Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life in Patients With Severe Associated Pulmonary Arterial Hypertension (APAH) as Part of a Congenital Heart Defect With / Without Eisenmenger's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in the maximum 6-minute walk distance (6MGT)
研究概览
简要总结
The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •signed consent form
- •men and women> 18 years <80 years
- •APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)
排除标准
- •Pregnancy or lactation
- •Change in medication during the last 2 months
- •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, recurrent syncope within 4 weeks before study entry
研究组 & 干预措施
Respiratory and exercise therapy
Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group.
干预措施: respiratory and exercise therapy (Other)
Control group without exercise training
patients of the control group continue their sedentary lifestyle without given advice for exercise training.
The time before start of rehabilitation (three months) serves as control group. Afterwards patients take part in the training program as well.
结局指标
主要结局
Changes in the maximum 6-minute walk distance (6MGT)
时间窗: up to 15 weeks
Changes in quality of life
时间窗: up to 15 weeks
次要结局
- Changes in hemodynamics(up to 15 weeks)
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University