Effect of an Aerobic Exercise Session on Cardiovascular and Autonomic Parameters of Adults With Hypertrophic Cardiomyopathy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of autonomic system function
研究概览
简要总结
Hypertrophic cardiomyopathy is a genetic heart disease with symptoms that may include dyspnea and fatigue predominantly on exertion, with or without chest pain, palpitations, syncope/presyncope and sudden cardiac death, mostly in young individuals, often without symptoms. Due to the higher cardiovascular risk described for individuals with hypertrophic cardiomyopathy, it is extremely important to create non-pharmacological strategies that can minimize the evolution of cardiovascular risk factors found in this population. The objective of the study will be to evaluate the effect of an aerobic exercise session on the ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability, endothelial function through flow-mediated dilation and systolic and diastolic blood pressure during the 24-hour period in adult individuals with hypertrophic cardiomyopathy. The study design will be a randomized crossover clinical trial with individuals aged 18 to 59 years, of both sexes, randomized by lottery and divided into two groups: Exercise group and control group without exercise. An exercise stress test will be performed and on a new date the individuals will perform a supervised session of moderate-intensity aerobic exercise on a horizontal stationary bicycle for 50 minutes or will remain seated in an air-conditioned room for the same period of time. Subsequently, the procedures will be crossed. It is expected to find improvements in the parameters of endothelial function, autonomic modulation and 24-hour blood pressure in adult individuals with non-obstructive hypertrophic cardiomyopathy undergoing a session of aerobic physical exercise when compared to a control session without exercise.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population will consist of individuals aged between 18 and 59 years with HCM diagnosed via ICFUC medical records.
排除标准
- •Individuals with a history of exercise-induced arrhythmias, a history of aborted sudden death, and the presence of an implantable cardioverter defibrillator will be excluded from the sample. Those with LVOT obstruction at rest ≥50 mmHg on medical therapy, recent septal reduction therapy, pregnancy, class IV symptoms in the New York Heart Association (NYHA) functional classification78, hypotensive response to exercise (drop in systolic BP >20 mmHg in relation to the resting value or during exercise) will also be excluded. Concomitantly, those with systolic dysfunction of left ventricular ejection fraction <50%, myocardial infarction, or previous stroke will be excluded. Hypertensive patients, those with orthopedic limitations, or any physical or mental limitation that prevents them from performing physical exercises will also be excluded.
研究组 & 干预措施
Exercise
An aerobic exercise session on a recumbent exercise bike with a 5-minute warm-up period, followed by a 40-minute cool-down period and ending with a 5-minute cool-down at decreasing speed.
干预措施: Exercise (Other)
Control
The control session will consist of the individual remaining seated for 50 minutes in an air-conditioned room.
结局指标
主要结局
Assessment of autonomic system function
时间窗: From enrollment to the end of treatment at 2 weeks
Ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability by electrocardiogram
次要结局
- Assessment of endothelial function(From enrollment to the end of treatment at 2 weeks)
- Blood pressure assessment(From enrollment to the end of treatment at 2 weeks)