Recruiting

Exercise Promotion

Sponsor:

Emory University

Code:

NCT06496425

Conditions

Alzheimer Disease

Physical Activity

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Beat-accentuated, personalized music stimulation (BMS)

Strength Training (ST)

Aerobic exercise (AE)

Study Details

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 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).

Conditions

Alzheimer Disease

Physical Activity

Study ID

NCT06496425

Start date

May 15, 2024

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Exercise intervention with beat-accentuated, personalized music stimulation (BMS)

Cognitively 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).

active comparator: Exercise intervention without BMS

Cognitively 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).

Interventions

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.

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.

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 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 ]
  • 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) ]
  • 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 ]
  • Adherence to the physical activity program [ Time Frame: A daily exercise log for the entire 6-month period ]

Central Contacts and Locations

Central contacts

Study Team

404-727-8919istep@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30324

Contacts

Study Team

404-727-8919istep@emory.edu

Principal Investigator:

Kyoung Shin Park, PhD

More Information

Sponsor

Emory University

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • music
  • aerobic exercise
  • strength training
  • cognition
  • physical activity
  • muscular strength
  • memory complaint

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-30.