Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients

Heart Failure Clinical Trial

— MUSIC-CPX  

Official title:

Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05537467
• Other study ID #: 76503
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Kentucky
• Contact: Peggy J Hardesty, APRN, MSN
• Phone: 859-323-0295
• Email: peggy.hardesty[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (age >18 years)

• Able to consent

• English speaking

Exclusion Criteria:

• Severe hearing deficiency

• Unable to exercise.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Music
Patients randomized to the music group will listen to upbeat music using headphones.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Maya Ignaszewski

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Difference in Exercise time [mm:ss]	Compare the CPX parameter between Music and Non-Music Arm	15 minutes (Start to end of CPX study)
Secondary	Difference in Work rate [watt]	Compare the CPX parameter between Music and Non-Music Arm	15 minutes (Start to end of each CPX study)