Singing and Cardiovascular Health in Older Adults

Medical College of Wisconsin

Status: Completed

Conditions: Cardiovascular Health; Cardiovascular Diseases; Cardiovascular Risk Factor

Treatments: Other: Singing with Guided Video; Other: Singing with Music Therapist; Other: Control Arm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04121741

35864

R33AT010680 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This proposal seeks to create, optimize and test two different singing interventions in older patients with CVD. The study will consist of three arms, according to a randomized, single-blind, crossover, sham procedure-controlled design. Sixty-five total participants will each have three visits on three different occasions for the following interventions:

1. a 30-minute period of guided singing from an in-person music therapist
2. a 30-minute period of singing along to an instructional video including a professor of voice and "inexperienced, older singing student"
3. a 30-minute sham intervention (subjects will undergo a hearing test)

The goal will be to determine which singing intervention, if any, is superior to the other - as this would be important to guide longer and larger clinical trials in the field. Knowledge gained from this proposal will improve understanding of biologic mechanisms of singing behaviors, as it relates to CVD.

Enrollment: 65 patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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65 participants in 3 patient groups

Singing intervention 1

Active Comparator group

Description:

Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing.

Treatment:

Other: Singing with Guided Video

Singing intervention 2

Active Comparator group

Description:

In-person music therapy session. The music therapist will continue to coach throughout the 30-minute session. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing.

Treatment:

Other: Singing with Music Therapist

Control/sham intervention

Sham Comparator group

Description:

Subjects will have a 30-minute period of rest sitting upright (as they would be positioned for the singing interventions). This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after the 30 minute rest.

Treatment:

Other: Control Arm