Clinical trial NCT04121741: Singing and Cardiovascular Health in Older Adults
Official title: Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Cardiovascular Health
Keywords: Singing
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-10-10
Enrollment: 65
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in FMD%
timeFrame: At baseline and after 30-minute singing and control intervention(s)
measure: Change in Reactive Hyperemia Index (RHI)
timeFrame: At baseline and after 30-minute singing and control intervention(s)
measure: Change in Framingham Reactive Hyperemia Index (fRHI)
timeFrame: At baseline and after 30-minute singing and control intervention(s)
Secondary outcomes:
measure: BORG Rating of Perceived Exertion
timeFrame: after 30-minute singing (and sham) interventions
measure: Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)
timeFrame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
measure: Change in RMSSD (Root Mean Square of Successive Differences)
timeFrame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
measure: Change in HF Power (High-frequency Power)
timeFrame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
measure: Change in LF Power (Low-frequency Power)
timeFrame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
measure: Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)
timeFrame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
measure: Change in LnHF Power (Natural Log (Milliseconds Squared))
timeFrame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Other outcomes:
measure: Change in TNF-alpha, IL-1 Beta, IL-6, and IL-8
timeFrame: at baseline and 30 minutes later (after interventions or sham)
measure: Visual Mood Score
timeFrame: at baseline and 30 minutes later (after interventions or sham)
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: