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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
32
12-weeks of group singing, combination of in-person and virtual sessions, 3 times weekly
12-week solo singing video series done independently, 3 times weekly
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Adherence
The mean percent of sessions attended.
Time frame: 12 weeks
Enrollment rate
Proportion of subjects who enroll out of all approached, eligible patients and participate in at least one session.
Time frame: 12 weeks
Retention rate
Proportion of enrolled subjects who complete all study visits.
Time frame: out of 2 study visits (baseline and post-intervention visit after 12 weeks)
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