Recruiting

Music

Sponsor:

Maya Ignaszewski

Code:

NCT05537467

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Music

Study Details

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.

Conditions

Heart Failure

Study ID

NCT05537467

Start date

Sep 13, 2022

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe hearing deficiency
  • Unable to exercise.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

Music

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

Primary outcome measure

  • Difference in O2 consumption (VO2) [L/min] [ Time Frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths) ]
  • Difference in CO2 production (VCO2) [L/min] [ Time Frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths) ]
  • Difference in respiratory exchange ratio (RER) [ Time Frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths) ]
  • Difference in Minute Ventilation (VE) [L/min] [ Time Frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths) ]
  • Difference in Ventilatory Threshold (VT) [L] [ Time Frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths) ]
  • Difference in respiratory rate (RR) [Breaths per minute] [ Time Frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths) ]
  • Difference in Ventilatory Equivalent of CO2 (VE/VCO2) [ Time Frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths) ]

Central Contacts and Locations

Central contacts

Peggy J Hardesty, APRN, MSN

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

Jennifer R Isaacs, MS, MS

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

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Peggy J Hardesty, APRN, MSN

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

Jennifer R Isaacs, MS, MS

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

Principal Investigator:

Maya T Ignaszewski, MD

More Information

Sponsor

Maya Ignaszewski

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Cardiopulmonary stress test
  • Exercise stress test
  • Cardiology
  • Exercise performance
  • Heart failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maya Ignaszewski on 2026-01-08.