Singing and Cardiovascular Health in Older Adults

Not Applicable

Completed

Conditions: Cardiovascular Health
Cardiovascular Diseases
Cardiovascular Risk Factor

Interventions: Other: Control Arm
Other: Singing with Guided Video
Other: Singing with Music Therapist

Registration Number: NCT04121741

Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control/sham intervention	Control Arm	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.
Singing intervention 1	Singing with Guided Video	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.
Singing intervention 2	Singing with Music Therapist	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.

Primary Outcome Measures

Name	Time	Method
Change in FMD%	At baseline and after 30-minute singing and control intervention(s)	Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.
Change in Reactive Hyperemia Index (RHI)	At baseline and after 30-minute singing and control intervention(s)	Assess microvascular endothelial function by measuring changes in reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in RHI is considered a better outcome.
Change in Framingham Reactive Hyperemia Index (fRHI)	At baseline and after 30-minute singing and control intervention(s)	Assess microvascular endothelial function by measuring changes in Framingham reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in fRHI is considered a better outcome.

Secondary Outcome Measures

Name	Time	Method
BORG Rating of Perceived Exertion	after 30-minute singing (and sham) interventions	The BORG RPE scale assesses an individual's perceived level of exertion. It ranges from 6 to 20, whereas 6 reflects no exertion at all and 20 reflects maximal exertion.
Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)	at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)	Heart rate variability is assessed using SDNN (Standard Deviation of Normal-to-Normal intervals) before, during, and post-intervention. Reported as percent change compared to the baseline (pre) value. Percent change calculated as 100\\[(post-pre)/pre\] or 100\\[(during-pre)/pre\]. An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Change in RMSSD (Root Mean Square of Successive Differences)	at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)	Heart rate variability is assessed using (RMSSD) root mean square of successive differences before, during, and post-intervention. Reported as percent change compared to the baseline (pre) value. Percent change calculated as 100\\[(post-pre)/pre\] or 100\\[(during-pre)/pre\]. An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Change in HF Power (High-frequency Power)	at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)	Heart rate variability is assessed using high-frequency power (HF Power) before, during and post-intervention. Reported as an absolute change or difference compared to baseline (pre). Unit of measurement is milliseconds-squared. Power in the High Frequency band of the HRV spectrum falls between 0.15-0.40 Hz. The actual activity in that band is typically expressed in terms of "power", which uses the units of milliseconds-squared for a particular Hertz (Hz) band. Think of it as an "area under the curve". An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Change in LF Power (Low-frequency Power)	at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)	Heart rate variability is assessed using low-frequency power (LF Power) before, during and post-intervention. Reported as an absolute change or difference compared to baseline (pre). Unit of measurement is milliseconds-squared. Power in the Low Frequency band of the HRV spectrum is defined as greater than 0.00 Hz and less than 0.04 Hz. The actual activity in that band is typically expressed in terms of "power", which uses the units of milliseconds-squared for a particular Hertz (Hz) band. Think of it as an "area under the curve". An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)	at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)	Heart rate variability is assessed using LF/HF ratio before, during and post-intervention. This is an (absolute) difference between ratios, so there are no units of measure. The LF/HF ratio is as an index of sympatho-vagal balance between the sympathetic and parasympathetic nervous systems. An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Change in LnHF Power (Natural Log (Milliseconds Squared))	at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)	Heart rate variability is assessed using LnHF Power before, during and post-intervention. The physiological range for the LnHF Power in heart rate variability is typically considered to be between 4 and 7. Reported here as an absolute change or difference in LnHF Power (natural log (milliseconds squared)). Under controlled conditions while breathing at normal rates, we can use LnHF Power to estimate vagal tone. Interpreting results: Higher natural log HF power: Indicates greater parasympathetic activity, often associated with relaxation and a healthy stress response. Lower natural log HF power: May suggest decreased parasympathetic activity, potentially related to stress or other physiological factors. An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).