Trial0

Clinical trial · NCT06496425 · RECRUITING · NA

Inspiring Seniors Towards Exercise Promotion to Protect Cognition

Sponsor: Emory University

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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. 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

  • Beat-accentuated, personalized music stimulation (BMS) · BEHAVIORAL

    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) · BEHAVIORAL

    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) · BEHAVIORAL

    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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (2)

  • Emory University, Atlanta, Georgia · RECRUITING
  • UNC Greensboro, Greensboro, North Carolina · COMPLETED

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-04-30.