The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes in exercise capacity parameters at 12-weeks.
研究概览
简要总结
Previous studies have evaluated the effects of inspiratory muscle training in patiens with heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic role of inspiratory muscle training in patients with heart failure and preserved ejection fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living With Heart Failure Questionnaire) in patients with heart failure with preserved ejection fraction and non-reduced inspiratory muscle strength.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) previous history of symptomatic heart failure (New York Heart Association [NYHA] functional class ≥II)
- •b) evidence of normal left ventricular ejection fraction, defined by an ejection fraction >0.50 and an end-diastolic diameter <60 mm by 2D echocardiography
- •c) relevant structural heart disease (left ventricle hypertrophy/left atrial enlargement) and/or diastolic dysfunction estimated by 2D echocardiography
- •d) clinical stability, including no admissions in the past 30 days
排除标准
- •a) Patients unable to perform a valid baseline exercise test.
- •b) Unstable angina, myocardial infarction or cardiac surgery within the previous three months.
- •c)Known chronic metabolic, orthopedic, infectious disease or previous pulmonary disease;
- •d)Treatment with steroids, hormones, or cancer chemotherapy;
- •e)Reduced maximal inspiratory pressure according to age and sex;
- •f)Active smokers
- •g)Acute decompensation;
- •h)Other comorbidity with an expectancy of life less than one year
结局指标
主要结局
Changes in exercise capacity parameters at 12-weeks.
时间窗: 12 weeks
Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
次要结局
- Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.(12 weeks)
研究者
Julio Nuñez
MD, PhD
University of Valencia