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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT010680 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Singing intervention 1 | Active Comparator | 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. |
|
| Singing intervention 2 | Active Comparator | 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. |
|
| Control/sham intervention | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FMD% | Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%. | 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. | 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. | At baseline and after 30-minute singing and control intervention(s) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after 30-minute singing (and sham) interventions |
| Change in SDNN (Standard Deviation of Normal-to-Normal Intervals) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40357442 | Derived | Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of singing on vascular health in older adults with coronary artery disease: a randomized, crossover trial. Front Cardiovasc Med. 2025 Apr 28;12:1546462. doi: 10.3389/fcvm.2025.1546462. eCollection 2025. | |
| 39108506 | Derived | Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomization ABC | A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. 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. 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. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. 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. |
| FG001 | Randomization ACB | A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. 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. 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. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. 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. |
| FG002 | Randomization BAC | A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. 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. 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. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. 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. |
| FG003 | Randomization BCA | A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. 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. 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. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. 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. |
| FG004 | Randomization CAB | A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. 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. 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. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. 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. |
| FG005 | Randomization CBA | A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. 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. 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. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All 65 participants who signed informed consent and participated in this study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in FMD% | Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%. | Poor quality FMD measurements were excluded from the analysis | Posted | Mean | Standard Error | FMD percent | At baseline and after 30-minute singing and control intervention(s) |
|
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.
For all adverse events, we will determine severity (mild, moderate, severe) and relationship, if any, to the protocol (unrelated, possibly related, or definitely related). The PI will be informed of all serious adverse events as soon as they occur.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Singing Intervention 1 | Singing Video Intervention 30 minutes | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event - Internal, Mild, Expected, Definitely Related to the Protocol | Injury, poisoning and procedural complications | Systematic Assessment | Following FMD, subject's arm was red, painless. PI advised to not perform second FMD. Resolved spontaneously. |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator: Jacquelyn P Kulinski | Medical College of WI | 414-955-6896 | jakulinski@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2022 | Nov 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2019 | Nov 27, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2023 | Nov 15, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D063346 | Singing |
| ID | Term |
|---|---|
| D010699 | Phonation |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| 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. |
|
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). |
| 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). | 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). | 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). | 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). | 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). | at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s) |
| at baseline and 30 minutes later (after interventions or sham) |
| years |
|
| Age, Customized | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| History of Heart Attack (Myocardial Infarction) | Number | participants |
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| History of Stent Placement | Number | participants |
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| History of Coronary Artery Bypass (CABG) | Number | participants |
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| History of Diabetes Mellitus | Number | participants |
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| History of Hypertension | Number | participants |
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| History of High Cholesterol | Number | participants |
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| History of Chronic Kidney Disease | Number | participants |
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| History of Respiratory Illness | Number | participants |
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| History of Past Smoking | Number | participants |
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| History of Heart Failure | Number | participants |
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| Body Mass Index (BMI) Category | Number | participants |
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| Godin Category | Number | participants |
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| Hearing Test Results - Left Ear | One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update. | Number | participants |
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| Hearing Test Results - Right Ear | One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update. | Number | participants |
|
| OG001 | Singing Intervention 2 | 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. 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. |
| OG002 | Control/Sham Intervention | 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. 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. |
|
|
|
| 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. | Poor quality EndoPAT measurements were excluded from the analysis | Posted | Mean | Standard Error | Index | At baseline and after 30-minute singing and control intervention(s) |
|
|
|
|
| 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. | Poor quality EndoPAT measurements were excluded from the analysis | Posted | Mean | Standard Error | Index | At baseline and after 30-minute singing and control intervention(s) |
|
|
|
|
| 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. | One participant who did not complete all three interventions was not included in final analysis | Posted | Mean | Standard Error | Units on a scale | after 30-minute singing (and sham) interventions |
|
|
|
| Secondary | 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). | One participant who did not complete all three interventions was not included in final analysis | Posted | Mean | Standard Error | percent change | at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s) |
|
|
|
| Secondary | 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). | One participant who did not complete all three interventions was not included in final analysis | Posted | Mean | Standard Error | percent change | at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s) |
|
|
|
| Secondary | 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). | One participant who did not complete all three interventions was not included in final analysis | Posted | Mean | Standard Error | milliseconds-squared | at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s) |
|
|
|
| Secondary | 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). | One participant who did not complete all three interventions was not included in final analysis | Posted | Mean | Standard Error | milliseconds-squared | at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s) |
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| Secondary | 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). | One participant who did not complete all three interventions was not included in final analysis | Posted | Mean | Standard Error | Ratio | at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s) |
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| Secondary | 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). | One participant who did not complete all three interventions was not included in final analysis | Posted | Mean | Standard Error | natural log (milliseconds-squared) | at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s) |
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| Other Pre-specified | 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 | Not Posted | at baseline and 30 minutes later (after interventions or sham) | Participants |
| Other Pre-specified | 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 | Not Posted | at baseline and 30 minutes later (after interventions or sham) | Participants |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Singing Intervention 2 | Singing Coach Intervention 30 minutes | 0 | 65 | 0 | 65 | 0 | 65 |
| EG002 | Control | Rest Period 30 minutes | 0 | 65 | 0 | 65 | 2 | 65 |
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| Adverse Event - Internal, Moderate, Unexpected, Unrelated to the Protocol | Cardiac disorders | Systematic Assessment | Subject came into study visit and blood pressure was elevated by the end of the study visit. PI was notified and subject left to seek medical care. Subject's blood pressure normalized and testing was normal, no interventions were needed. |
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Not provided
Not provided
Please reference the following pre-print manuscript for additional statistical analyses. Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710. |
| Regression, Linear | Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design. | 0.462 | Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p<0.0167. | Mean Difference (Final Values) | 0.09 | Standard Error of the Mean | 0.12 | 2-Sided | Estimated mean difference for RHI (singing coach intervention compared to control) is shown. Estimates of RHI for singing video intervention compared to control also performed. | Superiority | Please reference the following pre-print manuscript for additional statistical analyses. Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710. |
Please reference the following pre-print manuscript for additional statistical analyses. Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710. |
| Regression, Linear | Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design. | 0.570 | Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p<0.0167. | Mean Difference (Final Values) | 0.11 | Standard Error of the Mean | 0.18 | 2-Sided | Estimated mean difference for fRHI (singing coach intervention compared to control) is shown. Estimates of fRHI for singing video intervention compared to control also performed. | Superiority | Please reference the following pre-print manuscript for additional statistical analyses. Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710. |
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