Hybrid Group Singing

NCT07355192 | Recruiting

• 1 other identifier: 00056785
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

group singing; individual singing

Outcome Measures

Primary Outcomes (1)

• Adherence

  The mean percent of sessions attended.

  12 weeks

Secondary Outcomes (2)

• Enrollment rate

  12 weeks

• Retention rate

  out of 2 study visits (baseline and post-intervention visit after 12 weeks)

Study Arms (2)

group singing (hybrid format)

ACTIVE COMPARATOR

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).

Behavioral: group singing (hybrid format)

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.

Behavioral: instructional sing-along video series

Interventions

group singing (hybrid format) BEHAVIORAL

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

group singing (hybrid format)

instructional sing-along video series BEHAVIORAL

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

individual sing-along video series

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40357442 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine/Cardiology

Model Details: Parallel with baseline hybrid group randomized design

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)