Inspiring Seniors Towards Exercise Promotion to Protect Cognition

NCT06496425 | Recruiting

• 3 other identifiers: STUDY00008531AARF-23-11451072025P013046
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

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

  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)

  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.

  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

  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.

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

• Adherence to the physical activity program

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

  A daily exercise log for the entire 6-month period

Secondary Outcomes (16)

• General cognition as assessed using the Montreal Cognitive Assessment (MoCA)

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

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

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

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

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

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

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

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

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

Study Arms (2)

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

EXPERIMENTAL

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).

Behavioral: Beat-accentuated, personalized music stimulation (BMS); Behavioral: Strength Training (ST); Behavioral: Aerobic exercise (AE)

Exercise intervention without BMS

ACTIVE COMPARATOR

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).

Behavioral: Strength Training (ST); Behavioral: Aerobic exercise (AE)

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.

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

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.

Exercise intervention with beat-accentuated, personalized music stimulation (BMS); Exercise intervention without BMS

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.

Exercise intervention with beat-accentuated, personalized music stimulation (BMS); Exercise intervention without BMS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Alzheimer's Association: collaborator
• University of North Carolina, Greensboro: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30324, United States

RECRUITING

UNC Greensboro

Greensboro, North Carolina, 27412, United States

COMPLETED

Related Publications (1)

• 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.

  PMID: 36760458 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kyoung Shin Park, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

404-727-8919; istep@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 11, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)