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Singing Therapy for Cardiovascular Health
N/A
Waitlist Available
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 30-minute singing (and sham) interventions
Summary
This trial is testing whether singing can help improve cardiovascular biomarkers in older patients with CVD.
Who is the study for?
This trial is for older adults with a history of coronary artery disease who speak English. It's not suitable for those with pacemakers, ICDs, certain heart rhythm problems, Parkinson's disease or tremors, amputated upper extremity or arm fistula, thickened fingernails due to fungus, pregnant women, drug or heavy alcohol users, unstable coronary heart disease patients, stroke/TIA survivors within five years of cancer treatment requiring systemic therapy.
What is being tested?
The study investigates if singing can improve cardiovascular health in older adults with heart disease. Participants will either sing with a music therapist or follow a guided video; there's also a control group that won't sing. The focus is on how singing affects biomarkers like endothelial function and heart rate variability after 30 minutes.
What are the potential side effects?
Since the intervention involves non-strenuous activity such as singing under guidance without medical treatments involved, significant side effects are not anticipated beyond the normal risks associated with light physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 30-minute singing (and sham) interventions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 30-minute singing (and sham) interventions
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change in vascular (endothelial) function
Secondary study objectives
cardiac hemodynamics
level of exertion achieved during singing
Other study objectives
Visual Mood Score
the change in TNF-alpha, IL-1 Beta, IL-6, and IL-8
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Singing intervention 2Active Control1 Intervention
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.
Group II: Singing intervention 1Active Control1 Intervention
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.
Group III: Control/sham interventionPlacebo Group1 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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
633 Previous Clinical Trials
1,181,644 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Singing intervention 2
- Group 2: Control/sham intervention
- Group 3: Singing intervention 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.