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Completed

NCT Number: NCT04121741

Singing and Cardiovascular Health in Older Adults

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.

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Key information

Conditions

Cardiovascular Diseases Cardiovascular Health Cardiovascular Risk Factor

Age range

55 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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:

  • a 30-minute period of guided singing from an in-person music therapist
  • a 30-minute period of singing along to an instructional video including a professor of voice and "inexperienced, older singing student"
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Singing with Music Therapist

Other

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

Other

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

Other

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.

Primary outcomes

  1. Change in FMD%

    Time frame: 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%.

  2. Change in Reactive Hyperemia Index (RHI)

    Time frame: 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.

  3. Change in Framingham Reactive Hyperemia Index (fRHI)

    Time frame: 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 outcomes

  1. BORG Rating of Perceived Exertion

    Time frame: 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.

  2. Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)

    Time frame: 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).

  3. Change in RMSSD (Root Mean Square of Successive Differences)

    Time frame: 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).

  4. Change in HF Power (High-frequency Power)

    Time frame: 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).

  5. Change in LF Power (Low-frequency Power)

    Time frame: 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).

  6. Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)

    Time frame: 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).

  7. Change in LnHF Power (Natural Log (Milliseconds Squared))

    Time frame: 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).

Other outcomes

  1. Change in TNF-alpha, IL-1 Beta, IL-6, and IL-8

    Time frame: at baseline and 30 minutes later (after interventions or sham)

    measure the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8

  2. Visual Mood Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2019
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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