Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements.
研究概览
简要总结
Mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation. The "thoracic pump" is a contributor to venous return that has been largely unexplored in patients with Fontan physiology. Inspiratory muscle training can improve the performance of competitive athletes across a range of sports and can improve quality of life and functional capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and possibly by improving peripheral blood flow during exercise. One could surmise that the effects of these changes would be particularly important in the Fontan population. The investigators propose to study the effects of inspiratory muscle training on exercise and pulmonary function parameters in a cohort of adult Fontan patients.
The investigators hypothesize that a 12-week program of inspiratory muscle training with an inspiratory impedance threshold device will improve inspiratory muscle strength and endurance, and that this will translate into improved exercise performance in patients with Fontan physiology.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Fontan physiology
- •Undergoing cardiopulmonary stress testing
- •Able to complete a previous cardiopulmonary stress test in the preceding 24 months
- •Ability to comply with the inspiratory muscle training protocol
- •Ability to return for repeat stress testing and pulmonary function testing 12 weeks after enrollment
- •Ability to provide informed consent
排除标准
- •Status post cardiac transplantation
- •Current pregnancy or plans to become pregnant within the next 3 months (for females of childbearing potential)
- •Active respiratory infection
- •Active cigarette smoker
- •Baseline oxygen saturation <90% at the previous clinic visit or exercise test
- •Forced expired volume in 1 s and/or vital capacity <60% of predicted at the previous exercise test
- •Cardiac surgery or catheter-based procedure in the preceding 18 months or planned surgery or catheter-based procedure within the next 3 months
研究组 & 干预措施
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
干预措施: THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER (Device)
结局指标
主要结局
Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements.
时间窗: Baseline and after 12 weeks of training
次要结局
- Change in Innocor Measurement (Inert Gas Rebreathing Method) of Cardiac Output at Peak Exercise(12 weeks)
- Change in SF-36 Health Survey Score (Physical Component Summary)(12 weeks)
研究者
Fred Wu
Assistant in Cardiology
Boston Children's Hospital