Singing and Cardiovascular Health in Older Adults

Cardiovascular Diseases Clinical Trial

Official title:

Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients With Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121741
• Other study ID #: 35864
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2023
• Source: Medical College of Wisconsin
• Contact: Amberly A Anger
• Phone: 414-805-3148
• Email: AANGER[@]MCW.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: January 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Health
• Cardiovascular Risk Factor

Intervention

Other:
• Singing with Music Therapist
Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Music therapy sessions will be led by Erica Flores, MT-BC, WMTR, Owner of Healing Harmonies Music Therapy, or a member of her team. Erica and her team of MTs were trained in Neurological Music Therapy.
• Singing with Guided Video
The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.
• Control Arm
30 minute rest period, no singing will take place during this arm. During this rest period a member of the study team will assist the subject in a hearing test using headphones, a tablet, and a trumpet app. This is done to asses the current hearing level of the subject.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8	measure the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8	at baseline and 30 minutes later (after interventions or sham)
Other	Visual Mood Score	Arts Observation Scale to evaluate the effect of performing arts activities in healthcare settings. Two reactions (relaxation and distraction) will be scored by the research coordinator nurse based on direct observation of the subjects during the singing intervention. The qualitative portion of this instrument enables the collection of personal feedback and quotations from subjects. Observers (research team) can also gather more detailed accounts of subjects' responses to activities, including experience and perceptions	at baseline and 30 minutes later (after interventions or sham)
Primary	change in vascular (endothelial) function	Measure endothelial function and brachial artery flow-mediated dilation	At baseline and after 30-minute singing and sham intervention(s)
Primary	change in vascular (endothelial) function	Measure endothelial function (reactive hyperemia index, and PAT ratio) through finger plethysmography using EndoPAT	At baseline and after 30-minute singing and sham intervention(s)
Secondary	level of exertion achieved during singing	BORG Rating of Perceived Exertion	after 30-minute singing (and sham) interventions
Secondary	level of exertion achieved during singing	percent of maximum predicted heart rate achieved	after 30-minute singing (and sham) interventions
Secondary	cardiac hemodynamics	heart rate variability will be measured before, during and post singing	at baseline and after 30-minute singing and sham intervention(s)