NCT01394367已完成不适用
Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Improvement of peak O2 uptake (VO2peak) under stress
研究概览
简要总结
Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent form
- •men and women> 18 years <75 years
- •invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable.
排除标准
- •Pregnancy or lactation
- •Change in medication during the last 2 months
- •Patients with signs of right heart decompensation
- •severe walking disturbance
- •uncertain diagnoses
- •No previous invasively confirmation of PH
- •acute diseases, infections, fever
- •Serious lung disease with FEV1 <50% or TLC <70% of target
- •Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, congestive heart failure, significant heart disease, pacemakers, and hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function
结局指标
主要结局
Improvement of peak O2 uptake (VO2peak) under stress
时间窗: up to 15 weeks
Three-week inpatient rehabilitation, continuation of the training program for another 12 weeks at home (exercise group), patients in the control group continued their usual activities. After 15 weeks, training is also offered to patients in the control group.
次要结局
- Changes in hemodynamics at rest and during exercise(up to 15 weeks)
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University
研究点 (2)
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