NCT05537467

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
20mo left

Started Sep 2022

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Sep 2022Dec 2027

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

5.2 years

First QC Date

September 9, 2022

Last Update Submit

January 5, 2026

Conditions

Heart Failure

Keywords

Cardiopulmonary stress testExercise stress testCardiologyExercise performanceHeart failure

Outcome Measures

Primary Outcomes (7)

  • Difference in O2 consumption (VO2) [L/min]

    Assess above performance parameters in CPX and compare between Music and Non-Music arm.

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in CO2 production (VCO2) [L/min]

    Assess above performance parameters in CPX and compare between Music and Non-Music arm.

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in respiratory exchange ratio (RER)

    Assess above performance parameters in CPX and compare between Music and Non-Music arm.

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in Minute Ventilation (VE) [L/min]

    Assess above performance parameters in CPX and compare between Music and Non-Music arm

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in Ventilatory Threshold (VT) [L]

    Assess above performance parameters in CPX and compare between Music and Non-Music arm

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in respiratory rate (RR) [Breaths per minute]

    Assess above performance parameters in CPX and compare between Music and Non-Music arm

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in Ventilatory Equivalent of CO2 (VE/VCO2)

    Assess above performance parameters in CPX and compare between Music and Non-Music arm

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

Secondary Outcomes (5)

  • Difference in Heart Rate [Beats per minute]

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in O2 Pulse [ml]

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in Systolic and Diastolic Blood Pressure [mmHg]

    15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)

  • Difference in Exercise time [mm:ss]

    15 minutes (Start to end of CPX study)

  • Difference in Work rate [watt]

    15 minutes (Start to end of each CPX study)

Study Arms (2)

Music

EXPERIMENTAL

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.

Other: Music

Non-music

NO INTERVENTION

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.

Interventions

MusicOTHER

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

Music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe hearing deficiency
  • Unable to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maya T Ignaszewski, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peggy J Hardesty, APRN, MSN

CONTACT

859-323-0295peggy.hardesty@uky.edu

Jennifer R Isaacs, MS, MS

CONTACT

859-323-4738jennifer.isaacs@uky.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

September 13, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)