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Rhythmically Enhanced Music Exercise Program for COPD

Phase 3
Waitlist Available
Led By Franco Laghi, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
COPD patients: FEV1 =< 70%
COVID19 patients: Previous hospital and/or emergency room visit for laboratory-confirmed COVID-19 diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is testing a home-based exercise program for Veterans with COPD, to see if it is more effective than current hospital-based rehab.

Who is the study for?
This trial is for COPD patients under 40 with specific lung function criteria and COVID-19 survivors over 18 who were hospitalized. Participants must be able to walk independently, hear music, and have a certain oxygen level during exercise. Excluded are those with severe heart failure, recent exercise programs, or other conditions that limit exercise.Check my eligibility
What is being tested?
The study tests a home-based exercise program using rhythmically enhanced music (RAS) against usual care in improving physical activity for COPD patients and COVID-19 survivors. The goal is to see if this method can maintain rehab benefits longer than hospital-based programs.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include typical risks associated with physical exertion such as increased breathlessness or fatigue in COPD patients or post-COVID individuals engaging in the new exercise regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function is less than 70% of the expected.
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I was hospitalized or visited the ER for COVID-19.
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I am 40 years old or younger with COPD.
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My oxygen level stays around 88% when I exercise.
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I am 18 years old or older and have COVID-19.
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I can walk by myself despite having COVID-19.
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My oxygen level drops to 88% or lower when I exercise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
six-minute walk distance
volume of daily physical activity
Other outcome measures
responsiveness to rehabilitation (exercise duration on the constant-load treadmill test)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RAS-music groupExperimental Treatment1 Intervention
Home-based, exercise program augmented with rhythmically auditory stimulation enhanced music
Group II: Control groupActive Control1 Intervention
Home-based, exercise program without rhythmically auditory stimulation enhanced music

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,432 Total Patients Enrolled
Franco Laghi, MDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
1 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Rhythmically Enhanced Music Clinical Trial Eligibility Overview. Trial Name: NCT03655028 — Phase 3
Rhythmically Enhanced Music 2023 Treatment Timeline for Medical Study. Trial Name: NCT03655028 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: RAS-music group, Control group
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Rhythmically Enhanced Music Highlights & Side Effects. Trial Name: NCT03655028 — Phase 3

Frequently Asked Questions

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

How many people are currently enrolled in this clinical trial?

"That is correct. Currently, the clinical trial is recruiting patients. The listing was first created on October 1st, 2018 and updated February 18th, 2022. They are looking for a total of 170 individuals from 1 site."

Answered by AI

What are the risks associated with using rhythmically auditory stimulation enhanced music for patients?

"There is some evidence from earlier trials to support the efficacy of rhythmically auditory stimulation enhanced music, and it has been through multiple rounds of testing to ensure safety. This gave it a score of 3 on our Power team's scale."

Answered by AI

Are new participants being accepted into this clinical trial?

"This trial, which was created on October 1st 2018 and last updated February 18th 2022, is still recruiting patients according to the clinicaltrials.gov website."

Answered by AI

Who else is applying?

What site did they apply to?
Edward Hines Jr. VA Hospital, Hines, IL
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
2018. "Increasing Physical Activity in COPD Through Rhythmically Enhanced Music". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03655028.
All > Copd
~26 spots leftby Apr 2025
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