Health TrialsbyHealthPanel

Hybrid Group Singing

ConditionsCoronary Artery DiseaseElderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-89
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Parkinson's disease or tremor

upper arm fistula

fingernail onychomycosis

pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • group singing (hybrid format)

    Behavioral

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

  • instructional sing-along video series

    Behavioral

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: group singing (hybrid format)Active comparator 1 intervention
Group B: individual sing-along video seriesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adherence

The mean percent of sessions attended.

Time frame
12 weeks

Secondary outcomes

1

Enrollment rate

Proportion of subjects who enroll out of all approached, eligible patients and participate in at least one session.

Time frame
12 weeks
2

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
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