CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Singing with Music Therapist +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04121741
NCT04121741N/ACompleted

Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients With Cardiovascular Disease

Medical College of Wisconsin·interventional·Posted Oct 10, 2019·Updated Feb 5, 2025

In Brief

A clinical study evaluating Singing with Music Therapist, Singing with Guided Video, and 1 other intervention for Cardiovascular Diseases and 2 related conditions. Completed, enrolled 65 participants across 1 site.

Detailed Summary

Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Older adults are less likely to participate in CR, as comorbidities in this population, including arthritis and chronic obstructive pulmonary disease, make participation difficult. Singing is a physical activity that involves components of the vagal nerves manifested as changes in cardiac autonomic regulation. Unlike physical exercise, the effects of singing on cardiovascular health has not been well-studied. The hypothesis for this project is that older patients with CVD will have favorable improvement in cardiovascular biomarkers, including, endothelial function and heart rate variability (HRV), after 30 minutes of singing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 10, 2019
Enrollment StartJan 17, 2020
Primary CompletionAug 18, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.7 years ago

Interventions

Singing with Music Therapistother

Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Music therapy sessions will be led by Erica Flores, MT-BC, WMTR, Owner of Healing Harmonies Music Therapy, or a member of her team. Erica and her team of MTs were trained in Neurological Music Therapy.

Singing with Guided Videoother

The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.

Control Armother

30 minute rest period, no singing will take place during this arm. During this rest period a member of the study team will assist the subject in a hearing test using headphones, a tablet, and a trumpet app. This is done to asses the current hearing level of the subject.