Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients

Study Overview
=================
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.

Official Title
-----------------
Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age >18 years) Able to consent English speaking Exclusion Criteria: Severe hearing deficiency Unable to exercise.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>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<br>* Patients randomized to the music group will listen to upbeat music using headphones.<br>|
| No Intervention: Non-music<br>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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary stress test, Exercise stress test, Cardiology, Exercise performance, Heart failure