Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- distance walked in 6 minutes
研究概览
简要总结
Background
-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.
Methods
-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.
Prospects
-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe chronic PH who were stable and compensated under optimized medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study will be invited to participate.
- •Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.
排除标准
- •Patients with recent syncope or skeletal or muscle abnormalities prohibiting participation in an exercise program won't be included.
结局指标
主要结局
distance walked in 6 minutes
时间窗: baseline - 15 weeks afterwards
change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire
时间窗: baseline - 15 weeks afterwards
次要结局
- parameters of echocardiography(baseline - 15 weeks afterwards)
- changes in WHO functional classification(baseline - 15 weeks afterwards)
- parameters of gas exchange(baseline - 15 weeks afterwards)
- Borg scale assessed immediately after completion of the stress Doppler echocardiography(baseline - 15 weeks afterwards)
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University