Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Music
Patients randomized to the music group will listen to upbeat music using headphones.
Primary outcome measures
- 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)]
Secondary outcome measures (5)
- Difference in Heart Rate [Beats per minute] [Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in O2 Pulse [ml] [Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in Systolic and Diastolic Blood Pressure [mmHg] [Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)]
- Difference in Exercise time [mm:ss] [Time frame: 15 minutes (Start to end of CPX study)]
- Difference in Work rate [watt] [Time frame: 15 minutes (Start to end of each CPX study)]
Eligibility criteria
Inclusion criteria
- Adults (age >18 years)
- Able to consent
- English speaking
Exclusion criteria
- Severe hearing deficiency
- Unable to exercise.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT05537467 · 76503