Recruiting

Singing Intervention

Sponsor:

Medical College of Wisconsin

Code:

NCT07355192

Conditions

Coronary Artery Disease

Elderly

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

group singing (hybrid format)

instructional sing-along video series

Study Details

Brief summary:

The overall objective of the planned future clinical trial is to test the investigator's central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering cardiovascular disease (CVD) risk. The overall objective of this study is to refine and protocolize the singing interventions and test the feasibility of the future trial design. The investigative team has previously studied solo singing. Collective singing, as in a choir or small group, is associated with a positive sense of social inclusion, well-being, and improved mood, including in older adults.

Conditions

Coronary Artery Disease

Elderly

Study ID

NCT07355192

Start date

May 11, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • history of coronary artery disease (defined as having at least 1 of the following: myocardial infarction, coronary stent, PCI, CABG, coronary stenosis at least 50%, or coronary artery calcification score at least 300 Agatston units)

Exclusion Criteria:

  • Parkinson's disease or tremor
  • upper arm fistula
  • fingernail onychomycosis
  • 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)
  • unstable CAD (active symptoms of chest discomfort)
  • supplemental oxygen use
  • more than mild cognitive impairment (as documented in the medical record by patient's treatment teams)
  • inability to follow study procedures
  • non-English speaking

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: group singing (hybrid format)

Group singing sessions are a hybrid of in-person and virtual participation with in-person participation encouraged. 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).

active comparator: individual sing-along video series

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.

Interventions

group singing (hybrid format)

12-weeks of group singing, combination of in-person and virtual sessions, 3 times weekly

instructional sing-along video series

12-week solo singing video series done independently, 3 times weekly

Primary outcome measure

  • Adherence [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Jacquelyn Kulinski, MD, FASPC

414-955-6896jakulinski@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • group singing
  • individual singing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-07-13.