- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121741
Singing and Cardiovascular Health in Older Adults
Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients With Cardiovascular Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
This proposal seeks to create, optimize and test two different singing interventions in older patients with CVD. The study will consist of three arms, according to a randomized, single-blind, crossover, sham procedure-controlled design. Sixty-five total participants will each have three visits on three different occasions for the following interventions:
- a 30-minute period of guided singing from an in-person music therapist
- a 30-minute period of singing along to an instructional video including a professor of voice and "inexperienced, older singing student"
- a 30-minute sham intervention (subjects will undergo a hearing test)
The goal will be to determine which singing intervention, if any, is superior to the other - as this would be important to guide longer and larger clinical trials in the field. Knowledge gained from this proposal will improve understanding of biologic mechanisms of singing behaviors, as it relates to CVD.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amberly A Anger
- Phone Number: 414-805-3148
- Email: AANGER@MCW.EDU
Study Contact Backup
- Name: Jacquelyn P Kulinski
- Phone Number: 414-955-6896
- Email: jakulinski@mcw.edu
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Contact:
- Jacquelyn P Kulinski
- Phone Number: 414-955-6896
- Email: jakulinski@mcw.edu
-
Contact:
- Amberly A Anger, BS
- Phone Number: 414-805-3148
- Email: aanger@mcw.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English Speaking
- Have a history of coronary artery disease (defined as history of myocardial infarction, coronary stenosis >50%, percutaneous coronary intervention with stent placement, balloon angioplasty, or coronary arterial bypass grafting)
Exclusion Criteria:
- Subjects with a permanent pacemaker or implantable cardioverter defibrillator (ICD) implanted
- Patients with a history of atrial fibrillation, flutter or atrial tachycardia
- Parkinson's disease or a tremor
- Amputated upper extremity or presence of upper-arm (dialysis) fistula
- Fingernail onychomycosis (fungal infections resulting in thickening of the nails)
- Pregnancy
- Current illicit drug use (marijuana, tobacco, cocaine, amphetamines, etc.)
- Current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
- Unstable coronary heart disease (active symptoms of chest discomfort)
- History of a Stroke or TIA or peripheral arterial disease
- Known history of cognitive impairment or inability to follow study procedures
- Cancer requiring systemic treatment within five years of enrollment.
- Subjects requiring supplemental oxygen use
- Non-English speaking subjects (video with lyrics are taped in English)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Singing intervention 1
Instructional sing-a-long video.
A video series will be created and recorded for the purposes of the study.
Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing.
|
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.
|
Active Comparator: Singing intervention 2
In-person music therapy session.
The music therapist will continue to coach throughout the 30-minute session.
Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing.
|
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.
|
Sham Comparator: Control/sham intervention
Subjects will have a 30-minute period of rest sitting upright (as they would be positioned for the singing interventions).
This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements.
During this time, subjects will undergo hearing testing.
Flow Mediated dilation (FMD) and EndoPAT will be measured before and after the 30 minute rest.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in vascular (endothelial) function
Time Frame: At baseline and after 30-minute singing and sham intervention(s)
|
Measure endothelial function and brachial artery flow-mediated dilation
|
At baseline and after 30-minute singing and sham intervention(s)
|
change in vascular (endothelial) function
Time Frame: At baseline and after 30-minute singing and sham intervention(s)
|
Measure endothelial function (reactive hyperemia index, and PAT ratio) through finger plethysmography using EndoPAT
|
At baseline and after 30-minute singing and sham intervention(s)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
level of exertion achieved during singing
Time Frame: after 30-minute singing (and sham) interventions
|
BORG Rating of Perceived Exertion
|
after 30-minute singing (and sham) interventions
|
level of exertion achieved during singing
Time Frame: after 30-minute singing (and sham) interventions
|
percent of maximum predicted heart rate achieved
|
after 30-minute singing (and sham) interventions
|
cardiac hemodynamics
Time Frame: at baseline and after 30-minute singing and sham intervention(s)
|
heart rate variability will be measured before, during and post singing
|
at baseline and after 30-minute singing and sham intervention(s)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8
Time Frame: at baseline and 30 minutes later (after interventions or sham)
|
measure the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8
|
at baseline and 30 minutes later (after interventions or sham)
|
Visual Mood Score
Time Frame: at baseline and 30 minutes later (after interventions or sham)
|
Arts Observation Scale to evaluate the effect of performing arts activities in healthcare settings.
Two reactions (relaxation and distraction) will be scored by the research coordinator nurse based on direct observation of the subjects during the singing intervention.
The qualitative portion of this instrument enables the collection of personal feedback and quotations from subjects.
Observers (research team) can also gather more detailed accounts of subjects' responses to activities, including experience and perceptions
|
at baseline and 30 minutes later (after interventions or sham)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35864
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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