Heart FailureMUSIC-CPXNCT05537467
Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
A study testing Music in people with Heart Failure, run by Maya Ignaszewski at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age >18 years)
- Able to consent
- English speaking
Who cannot join
- Severe hearing deficiency
- Unable to exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Peggy J Hardesty, APRN, MSN, 859-323-0295, peggy.hardesty@uky.edu
Jennifer R Isaacs, MS, MS, 859-323-4738, jennifer.isaacs@uky.edu
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Music
- Keywords
- Cardiopulmonary stress test, Exercise stress test, Cardiology, Exercise performance, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Patients randomized to the music group will listen to upbeat music using headphones.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | 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. Receives: Other: Music |
| Non-music | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Difference in O2 consumption (VO2) [L/min]
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Secondary outcomes (5)
Difference in Heart Rate [Beats per minute]
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Measured: 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
Measured: 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
Measured: 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
Measured: 15 minutes (Start to end of CPX study)
Difference in Work rate [watt]
Compare the CPX parameter between Music and Non-Music Arm
Measured: 15 minutes (Start to end of each CPX study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start13 Sep 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maya Ignaszewski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maya Ignaszewski, University of Kentucky
- Investigators
- Maya T Ignaszewski, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537467
- Sponsor's protocol ID
- 76503
- Acronym
- MUSIC-CPX
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05537467
- Acronym / sponsor ID
- MUSIC-CPX / 76503
- Conditions
- Heart Failure
- Keywords
- Cardiopulmonary stress test, Exercise stress test, Cardiology, Exercise performance, Heart failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maya IgnaszewskiUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicMusic 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. |
| Non-music | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age >18 years)
- Able to consent
- English speaking
Key exclusion criteria (2 listed)
- Severe hearing deficiency
- Unable to exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicPatients randomized to the music group will listen to upbeat music using headphones. | Other | Music |
Primary outcome
Difference in O2 consumption (VO2) [L/min]
Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in CO2 production (VCO2) [L/min]
Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in respiratory exchange ratio (RER)
Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in Minute Ventilation (VE) [L/min]
Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in Ventilatory Threshold (VT) [L]
Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in respiratory rate (RR) [Breaths per minute]
Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in Ventilatory Equivalent of CO2 (VE/VCO2)
Time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya T Ignaszewski, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Heart Failure, run by Maya Ignaszewski at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peggy J Hardesty, APRN, MSN (859-323-0295, peggy.hardesty@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in O2 consumption (VO2) [L/min] (time frame: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.