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Behavioural Intervention

Music for Alzheimer's Disease Prevention (iSTEP+ Trial)

N/A

Recruiting

Led By Kyoung Shin Park, 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

Adults at least 65 years old

Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane

Must not have

Stroke or neural impairment in the past 6 months

Diagnosis of neurological disorder or spinal cord disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if listening to beat-accented music while exercising can help older adults with memory complaints to be more physically active. Participants will be divided into two groups - one group will exercise

Who is the study for?

This trial is for older adults with memory complaints who are able to participate in regular physical activity. They should be willing to exercise with or without beat-accented music as part of the study and commit to a structured exercise program for 6 months.

What is being tested?

The trial is testing if exercising while listening to beat-accented music can improve physical activity, cognitive function, and quality of life in seniors. Participants will do strength training and aerobic exercises either with or without music.

What are the potential side effects?

Since this intervention involves common physical activities like strength training and aerobic exercises, potential side effects may include typical exercise-related issues such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I can walk for 6 minutes without help or pain.

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I do not have thoughts of suicide and am not diagnosed with depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a stroke or brain injury in the last 6 months.

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I have been diagnosed with a neurological or spinal cord disorder.

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I cannot or do not want to attend the required classes 3 times a week initially, then once a week.

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I have been diagnosed with clinical depression.

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I have hearing or vision problems that haven't been corrected.

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I have not had a hip, knee, or spinal fracture or surgery in the last 6 months.

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I understand the study procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to the physical activity program

Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale

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

Secondary study objectives

Episodic memory as assessed using the Mnemonic Similarity Task

Episodic memory as assessed using the NIH Toolbox Picture Sequence Memory test

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

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise and musicExperimental Treatment1 Intervention

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.

Group II: ExerciseActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Music

2013

Completed Phase 3

~1810

0 / 10Eligibility criteria met