ElderlyGOT VOICENCT07881692
GOT VOICE GROUP SINGING
A study testing In-Person Group Singing, instructional sing-along video series and Weekly health education in people with Elderly and Coronary Arterial Disease (CAD), run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Unlike traditional physical exercise, the impact of singing on cardiovascular health has not been extensively studied. Endothelial dysfunction predicts cardiovascular events, and physical exercise improves vascular endothelial function. Read more about this study
- Who is it for?
- Ages 55 to 89 years
- Conditions the study is for
- Elderly, Coronary Arterial Disease (CAD)
- What is being tested?
- In-Person Group Singing, instructional sing-along video series and Weekly health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥55 up to 89 years old
- Known history of stable coronary artery disease (over 1 year out from a coronary stent, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting)
Who cannot join
- Parkinson's disease or tremor, upper arm fistula, or fingernail onychomycosis (all impact assessment of vascular function at the fingertips), pregnancy, current tobacco use, current illicit drug use, current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men), more than mild cognitive impairment (as documented in the medical record by patient's treatment teams) or inability to follow study procedures, and non-English speaking.
- Baseline hearing will be assessed with a tablet-based tool, which we have successfully used in the past. Those with severe hearing loss will be ineligible.
- Participants cannot currently be enrolled in a traditional or intensive cardiac rehabilitation program.
- Individuals with unstable cardiovascular conditions (e.g., uncontrolled arrhythmias, unstable angina, decompensated heart failure, or uncontrolled hypertension) will be excluded from participation.
- Participants with severe or unstable respiratory disease, acute respiratory infections, or conditions that would limit safe participation in singing exercises will be excluded or discussed with their pulmonologist. For participants with stable chronic respiratory conditions, participation will be permitted provided symptoms are well managed and do not interfere with the ability to engage safely in the intervention. We made this decision because there is a substantial body of literature examining singing interventions in individuals with COPD, often under the title "Singing for Lung Health (SLH)." These studies generally report that singing is safe for people with stable COPD and may improve quality of life, breathing control, respiratory muscle function, and exercise tolerance.
- Life expectancy is less than 2 years
- Active malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Jacquelyn Kulinski, MD, FASPC, 414-955-6896, jakulinski@mcw.edu
Ryan Kacala, 414-955-6885, rkacala@mcw.edu
About this study
Official title: Group Singing or Solo Singing to Improve Vascular Health in Older Adults With Coronary Artery Disease: A Feasibility Study
Unlike traditional physical exercise, the impact of singing on cardiovascular health has not been extensively studied. Endothelial dysfunction predicts cardiovascular events, and physical exercise improves vascular endothelial function. In a rigorously conducted randomized, cross-over control study, our team is the first to demonstrate that 30 minutes of solo singing improves endothelial function acutely, regardless of singing expertise. Changes were more robust in subjects with baseline endothelial dysfunction (i.e., those with established coronary artery disease). The improvements occurred in microvascular, but not macrovascular, endothelial function. The observed change in microvascular function translates into a ~25% reduction in cardiovascular disease (CVD) risk, which is comparable to traditional cardiac rehabilitation program participation.
Based on our prior research, the overall objective of the planned future RCT is to test our central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering CVD risk. The overall objective of this project, titled "GrOup singing or solo singing To improve Vascular health in Older adults wIth Coronary artery disEase (GOT VOICE): A Feasibility Study", is to refine and protocolize the singing interventions and test the feasibility of our future trial design.
- Conditions
- Elderly, Coronary Arterial Disease (CAD)
- Being tested
- In-Person Group Singing, instructional sing-along video series, Weekly health education
- Keywords
- Group Singing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Group SingingBehavioural
12-weeks of group singing in-person, 3 times weekly with additional weekly health education
instructional sing-along video seriesBehavioural
12-week solo singing video series done independently, 3 times weekly with additional weekly health education
Weekly health educationBehavioural
One health education topic will be provided for participants to review weekly in the form of a document
| Study group | Role | What they receive |
|---|---|---|
| Group Singing | Active comparator | Group singing sessions are conducted in an in-person format. Intake forms will be used to assess musical preference, prior music experience, and pertinent medical conditions to consider. Songs will be selected based on music preference of the subjects. At the start of each session, the music therapist will review the importance of singing and lead the group in taking deep breaths together. Throughout sessions, the therapist will encourage subjects to sing as much as possible, explaining that it's not about how they sound but how they feel. Initially, the group singing format will be 40 minutes of singing (includes a vocal warm-up), three times weekly, for a total of 12 weeks. The total singing time is the same as in the solo singing video arm. Based on focus group feedback, the formats could change. However, we will aim to keep total singing time the same (i.e., 120 minutes of singing per week). Each week, the group will also get a health education document to review. Receives: Behavioral: In-Person Group Singing |
| Individual Sing-along Video Series | Active comparator | Participants in this arm watch and sing to an online video series independently. The video series is created by a professor of voice with older students in the videos. We plan to use REDCap to deliver the assigned videos at set times and frequencies and display the videos in an embedded audio player for the subjects. Use of REDCap will allow us to track when subjects are watching the videos with reminders sent up to five times. We will also include 2 questions at the end on how much they enjoyed the video (scale 1-10) and how much of the 40 minutes were sung. Inserting questions at the end confirms that participants likely viewed the entire video. Each week, the group will also get a health education document to review. Receives: Behavioral: instructional sing-along video series |
| Health Education Arm | Active comparator | Participants receive a weekly health education document to review. Receives: Behavioral: Weekly health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant adherence
Participant attendance (out of 36 total sessions) by those enrolled
Measured: 12 weeks
Retention rate
Proportion of enrolled subjects who complete all 3 study visits during the 6 months of study participation.
