk of Alzheimer's disease. SCC refers to self-perceived worsening of memory or other cognitive capacities in the previous year, independent of cognitive testing or clinical diagnosis, and is known to be an important prognostic symptom of Alzheimer's Disease (AD). According to the latest national survey, ~10% of US adults aged > 45 years reported SCC and, of those with SCC, 43.6% do not engage in any PA outside of work.

A major challenge to promoting multicomponent PA is that many sedentary people have a negative affective attitude toward moderate AE and ST. This negative affective response is a critical barrier to the maintenance of regular PA because, in general, people are unlikely to continue a behavior that results in immediate displeasure. Listening to music during acute bouts of PA increases positive effects and reduces perceived exertion. However, for these benefits to translate to long-term adherence, music alone is not sufficient. Beat-accented music stimulation (BMS) is an application of pulsed, tempo-synchronous music stimuli for the facilitation of rhythmic body movements. BMS has shown effects on increasing the weekly volume of PA in midlife-to-older adults undergoing cardiac rehabilitation whereas beat-unaccented music had little effect on PA outcomes. This proof-of-concept has not been tested in low-active older adults and the psychological mechanisms of PA behavior change remain unknown.

Participants will be randomized to an exercise intervention with or without BMS (MEX vs. EX), both offering the same exercise prescription to foster independent adherence to the PAG through the gradual withdrawal of supervised training. The exercise intervention lasts for 6 months.

Being tested
Beat-accentuated, personalized music stimulation (BMS), Strength Training (ST), Aerobic exercise (AE)
Keywords
music, aerobic exercise, strength training, cognition, physical activity, muscular strength, memory complaint
Medical subject headings
Alzheimer Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beat-accentuated, personalized music stimulation (BMS)Behavioural

    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.

  • Strength Training (ST)Behavioural

    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.

  • Aerobic exercise (AE)Behavioural

    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.

Study groups in NCT06496425
Study groupRoleWhat they receive
Exercise intervention with beat-accentuated, personalized music stimulation (BMS)ExperimentalCognitively unimpaired, physically low-active older adults with subjective cognitive complaints are provided with a 6-month exercise intervention with beat-accentuated, personalized music stimulation (BMS).
Receives: Behavioral: Beat-accentuated, personalized music stimulation (BMS); Behavioral: Strength Training (ST); Behavioral: Aerobic exercise (AE)
Exercise intervention without BMSActive comparatorCognitively unimpaired, physically low-active older adults with subjective cognitive complaints are provided with a 6-month exercise intervention without beat-accentuated, personalized music stimulation (BMS).
Receives: Behavioral: Strength Training (ST); Behavioral: Aerobic exercise (AE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT

    Duration, intensity, and frequency of physical activity assessed using a waist-worn accelerometer.

    Measured: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6

  2. Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale (PACES)

    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.

    Measured: At baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)

  3. Affective attitude toward physical activity, perceived exertion, planned and actual physical activity, and physical activity settings

    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.

    Measured: 4 days at baseline and months 1, 2, 3, 4, 5, and 6

  4. Adherence to the physical activity program

    Daily duration of aerobic exercise and strength training is self-reported on an exercise log.

    Measured: A daily exercise log for the entire 6-month period

Secondary outcomes (16)
  1. General cognition as assessed using the Montreal Cognitive Assessment (MoCA)

    Montreal Cognitive Assessment takes approximately 10 minutes for completion and the total score ranges from 0 to 30.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  2. Executive function as assessed using the Tower of London - Freiburg version

    Tower of London - Freiburg version takes approximately 14 minutes to complete and measures the total number of items solved in minimum number of moves in the range from 0 to 12.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  3. Executive function as assessed using the NIH Toolbox Flanker Inhibitory Control and Attention test

    The Flanker Inhibitory Control and Attention test takes approximately 5 minutes to complete and measures the accuracy and reaction time to create a composite score, ranging from 0 to 10.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  4. Executive function as assessed using the NIH Toolbox Dimensional Change Card Sort test

    The Dimensional Change Card Sort test takes approximately 5 minutes to complete and measures the accuracy and reaction time to create a composite score, ranging from 0 to 10.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  5. Executive function as assessed using the NIH Toolbox List Sorting Working Memory test

    The List Sorting Working Memory test takes approximately 10 minutes to complete and measures the total number of items correctly recalled and sequenced, ranging from 0 to 26.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  6. Episodic memory as assessed using the NIH Toolbox Picture Sequence Memory test

    The Picture Sequence Memory test takes approximately 7 minutes to complete and measures the total number of items correctly placed, ranging from 0 to 31, and the IRT-based theta score, ranging from 200 to 700.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  7. Episodic memory as assessed using the Mnemonic Similarity Task

    This custom-developed test takes approximately 15 minutes to complete and measures mnemonic discrimination (a score ranging from 0-1) and visual recognition (a score ranging from 0-1).

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  8. Health-related quality of life as assessed using the RAND 36-Item Short-Form Health Survey (SF-36)

    The RAND 36-Item Short-Form Health Survey Scale has 36 items for self-report, takes 10-15 minutes to complete, and measures health-related quality of life with a score ranging from 0 - 100.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  9. Physical activity behaviors as assessed by physical activity and sedentary behavior questionnaire

    The physical activity and sedentary behavior questionnaire has 7 items and takes approximately 5 minutes for completion.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  10. The progress of aerobic capacity and endurance as assessed by 6-minute walk test

    The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  11. The progress of balance, sit-to-stand, and walking as assessed by Timed Up and Go test

    The time taken to complete a Timed Up and Go test is an indicator of fall risks.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  12. The progress of lower-body strength as assessed by 30-Second Sit-to-Stand test

    The number of sit-to-stand maneuvers completed in 30 seconds.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  13. The progress of upper-body strength as assessed by Grip Strength test

    The squeeze power in pounds measured by a handheld dynamometer.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  14. The progress of balance as assessed by 4-Stage Balance Test

    The duration of maintaining 4 difference postures.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  15. Individual differences in music-related reward experiences as assessed by the Barcelona Music Reward Questionnaire (BMRQ)

    BMRQ has 24 items and takes 5-10 minutes to complete and measures music-related reward experiences with a score ranging from 0 to 100.

    Measured: At pre-test (before the intervention) and post-test (within 4 weeks after the intervention)

  16. Treatment satisfaction as assessed by the iSTEP Satisfaction Survey (iSTEP-SS)

    iSTEP-SS has 25 items and takes up to 5 minutes to complete and measure participants' perceived accessibility, social support, confidence, and satisfaction with the intervention.

    Measured: At post-test (within 4 weeks after the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2024
  2. Study start15 May 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06496425
Sponsor's protocol ID
STUDY00008531
Other IDs
AARF-23-1145107, 2025P013046
Acronym
iSTEP+
Status last verified
Apr 2026
First submitted
12 Jun 2024
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36760458

Questions about this trial

What is this clinical trial studying?

A study testing Beat-accentuated, personalized music stimulation (BMS), Strength Training (ST) and Aerobic exercise (AE) in people with Alzheimer Disease and Physical Activity, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Team (404-727-8919, istep@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06496425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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