Clinical trial NCT05537467: Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
Official title: Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Cardiopulmonary stress test
Exercise stress test
Cardiology
Exercise performance
Heart failure
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Severe hearing deficiency
* Unable to exercise.

Primary outcomes:
measure: Difference in O2 consumption (VO2) [L/min]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in CO2 production (VCO2) [L/min]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in respiratory exchange ratio (RER)
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in Minute Ventilation (VE) [L/min]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in Ventilatory Threshold (VT) [L]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in respiratory rate (RR) [Breaths per minute]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in Ventilatory Equivalent of CO2 (VE/VCO2)
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Secondary outcomes:
measure: Difference in Heart Rate [Beats per minute]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in O2 Pulse [ml]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in Systolic and Diastolic Blood Pressure [mmHg]
timeFrame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
measure: Difference in Exercise time [mm:ss]
timeFrame: 15 minutes (Start to end of CPX study)
measure: Difference in Work rate [watt]
timeFrame: 15 minutes (Start to end of each CPX study)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Maya T Ignaszewski, MD
role: PRINCIPAL_INVESTIGATOR
References: