Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference in CO2 production (VCO2) [L/min]
研究概览
简要总结
The study aims to assess the effect of music on the heart resulting in a change in their exercise capacity among systolic heart failure patients undergoing Cardiopulmonary Exercise testing.
详细描述
Studies have previously shown the positive impact of music on the autonomic nervous system, neurohormonal and cardiovascular system. In addition, a previously published study found a positive impact of music resulting in an improvement of quality of life (QOL) in heart failure patients. Proposed mechanisms of benefit of music in heart failure include a reduction in sympathetic activity, and modulation of parasympathetic activity. Further, reduction in anxiety and arterial relaxation are thought to be beneficial effects of music. It is hypothesized that heart failure patients listening to music would have better exercise stress test performance and increased exercise time.
Adult patients with systolic heart failure scheduled to undergo Cardiopulmonary Exercise (CPX) testing at the Gill Heart and Vascular Institute will be recruited.
While the patients are undergoing Cardiopulmonary exercise testing, patients randomized to the 'music arm' will listen to pre-selected upbeat music during their duration of the exercise testing via headphones that will be provided to patients by the study personnel. The patients who are randomized to 'non-music arm' in which their headphones will not play music and the patients will perform the cardiopulmonary exercise testing as usual.
Standard clinical care is performing cardiopulmonary exercise testing without any music.
The investigators will then compare the results of CPX study of the two arms to assess the impact of music on exercise performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age >18 years)
- •Able to consent
- •English speaking
排除标准
- •Severe hearing deficiency
- •Unable to exercise.
研究组 & 干预措施
Music
Music arm will listen to pre-selected music during their duration of the exercise testing via headphones that will be provided to the patients by the study personnel.
干预措施: Music (Other)
Non-music
Non-music arm will not have pre-selected music playing during their duration of the exercise testing via the headphones provided to the patients by the study personnel.
结局指标
主要结局
Difference in CO2 production (VCO2) [L/min]
时间窗: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in Ventilatory Threshold (VT) [L]
时间窗: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in respiratory rate (RR) [Breaths per minute]
时间窗: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in O2 consumption (VO2) [L/min]
时间窗: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in respiratory exchange ratio (RER)
时间窗: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in Minute Ventilation (VE) [L/min]
时间窗: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in Ventilatory Equivalent of CO2 (VE/VCO2)
时间窗: 15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Assess above performance parameters in CPX and compare between Music and Non-Music arm
次要结局
- Difference in Exercise time [mm:ss](15 minutes (Start to end of CPX study))
- Difference in Work rate [watt](15 minutes (Start to end of each CPX study))
- Difference in Heart Rate [Beats per minute](15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths))
- Difference in O2 Pulse [ml](15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths))
- Difference in Systolic and Diastolic Blood Pressure [mmHg](15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths))
研究者
Maya Ignaszewski
Assistant Professor
University of Kentucky