Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients With Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in FMD%
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Change in FMD%
时间窗: At baseline and after 30-minute singing and control intervention(s)
Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.
Change in Reactive Hyperemia Index (RHI)
时间窗: At baseline and after 30-minute singing and control intervention(s)
Assess microvascular endothelial function by measuring changes in reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in RHI is considered a better outcome.
Change in Framingham Reactive Hyperemia Index (fRHI)
时间窗: At baseline and after 30-minute singing and control intervention(s)
Assess microvascular endothelial function by measuring changes in Framingham reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in fRHI is considered a better outcome.
次要结局
- BORG Rating of Perceived Exertion(after 30-minute singing (and sham) interventions)
- Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)(at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s))
- Change in RMSSD (Root Mean Square of Successive Differences)(at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s))
- Change in HF Power (High-frequency Power)(at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s))
- Change in LF Power (Low-frequency Power)(at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s))
- Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)(at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s))
- Change in LnHF Power (Natural Log (Milliseconds Squared))(at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s))
研究者
Jacquelyn Kulinski
Associate Professor
Medical College of Wisconsin