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NCT07881692
GOT VOICE Feasibility With In-Person Group Singing
Conditions: Elderly, Coronary Arterial Disease (CAD)
Sex: All
Ages: 55 Years – 89 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Medical College of Wisconsin
Location: Medical College of Wisconsin Milwaukee Wisconsin
Summary
Unlike traditional physical exercise, the impact of singing on cardiovascular health has not been extensively studied. Endothelial dysfunction predicts cardiovascular events, and physical exercise improves vascular endothelial function. In a rigorously conducted randomized, cross-over control study, this study team is the first to demonstrate that 30 minutes of solo singing improves endothelial function acutely, regardless of singing expertise. Changes were more robust in subjects with baseline endothelial dysfunction (i.e., those with established coronary artery disease). The improvements occurred in microvascular, but not macrovascular, endothelial function. The observed change in microvascular function translates into a \~25% reduction in cardiovascular disease (CVD) risk, which is comparable to traditional cardiac rehabilitation program participation.
Based on the investigator's prior research, the overall objective of the planned future RCT is to test the central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering CVD risk. The overall objective of this project, titled "GrOup singing or solo singing To improve Vascular health in Older adults wIth Coronary artery disEase (GOT VOICE): A Feasibility Study", is to refine and protocolize the singing interventions and test the feasibility of future trial design.
Eligibility Criteria
Inclusion Criteria:
* Subjects ≥55 up to 89 years old
* Known history of stable coronary artery disease (over 1 year out from a coronary stent, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting)
Exclusion Criteria:
* Parkinson's disease or tremor, upper arm fistula, or fingernail onychomycosis (all impact assessment of vascular function at the fingertips), pregnancy, current tobacco use, current illicit drug use, current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men), more than mild cognitive impairment (as documented in the medical record by patient's treatment teams) or inability to follow study procedures, and non-English speaking.
* Baseline hearing will be assessed with a tablet-based tool. Those with severe hearing loss will be ineligible.
* Participants cannot currently be enrolled in a traditional or intensive cardiac rehabilitation program.
* Individuals with unstable cardiovascular conditions (e.g., uncontrolled arrhythmias, unstable angina, decompensated heart failure, or uncontrolled hypertension) will be excluded from participation.
* Participants with severe or unstable respiratory disease, acute respiratory infections, or conditions that would limit safe participation in singing exercises will be excluded or discussed with their pulmonologist. For participants with stable chronic respiratory conditions, participation will be permitted provided symptoms are well managed and do not interfere with the ability to engage safely in the intervention. We made this decision because there is a substantial body of literature examining singing interventions in individuals with COPD, often under the title "Singing for Lung Health (SLH)." These studies generally report that singing is safe for people with stable COPD and may improve quality of life, breathing control, respiratory muscle function, and exercise tolerance.
* Life expectancy is less than 2 years
* Active malignancy
Source: ClinicalTrials.gov (NCT07881692). StuddyBuddy aggregates publicly available trial information.