N/A N=65 Randomized Triple-blind Treatment

Singing and Cardiovascular Health in Older Adults

Cardiovascular Diseases · Cardiovascular Risk Factor · Cardiovascular Health

Bottom Line

View on ClinicalTrials.gov: NCT04121741 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Change in FMD% — -0.06; -0.11; -0.06 FMD percent — p=0.864

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Singing with Music Therapist (Other); Singing with Guided Video (Other); Control Arm (Other)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in FMD%	-0.06; -0.11; -0.06	0.864
PRIMARY Change in Reactive Hyperemia Index (RHI)	0.22; 0.19; 0.12	0.290
PRIMARY Change in Framingham Reactive Hyperemia Index (fRHI)	0.8; 0.6; 0.6	0.005 sig
SECONDARY BORG Rating of Perceived Exertion	9.98; 10.66; 6.33	—
SECONDARY Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)	20.7; 22.4; 29.5; 14.5; 23.0; 9.2	—
SECONDARY Change in RMSSD (Root Mean Square of Successive Differences)	56.9; 49.5; 62.6; 52.5; 80.2; 40.6	—
SECONDARY Change in HF Power (High-frequency Power)	477.5; -334.7; 401.0; 242.7; -141.3; 423.7	—
SECONDARY Change in LF Power (Low-frequency Power)	1318.8; 636.2; 244.8; 525.3; 254.1; -19.7	—
SECONDARY Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)	0.6; 0.3; -1.0; 2.2; -0.2; -0.6	—
SECONDARY Change in LnHF Power (Natural Log (Milliseconds Squared))	0.1; -0.2; 0.3; -0.1; -0.0; 0.3	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04121741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.