Measured: 6 months
Dropout rate (acceptability)
Percent of enrolled subjects who drop out of study participation during the 12 weeks of active study participation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jacquelyn Kulinski, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881692
- Sponsor's protocol ID
- PRO00056586
- Other IDs
- 1R34AT013239-01A1
- Acronym
- GOT VOICE
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Singing or Solo Singing to Improve Vascular Health in Older Adults With Coronary Artery Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07881692
- Acronym / sponsor ID
- GOT VOICE / PRO00056586
- Conditions
- Elderly, Coronary Arterial Disease (CAD)
- Keywords
- Group Singing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unlike traditional physical exercise, the impact of singing on cardiovascular health has not been extensively studied. Endothelial dysfunction predicts cardiovascular events, and physical exercise improves vascular endothelial function. In a rigorously conducted randomized, cross-over control study, our team is the first to demonstrate that 30 minutes of solo singing improves endothelial function acutely, regardless of singing expertise. Changes were more robust in subjects with baseline endothelial dysfunction (i.e., those with established coronary artery disease). The improvements occurred in microvascular, but not macrovascular, endothelial function. The observed change in microvascular function translates into a ~25% reduction in cardiovascular disease (CVD) risk, which is comparable to traditional cardiac rehabilitation program participation.
Based on our prior research, the overall objective of the planned future RCT is to test our central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering CVD risk. The overall objective of this project, titled "GrOup singing or solo singing To improve Vascular health in Older adults wIth Coronary artery disEase (GOT VOICE): A Feasibility Study", is to refine and protocolize the singing interventions and test the feasibility of our future trial design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Singing | Active comparator | Behavioral: In-Person Group SingingGroup singing sessions are conducted in an in-person format. Intake forms will be used to assess musical preference, prior music experience, and pertinent medical conditions to consider. Songs will be selected based on music preference of the subjects. At the start of each session, the music therapist will review the importance of singing and lead the group in taking deep breaths together. Throughout sessions, the therapist will encourage subjects to sing as much as possible, explaining that it's not about how they sound but how they feel. Initially, the group singing format will be 40 minutes of singing (includes a vocal warm-up), three times weekly, for a total of 12 weeks. The total singing time is the same as in the solo singing video arm. Based on focus group feedback, the formats could change. However, we will aim to keep total singing time the same (i.e., 120 minutes of singing per week). Each week, the group will also get a health education document to review. |
| Individual Sing-along Video Series | Active comparator | Behavioral: instructional sing-along video seriesParticipants in this arm watch and sing to an online video series independently. The video series is created by a professor of voice with older students in the videos. We plan to use REDCap to deliver the assigned videos at set times and frequencies and display the videos in an embedded audio player for the subjects. Use of REDCap will allow us to track when subjects are watching the videos with reminders sent up to five times. We will also include 2 questions at the end on how much they enjoyed the video (scale 1-10) and how much of the 40 minutes were sung. Inserting questions at the end confirms that participants likely viewed the entire video. Each week, the group will also get a health education document to review. |
| Health Education Arm | Active comparator | Behavioral: Weekly health educationParticipants receive a weekly health education document to review. |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects ≥55 up to 89 years old
- Known history of stable coronary artery disease (over 1 year out from a coronary stent, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting)
Key exclusion criteria (7 listed)
- Parkinson's disease or tremor, upper arm fistula, or fingernail onychomycosis (all impact assessment of vascular function at the fingertips), pregnancy, current tobacco use, current illicit drug use, current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men), more than mild cognitive impairment (as documented in the medical record by patient's treatment teams) or inability to follow study procedures, and non-English speaking.
- Baseline hearing will be assessed with a tablet-based tool, which we have successfully used in the past. Those with severe hearing loss will be ineligible.
- Participants cannot currently be enrolled in a traditional or intensive cardiac rehabilitation program.
- Individuals with unstable cardiovascular conditions (e.g., uncontrolled arrhythmias, unstable angina, decompensated heart failure, or uncontrolled hypertension) will be excluded from participation.
- Participants with severe or unstable respiratory disease, acute respiratory infections, or conditions that would limit safe participation in singing exercises will be excluded or discussed with their pulmonologist. For participants with stable chronic respiratory conditions, participation will be permitted provided symptoms are well managed and do not interfere with the ability to engage safely in the intervention. We made this decision because there is a substantial body of literature examining singing interventions in individuals with COPD, often under the title "Singing for Lung Health (SLH)." These studies generally report that singing is safe for people with stable COPD and may improve quality of life, breathing control, respiratory muscle function, and exercise tolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Group Singing12-weeks of group singing in-person, 3 times weekly with additional weekly health education | Behavioural | Group Singing |
| instructional sing-along video series12-week solo singing video series done independently, 3 times weekly with additional weekly health education | Behavioural | Individual Sing-along Video Series |
| Weekly health educationOne health education topic will be provided for participants to review weekly in the form of a document | Behavioural | Health Education Arm |
Primary outcome
Participant adherence
Time frame: 12 weeks
Participant attendance (out of 36 total sessions) by those enrolled
Retention rate
Time frame: 6 months
Proportion of enrolled subjects who complete all 3 study visits during the 6 months of study participation.
Dropout rate (acceptability)
Time frame: 12 weeks
Percent of enrolled subjects who drop out of study participation during the 12 weeks of active study participation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Person Group Singing, instructional sing-along video series and Weekly health education in people with Elderly and Coronary Arterial Disease (CAD), run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant adherence (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.