Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients

NCT ID: NCT05537467

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2027-12-31

Brief Summary

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The study aims to assess the effect of music on the heart resulting in a change in their exercise capacity among systolic heart failure patients undergoing Cardiopulmonary Exercise testing.

Detailed Description

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Studies have previously shown the positive impact of music on the autonomic nervous system, neurohormonal and cardiovascular system. In addition, a previously published study found a positive impact of music resulting in an improvement of quality of life (QOL) in heart failure patients. Proposed mechanisms of benefit of music in heart failure include a reduction in sympathetic activity, and modulation of parasympathetic activity. Further, reduction in anxiety and arterial relaxation are thought to be beneficial effects of music. It is hypothesized that heart failure patients listening to music would have better exercise stress test performance and increased exercise time.

Adult patients with systolic heart failure scheduled to undergo Cardiopulmonary Exercise (CPX) testing at the Gill Heart and Vascular Institute will be recruited.

While the patients are undergoing Cardiopulmonary exercise testing, patients randomized to the 'music arm' will listen to pre-selected upbeat music during their duration of the exercise testing via headphones that will be provided to patients by the study personnel. The patients who are randomized to 'non-music arm' in which their headphones will not play music and the patients will perform the cardiopulmonary exercise testing as usual.

Standard clinical care is performing cardiopulmonary exercise testing without any music.

The investigators will then compare the results of CPX study of the two arms to assess the impact of music on exercise performance.

Conditions

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Heart Failure

Keywords

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Cardiopulmonary stress test Exercise stress test Cardiology Exercise performance Heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Music

Music arm will listen to pre-selected music during their duration of the exercise testing via headphones that will be provided to the patients by the study personnel.

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Patients randomized to the music group will listen to upbeat music using headphones.

Non-music

Non-music arm will not have pre-selected music playing during their duration of the exercise testing via the headphones provided to the patients by the study personnel.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

Patients randomized to the music group will listen to upbeat music using headphones.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults (age \>18 years)
* Able to consent
* English speaking

Exclusion Criteria

* Severe hearing deficiency
* Unable to exercise.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maya Ignaszewski

OTHER

Sponsor Role lead

Responsible Party

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Maya Ignaszewski

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Maya T Ignaszewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Peggy J Hardesty, APRN, MSN

Role: CONTACT

Phone: 859-323-0295

Email: [email protected]

Jennifer R Isaacs, MS, MS

Role: CONTACT

Phone: 859-323-4738

Email: [email protected]

Facility Contacts

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Peggy J Hardesty, APRN, MSN

Role: primary

Jennifer R Isaacs, MS, MS

Role: backup

Maya T Ignaszewski, MD

Role: backup

Other Identifiers

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76503

Identifier Type: -

Identifier Source: org_study_id