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Behavioural Intervention

Exercise and music stimulation for Cognitively Normal Older Adults (iSTEP Trial)

N/A

Recruiting

Led By Jennifer L Etnier, PhD

Research Sponsored by University of North Carolina, Greensboro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be reported daily from the first day of the intervention to the last day of the intervention (6 months)

Awards & highlights

iSTEP Trial Summary

This trial aims to see if listening to music with a beat can help older adults become more active. The study will look at whether this type of music can positively affect their physical activity levels and how they

Who is the study for?

This trial is for cognitively normal older adults who are interested in improving their physical activity. Participants will engage in supervised group strength and aerobic exercises, with some sessions incorporating beat-accented music stimulation (BMS).Check my eligibility

What is being tested?

The study aims to see if BMS can positively affect exercise behavior and psychological responses over a 6-month period. It also looks at how exercising with BMS might impact physical and cognitive functions, as well as quality of life.See study design

What are the potential side effects?

Since the interventions involve music and exercise, side effects may include typical exercise-related issues such as muscle soreness or strain. No significant side effects from listening to music are expected.

iSTEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be reported daily from the first day of the intervention to the last day of the intervention (6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be reported daily from the first day of the intervention to the last day of the intervention (6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be reported daily from the first day of the intervention to the last day of the intervention (6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ecological Momentary Assessment (EMA): Affective response to PA

Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect

Ecological Momentary Assessment (EMA): Behavioral intention

+6 more

Secondary outcome measures

10-Meter Walk

30-second Chair Stand

4-Stage Balance Test

+20 more

iSTEP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise and music stimulationExperimental Treatment2 Interventions

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.

Group II: Exercise onlyActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~760

Music

2013

Completed Phase 3

~1810

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,835 Total Patients Enrolled

3 Trials studying Cognitively Normal Older Adults

853 Patients Enrolled for Cognitively Normal Older Adults

University of North Carolina, GreensboroLead Sponsor

31 Previous Clinical Trials

16,591 Total Patients Enrolled

Jennifer L Etnier, PhDPrincipal InvestigatorUniversity of North Carolina, Greensboro

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients currently being enrolled in this ongoing clinical trial?

"Indeed, details on clinicaltrials.gov indicate that this trial is actively enrolling participants. The trial was first posted on April 15th, 2024 and last updated on April 12th, 2024. It aims to recruit a total of 50 individuals from one specific location."

Answered by AI

What is the upper threshold for the number of individuals enrolled in this medical study?

"Indeed, information available on clinicaltrials.gov affirms that this investigation is currently in search of suitable participants. The trial was initially made public on April 15th, 2024 and underwent its most recent update on April 12th, 2024. To complete the study successfully, they aim to recruit a total of 50 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inspiring Seniors Toward Exercise Promotion

Jennifer L. Etnier 2024. "Inspiring Seniors Toward Exercise Promotion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06364189.

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