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Recruiting NCT07355192

Hybrid Group Singing

No phase Interventional Coronary Artery Disease Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: group singing (hybrid format), instructional sing-along video series.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Elderly. Basic parameters: 55 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral group singing (hybrid format)
    12-weeks of group singing, combination of in-person and virtual sessions, 3 times weekly
  • Behavioral instructional sing-along video series
    12-week solo singing video series done independently, 3 times weekly

Primary outcome measures

  • Adherence [Time frame: 12 weeks]
Secondary outcome measures (2)
  • Enrollment rate [Time frame: 12 weeks]
  • Retention rate [Time frame: out of 2 study visits (baseline and post-intervention visit after 12 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Medical College of Wisconsin — Milwaukee

Publications

  • 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

Identifiers

NCT: NCT07355192 · 00056785

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