Singing and Cardiovascular Health in Older Adults

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04121741

Enrollment

Registered

2019-10-10

Start date

2020-01-17

Completion date

2023-08-18

Last updated

2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Health, Cardiovascular Risk Factor

Keywords

Singing

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.

Interventions

OTHERSinging 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.

OTHERSinging 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.

OTHERControl 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 79 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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.
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 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%.

Secondary

Measure	Time frame	Description
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/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).
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).
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).

Other

Measure	Time frame	Description
Change in TNF-alpha, IL-1 Beta, IL-6, and IL-8	at baseline and 30 minutes later (after interventions or sham)	measure the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8
Visual Mood Score	at baseline and 30 minutes later (after interventions or sham)	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

Countries

United States

Participant flow

Recruitment details

Recruitment began in January of 2020 and concluded in August 2023 as enrollment goals were met successfully. Subjects were identified by reviewing the electronic medical records of patients visiting the outpatient clinic. Subjects were also identified using a cohort discovery tool from the institution's Clinical Research Data Warehouse.

Pre-assignment details

Randomized, single-blind, crossover, sham procedure-controlled design. Each subject will have 3 visits: (1) a 30-minute period of guided singing from a music therapist, (2) a 30-minute period of singing along to an instructional video (3) a 30-minute rest period without any intervention. There will be a washout period between visits of a minimum of 2 days and a maximum of 7 days (to allow for wash-out effects of the prior intervention). Visits are coded ABC. A-Control, B-Coach, C-video

Participants by arm

Arm	Count
Entire Study Population All 65 participants who signed informed consent and participated in this study.	65
Total	65

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Protocol Violation	1	0	0	0	0	0

Baseline characteristics

Characteristic	Entire Study Population
Age, Customized Age at Screening	67.7 years
Body Mass Index (BMI) Category Healthy weight 18.5 - 24.9	12 participants
Body Mass Index (BMI) Category Obese 30 or greater	32 participants
Body Mass Index (BMI) Category Overweight 25 to 29.9	17 participants
Body Mass Index (BMI) Category Underweight <18.5	4 participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Godin Category 14-23 Moderately Active	10 participants
Godin Category 24 or more Active	45 participants
Godin Category Less than 14 Insufficiently Active	10 participants
Hearing Test Results - Left Ear Mild Loss	14 participants
Hearing Test Results - Left Ear Moderate Loss	22 participants
Hearing Test Results - Left Ear Normal	20 participants
Hearing Test Results - Left Ear Severe Loss	8 participants
Hearing Test Results - Right Ear Mild Loss	8 participants
Hearing Test Results - Right Ear Moderate Loss	25 participants
Hearing Test Results - Right Ear Normal	22 participants
Hearing Test Results - Right Ear Severe Loss	9 participants
History of Chronic Kidney Disease	10 participants
History of Coronary Artery Bypass (CABG)	18 participants
History of Diabetes Mellitus	19 participants
History of Heart Attack (Myocardial Infarction)	41 participants
History of Heart Failure	12 participants
History of High Cholesterol	55 participants
History of Hypertension	49 participants
History of Past Smoking	26 participants
History of Respiratory Illness	18 participants
History of Stent Placement	47 participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	7 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	56 Participants
Region of Enrollment United States	65 participants
Sex: Female, Male Female	26 Participants
Sex: Female, Male Male	39 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 65	0 / 65	0 / 65
other Total, other adverse events	0 / 65	0 / 65	2 / 65
serious Total, serious adverse events	0 / 65	0 / 65	0 / 65

Outcome results

Primary

Change in FMD%

Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.

Time frame: At baseline and after 30-minute singing and control intervention(s)

Population: Poor quality FMD measurements were excluded from the analysis

Arm	Measure	Value (MEAN)	Dispersion
Singing Intervention 1	Change in FMD%	-0.06 FMD percent	Standard Error 0.3
Singing Intervention 2	Change in FMD%	-0.11 FMD percent	Standard Error 0.31
Control/Sham Intervention	Change in FMD%	-0.06 FMD percent	Standard Error 0.31

p-value: 0.864Regression, Linear

p-value: 0.913Regression, Linear

Primary

Change in Framingham Reactive Hyperemia Index (fRHI)

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.

Time frame: At baseline and after 30-minute singing and control intervention(s)

Population: Poor quality EndoPAT measurements were excluded from the analysis

Arm	Measure	Value (MEAN)	Dispersion
Singing Intervention 1	Change in Framingham Reactive Hyperemia Index (fRHI)	0.8 Index	Standard Error 0.1
Singing Intervention 2	Change in Framingham Reactive Hyperemia Index (fRHI)	0.6 Index	Standard Error 0.1
Control/Sham Intervention	Change in Framingham Reactive Hyperemia Index (fRHI)	0.6 Index	Standard Error 0.1

p-value: 0.005Regression, Linear

p-value: 0.57Regression, Linear

Primary

Change in Reactive Hyperemia Index (RHI)

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.

Time frame: At baseline and after 30-minute singing and control intervention(s)

Population: Poor quality EndoPAT measurements were excluded from the analysis

Arm	Measure	Value (MEAN)	Dispersion
Singing Intervention 1	Change in Reactive Hyperemia Index (RHI)	0.22 Index	Standard Error 0.1
Singing Intervention 2	Change in Reactive Hyperemia Index (RHI)	0.19 Index	Standard Error 0.11
Control/Sham Intervention	Change in Reactive Hyperemia Index (RHI)	0.12 Index	Standard Error 0.09

p-value: 0.29Regression, Linear

p-value: 0.462Regression, Linear

Secondary

BORG Rating of Perceived Exertion

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.

Time frame: after 30-minute singing (and sham) interventions