Inspiring Seniors Towards Exercise Promotion to Protect Cognition (iSTEP+)

Emory University

Status: Enrolling

Conditions: Alzheimer Disease; Physical Activity

Treatments: Behavioral: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT06496425

STUDY00008531

AARF-23-1145107 (Other Grant/Funding Number)

Details and patient eligibility

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. 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 min/day) and and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/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 >150min/week AE and 3 days/week of ST for 30 min/day).

Enrollment: 80 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults at least 65 years old.
• Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane.
• 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 (6 months).
• Having a reliable means of transportation.
• Having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training.
• Having self-perceived memory complaints.
• Having no symptoms of suicidal ideation and not meeting criteria for depressive disorder.
• Physically low-active by doing < 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months.

Exclusion criteria

• Diagnosis of neurological disorder or spinal cord disorder.
• Known exercise contraindications.
• Current cancer treatment.
• Stroke or neural impairment in the past 6 months.
• Hip/knee/spinal fracture or surgery in the past 6 month.
• Unable or unwilling to attend intervention classes 3x/week in Months 1-2 and 1x/week in Months 3-4.
• Currently participating in any other physical activity or fitness-related research study.
• Use of medication for Alzheimer's disease. Change in dosage of medications prescribed for anxiety or depression within the previous 6 months.
• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Exercise and music

Experimental group

Description:

The strength training (ST) program incorporates single-leg exercises for balance training and training with resistance bands and body weight. During the ST, participants will be asked to synchronize their concentric and eccentric muscle contractions in time with the tempo of BMS playlists at a specific music tempo. For aerobic exercise (AE), participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week. Participants will be trained to walk in synchrony with the beats. Participants will receive individualized music playlists to match individual walking cadence and music preference.

Treatment:

Behavioral: Music

Exercise

No Intervention group

Description:

The ST program incorporates single-leg exercises for balance training and training with resistance bands and body weight. For AE, participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week.