Music for Heart Failure

(MUSIC-CPX Trial)

Overseen By Jennifer R Isaacs, MS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Peggy J Hardesty

Disqualifiers: Severe hearing deficiency, unable to exercise

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 15 minutes

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music therapy might help people with systolic heart failure improve their exercise ability. Participants will be divided into two groups: one will listen to pre-selected music during exercise tests, while the other will not. The goal is to determine if music can boost exercise performance in people with heart failure. It suits English-speaking adults who can exercise and do not have severe hearing issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance exercise performance for heart failure patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that music therapy is safe for heart failure patients?

Research shows that music therapy is generally safe for everyone, including those with heart problems. Studies have found that listening to music can lower heart rate and blood pressure, both positive indicators for heart health. It also helps reduce anxiety and pain, making patients more comfortable during medical procedures.

In one study, patients who listened to music experienced lower heart rates and blood pressure. Another study found that music therapy improved patient experiences in heart care by reducing stress and the need for medication to help them relax.

Overall, music therapy appears well-tolerated, with no serious side effects reported. This suggests it is a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using music as a treatment for heart failure because it offers a non-invasive and drug-free approach to improving patient outcomes. Unlike typical treatments such as medications and lifestyle changes, listening to music during exercise could enhance mood and motivation, making it easier for patients to stick with their exercise routines. This approach leverages the natural, therapeutic effects of music, potentially providing benefits without the side effects often associated with pharmaceuticals.

What evidence suggests that music therapy is effective for heart failure?

Research shows that music can benefit heart health. Studies have found that listening to music can lower heart rate and blood pressure, which is important for people with heart failure. One study discovered that music therapy reduced arterial pressure during heartbeats by an average of 6.58 mmHg. Other research suggests that music can improve the quality of life for heart failure patients by reducing stress and anxiety. In this trial, participants in the music arm will listen to pre-selected music during exercise testing, while those in the non-music arm will not have music playing. Overall, music therapy appears to be a safe and helpful way to support heart health and improve exercise ability in heart failure patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Maya T Ignaszewski, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with systolic heart failure who can consent to participate. It's not suitable for those with severe hearing issues or an inability to exercise.

Inclusion Criteria

I am over 18 years old.

Able to consent

English speaking

Exclusion Criteria

You cannot do physical activity.

I have a severe hearing problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Cardiopulmonary Exercise (CPX) testing with or without music

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Music

Trial Overview

The study is testing the impact of music on exercise capacity in heart failure patients during Cardiopulmonary Exercise tests, aiming to see if it improves their heart function and ability to exercise.

How Is the Trial Designed?

Group I: Music Experimental Treatment 1 Intervention

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.

Group II: Non-music Active Control 1 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 Is Running the Clinical Trial?

Peggy J Hardesty

Lead Sponsor

Trials

1

Recruited

40+

Maya Ignaszewski

Lead Sponsor

Trials

1

Recruited

40+

Gaurang Vaidya

Lead Sponsor

Trials

2

Recruited

220+

Published Research Related to This Trial

A meta-analysis of 183 studies across 11 medical specialties found that music therapy interventions have significantly greater positive effects on outcomes like pain, well-being, mood, and nausea/vomiting compared to music medicine interventions.

The analysis particularly highlighted benefits for patients with cancer, those who are terminally ill, and patients with HIV, indicating that music therapy can be an effective complementary treatment in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music and music therapy on medical patients: a meta-analysis of the research and implications for the future. Dileo, C.[2022]

Music therapy is safe and effective for reducing stress in patients in coronary care units, helping to manage their psychophysiological stress responses.

Age and gender may affect how the autonomic nervous system responds to cardiovascular stress, indicating that older adults should learn techniques to manage blood pressure changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variables influencing cardiovascular function. Fitzsimmons, L., Shively, M., Verderber, A.[2019]

This study is a multicenter randomized controlled trial involving 150 heart failure patients, aiming to assess the effectiveness of a specific recorded music-listening protocol on improving quality of life and reducing symptom burden over a 3-month period.

If successful, the findings could establish recorded music listening as a beneficial intervention for heart failure patients, potentially enhancing their overall well-being alongside standard medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Listening to Recorded Music for Heart Failure Patients: Study Protocol. Burrai, F., Hasan, W., Fancourt, D., et al.[2016]

Drug therapy for heart failure can significantly improve symptoms and quality of life, especially in patients with severe heart failure, while also aiming to reduce the risk of serious events like ventricular arrhythmias and extend survival.

The effectiveness of heart failure treatments varies by the stage of the disease; early treatment may lead to better survival rates, while advanced stages focus more on symptom relief and quality of life rather than survival extension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic targets and expectations for the treatment of heart failure. Taylor, SH.[2019]

Music therapy has been effectively used in cardiac care for patients with conditions like acute myocardial infarction and coronary artery bypass graft, helping them cope with stress during recovery.

The article reviews research and provides case examples, demonstrating various clinical methods that music therapists use to support patients' emotional and psychological well-being in cardiac settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of music therapy in cardiac healthcare. Hanser, SB., Mandel, SE.[2008]

In a randomized clinical trial involving breast cancer patients undergoing chemotherapy, a 30-minute music intervention before treatment significantly improved quality of life scores compared to a control group.

The music group also experienced lower levels of depression and anxiety, as well as reduced incidence of vomiting during chemotherapy, indicating that music can be an effective complementary therapy to alleviate some adverse effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. Lima, TU., Moura, ECR., Oliveira, CMB., et al.[2021]

In a multicenter randomized controlled trial involving 159 heart failure patients, listening to recorded classical music for at least 30 minutes a day over 3 months significantly improved heart failure-specific quality of life, generic quality of life, sleep quality, and reduced anxiety and depression levels.

This noninvasive and safe intervention demonstrates that classical music can be an effective complementary treatment to enhance the overall well-being of heart failure patients in a home-care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Listening to Classical Music in Patients With Heart Failure: A Randomized Controlled Trial. Burrai, F., Sanna, GD., Moccia, E., et al.[2021]

A review of 29 studies involving 2579 patients found that receptive music intervention did not lead to significant changes in cardiovascular measures like heart rate and blood pressure, particularly in higher quality studies with 1054 patients.

Due to the high variability in study methods and quality, no definitive conclusions can be drawn about the effectiveness of music as a therapeutic intervention for cardiovascular health, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of music on patients with cardiovascular diseases and during cardiovascular interventions : A systematic review. Ho, CY., Wexberg, P., Schneider, B., et al.[2021]

In a study involving 105 hospitalized heart failure patients, both Benson muscle relaxation and nature sounds significantly reduced fatigue compared to a control group, highlighting their potential as effective interventions.

There was no significant difference in fatigue reduction between the two methods, suggesting that both are viable, low-cost alternatives that can be easily integrated into routine nursing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effects of Benson Muscle Relaxation and Nature Sounds on the Fatigue in Patients With Heart Failure: A Randomized Controlled Clinical Trial. Seifi, L., Najafi Ghezeljeh, T., Haghani, H.[2018]

Music listening protocols may offer a novel approach to improving cardiovascular health in patients with heart failure, potentially enhancing their overall treatment alongside traditional methods.

The proposed framework suggests that music can positively influence heart health through complex interactions involving psychological, neurological, immune, and endocrine systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Conceptual Framework Encompassing the Psychoneuroimmunoendocrinological Influences of Listening to Music in Patients With Heart Failure. Burrai, F., Hasan, W., Luppi, M., et al.[2018]

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