A Pilot Study of Inspiratory Muscle Function and the Effects of Inspiratory Muscle Training in Subjects With Fontan Physiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 主要终点
- Exercise parameters
研究概览
简要总结
Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF). The investigators hypothesized that enhanced respiratory muscle function via inspiratory muscle training (IMT) would improve performance on cardiopulmonary exercise stress testing (CPET).
详细描述
Adult Fontan subjects were recruited from 2 academic medical centers. Following characterization of pulmonary function and functional class, CPET was performed using incremental and constant work rate protocols. Subjects performed 6-8 weeks of IMT using a handheld inspiratory loading device (Threshold®, Philips); both exercise tests were then repeated. Patient-centered outcome data were collected before and after IMT (RAND-36 assessment and New York Heart Association (NYHA) functional class).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single ventricle physiology status post Fontan palliation
排除标准
- •The presence of a sub-pulmonary ventricle
- •Pregnancy or any contraindication to stress testing (e.g., uncontrolled symptomatic arrhythmia, severe systemic ventricular outflow tract obstruction or uncontrolled symptomatic heart failure).
- •Height less than 4'11" due to limitations of the cycle ergometer.
结局指标
主要结局
Exercise parameters
时间窗: 6-8 weeks
Peak VO2 and endurance time are the primary outcome measures
次要结局
未报告次要终点
研究者
Priya Pillutla
Physician Specialist
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center