Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients (MUSIC-CPX)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Music

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer R Isaacs, MS, MS; Phone Number: 859-323-4738; Email: jennifer.isaacs@uky.edu
• Study Contact Backup: Name: Peggy J Hardesty, APRN, MSN; Phone Number: 859-323-0295; Email: peggy.hardesty@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Contact: Jennifer R Isaacs, MS, MS; Phone Number: 859-323-4738; Email: jennifer.isaacs@uky.edu
      • Contact: Peggy J Hardesty, APRN, MSN; Phone Number: 859-323-0295; Email: peggy.hardesty@uky.edu
      • Principal Investigator: Maya T Ignaszewski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe hearing deficiency
• Unable to exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Music; Patients randomized to the music group will listen to upbeat music using headphones.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Heart Rate [Beats 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 O2 Pulse [ml]	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 Systolic and Diastolic Blood Pressure [mmHg]	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 Exercise time [mm:ss]	Compare the CPX parameter between Music and Non-Music Arm	15 minutes (Start to end of CPX study)
Difference in Work rate [watt]	Compare the CPX parameter between Music and Non-Music Arm	15 minutes (Start to end of each CPX study)

Collaborators and Investigators

• Sponsor: Maya Ignaszewski
• Investigators: Principal Investigator: Maya T Ignaszewski, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Heart failure; Cardiology; Exercise performance; Exercise stress test; Cardiopulmonary stress test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Music Therapy
• Other Study ID Numbers: 76503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No