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Inspiring Seniors Toward Exercise Promotion (iSTEP)

U

University of North Carolina, Greensboro

Status

Completed

Conditions

Cognitively Normal Older Adults

Treatments

Behavioral: Music
Behavioral: Exercise

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06364189
FY22-119
R61AG084479 (U.S. NIH Grant/Contract)

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. 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 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

54 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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 no diagnosis or symptoms of cognitive impairment.
  • 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.
  • Having no diagnosis or symptoms of 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

54 participants in 2 patient groups

Exercise and music stimulation
Experimental group
Description:
Participants are given an aerobic and strength training program with faded supervision across 6 months. 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 of their personalized playlists. The strength training (ST) 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 beats-per-minute rhythm.
Treatment:
Behavioral: Exercise
Behavioral: Music
Exercise only
Active Comparator group
Description:
Participants are given an aerobic and strength training program with faded supervision across 6 months. The ST incorporates single-leg exercises for balance training and training with resistance bands and body weight. 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.
Treatment:
Behavioral: Exercise

Trial contacts and locations

2

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Central trial contact

Project Coordinator

Data sourced from clinicaltrials.gov

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