An interventional study of Singing with Music Therapist and Singing with Guided Video in Cardiovascular Diseases, Cardiovascular Risk Factor and Cardiovascular Health, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 55 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
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:
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.
4,905 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 65 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
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.
Other: Singing with Guided Video
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.
Other: Singing with Music Therapist
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.
Other: Control Arm
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.
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.
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.
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)
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)
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)
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
Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)
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).
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in RMSSD (Root Mean Square of Successive Differences)
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).
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in HF Power (High-frequency Power)
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).
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LF Power (Low-frequency Power)
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).
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)
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).
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LnHF Power (Natural Log (Milliseconds Squared))
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).
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
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
Time frame: at baseline and 30 minutes later (after interventions or sham)
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
Time frame: at baseline and 30 minutes later (after interventions or sham)
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.
| Milestone | Randomization ABC | Randomization ACB | Randomization BAC | Randomization BCA | Randomization CAB | Randomization CBA |
|---|---|---|---|---|---|---|
| Started | 11 | 11 | 10 | 11 | 11 | 11 |
| Completed | 10 | 11 | 10 | 11 | 11 | 11 |
| Not completed | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 | 0 |
Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.
| FMD percent | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| Change in FMD% | -0.06 ± 0.30 | -0.11 ± 0.31 | -0.06 ± 0.31 |
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.
| Index | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| Change in Reactive Hyperemia Index (RHI) | 0.22 ± 0.10 | 0.19 ± 0.11 | 0.12 ± 0.09 |
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.
| Index | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| Change in Framingham Reactive Hyperemia Index (fRHI) | 0.8 ± 0.1 | 0.6 ± 0.1 | 0.6 ± 0.1 |
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.
| Units on a scale | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| BORG Rating of Perceived Exertion | 9.98 ± 0.28 | 10.66 ± 0.29 | 6.33 ± 0.10 |
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).
| percent change | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| (Post-Pre) SDNN Relative Difference % | 20.7 ± 9.7 | 22.4 ± 12.8 | 29.5 ± 22.5 |
| (During-Pre) SDNN Relative Difference % | 14.5 ± 9.7 | 23.0 ± 21.1 | 9.2 ± 7.1 |
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).
| percent change | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| (Post-Pre) RMSSD Relative Difference % | 56.9 ± 41.5 | 49.5 ± 38.9 | 62.6 ± 28.0 |
| (During-Pre) RMSSD Relative Difference % | 52.5 ± 27.3 | 80.2 ± 57.3 | 40.6 ± 13.1 |
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).
| milliseconds-squared | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| (Post-Pre) HF Power Absolute Difference | 477.5 ± 346.3 | -334.7 ± 350.4 | 401.0 ± 203.5 |
| (During-Pre) HF Power Absolute Difference | 242.7 ± 261.9 | -141.3 ± 447.1 | 423.7 ± 200.1 |
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).
| milliseconds-squared | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| (Post-Pre) LF Power Absolute Difference | 1318.8 ± 693.9 | 636.2 ± 399.9 | 244.8 ± 350.8 |
| (During-Pre) LF Power Absolute Difference | 525.3 ± 547.9 | 254.1 ± 452.0 | -19.7 ± 191.5 |
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).
| Ratio | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| (Post-Pre) LF/HF Ratio Absolute Difference | 0.6 ± 0.4 | 0.3 ± 0.5 | -1.0 ± 0.6 |
| (During-Pre) LF/HF Ratio Absolute Difference | 2.2 ± 1.2 | -0.2 ± 0.7 | -0.6 ± 0.4 |
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).
| natural log (milliseconds-squared) | Singing Intervention 1 | Singing Intervention 2 | Control/Sham Intervention |
|---|---|---|---|
| (Post-Pre) LnHF Power Absolute Change | 0.1 ± 0.2 | -0.2 ± 0.2 | 0.3 ± 0.2 |
| (During-Pre) LnHF Power Absolute Change | -0.1 ± 0.2 | -0.0 ± 0.2 | 0.3 ± 0.2 |
measure the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Collected over Adverse events (AEs) and serious adverse events (SAEs) will be recorded with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Events will be followed for outcome information until resolution or stabilization. All serious adverse events will be promptly reported to the IRB upon awareness of the events (no longer than 24hrs after event). AEs are reported to the IRB at the annual report.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Singing Intervention 1 | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Singing Intervention 2 | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Control | 0/65 (0%) | 0/65 (0%) | 2/65 (3.1%) |
| Event | Singing Intervention 1 | Singing Intervention 2 | Control |
|---|---|---|---|
| Adverse Event - Internal, Mild, Expected, Definitely Related to the ProtocolInjury, poisoning and procedural complications | 0/65 | 0/65 | 1/65 |
| Adverse Event - Internal, Moderate, Unexpected, Unrelated to the ProtocolCardiac disorders | 0/65 | 0/65 | 1/65 |
Eligible subjects must be English speaking, between the ages of 55-79 years, 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).
| Age, Customized(years) | Entire Study Population |
|---|---|
| Age at Screening | 68.2 (55.1 to 78.7) |
| Age, Customized(years) | Entire Study Population |
|---|---|
| Age at Screening | 67.7 (55.1 to 78.7) |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 26 |
| Male | 39 |
| Ethnicity (NIH/OMB)(Participants) | Entire Study Population |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 64 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Entire Study Population |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 56 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Entire Study Population |
|---|---|
| United States | 65 |
| History of Heart Attack (Myocardial Infarction)(participants) | Entire Study Population |
|---|---|
| Number | 41 |
| History of Stent Placement(participants) | Entire Study Population |
|---|---|
| Number | 47 |
12 further baseline measures are reported on the registry.
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Medical College of Wisconsin