Singing and Cardiovascular Health in Older Adults (NCT04121741) | Clinical Trial Compass
CompletedNot Applicable
Singing and Cardiovascular Health in Older Adults
United States65 participantsStarted 2020-01-17
Plain-language summary
Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Older adults are less likely to participate in CR, as comorbidities in this population, including arthritis and chronic obstructive pulmonary disease, make participation difficult. Singing is a physical activity that involves components of the vagal nerves manifested as changes in cardiac autonomic regulation. Unlike physical exercise, the effects of singing on cardiovascular health has not been well-studied. The hypothesis for this project is that older patients with CVD will have favorable improvement in cardiovascular biomarkers, including, endothelial function and heart rate variability (HRV), after 30 minutes of singing.
Who can participate
Age range
55 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* English Speaking
* Have a history of coronary artery disease (defined as history of myocardial infarction, coronary stenosis \>50%, percutaneous coronary intervention with stent placement, balloon angioplasty, or coronary arterial bypass grafting)
Exclusion Criteria:
* Subjects with a permanent pacemaker or implantable cardioverter defibrillator (ICD) implanted
* Patients with a history of atrial fibrillation, flutter or atrial tachycardia
* Parkinson's disease or a tremor
* Amputated upper extremity or presence of upper-arm (dialysis) fistula
* Fingernail onychomycosis (fungal infections resulting in thickening of the nails)
* Pregnancy
* Current illicit drug use (marijuana, tobacco, cocaine, amphetamines, etc.)
* Current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
* Unstable coronary heart disease (active symptoms of chest discomfort)
* History of a Stroke or TIA or peripheral arterial disease
* Known history of cognitive impairment or inability to follow study procedures
* Cancer requiring systemic treatment within five years of enrollment.
* Subjects requiring supplemental oxygen use
* Non-English speaking subjects (video with lyrics are taped in English)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in FMD%
Timeframe: At baseline and after 30-minute singing and control intervention(s)
2
Change in Reactive Hyperemia Index (RHI)
Timeframe: At baseline and after 30-minute singing and control intervention(s)
3
Change in Framingham Reactive Hyperemia Index (fRHI)
Timeframe: At baseline and after 30-minute singing and control intervention(s)