Skip to content

Hybrid Group Singing

Group Singing (Hybrid Format) or Solo Singing in Older Adults With Coronary Artery Disease: A Feasibility Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07355192
Enrollment
32
Registered
2026-01-21
Start date
2026-05-11
Completion date
2028-02-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Elderly

Keywords

group singing, individual singing

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.

Detailed description

The investigator previously studied 65 subjects (mean age 68±7, 40% women) with known CAD in a randomized, control cross-over clinical trial of singing interventions: (1) a 30-minute period of guided singing from an in-person coach (music therapist), (2) a 30-minute period of singing along to an instructional video created by and including a professor of voice and 'inexperienced, older singing student,' and (3) a 'rest' control during which subjects underwent a brief hearing test. Fifty-four percent reported a physical or orthopedic limitation. The primary outcome was vascular endothelial function. There was statistically significant improvement in microvascular endothelial function, as measured by the Framingham reactive hyperemia index (fRHI), after 30 minutes of singing in the instructional video arm (30.9%, p=0.007) compared to the rest control. The observed change in fRHI in the prior clinical trial translates into a \ 25% reduction in CVD risk, which is comparable to traditional cardiac rehabilitation program participation. There was no improvement in macrovascular function, as assessed by brachial artery flow-mediated dilation. The visit with the music therapist coach did not reach statistical significance. Unfortunately, this may have been related to disruption of the in-person coach visits during the COVID pandemic, where the investigator continued the clinical trial but moved to a virtual interaction for the one-on-one coach visits (n=20 out of 65 subjects). Why should group singing be considered? Collective singing, as in a choir or small group, is associated with a positive sense of social inclusion, well-being, and improved mood (less anxiety and depression), including in older adults and may be less anxiety-provoking than one-on-one singing. From a healthcare systems standpoint, group singing would be more efficient and cost-saving (lower per-person cost than individual singing therapy), which has been shown for other treatments without compromising efficacy. With a longer intervention planned for 12 weeks, there will be ample opportunity for the therapeutic relationship between patients and music therapist. The investigator needs to show that this acute, beneficial vascular adaptation is sustained after habitual singing over several weeks, thereby lowering future CVD risk. Before the investigator can execute a large-scale efficacy trial, the study team needs to determine the most acceptable frequency, duration, and delivery format (in-person and/or virtual) that is feasible and tailored to the target population. This study will help the investigator and team protocolize the group singing and video interventions, execute a feasibility trial on a smaller scale, and assess the fidelity of the delivered interventions in preparation for the larger efficacy trial.

Interventions

BEHAVIORALgroup singing (hybrid format)

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

BEHAVIORALinstructional sing-along video series

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

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Parallel with baseline hybrid group randomized design

Eligibility

Sex/Gender
ALL
Age
55 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence12 weeksThe mean percent of sessions attended.

Secondary

MeasureTime frameDescription
Enrollment rate12 weeksProportion of subjects who enroll out of all approached, eligible patients and participate in at least one session.
Retention rateout of 2 study visits (baseline and post-intervention visit after 12 weeks)Proportion of enrolled subjects who complete all study visits.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026