Feasibility and Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Heart Function in Chronic Thromboembolic Pulmonary Hypertension After Thromboendarterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change of peak O2 uptake (VO2peak) during exercise
研究概览
简要总结
Purpose of this study is to investigate whether and to what extent a cautious respiratory and movement therapy can complement medical treatment and 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.
详细描述
Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of acute pulmonary embolism. According to current knowledge, it is caused by non-resolving fibrothrombotic obstructions of large pulmonary arteries. Some patients show an additional small vessel vasculopathy. Both kinds of obstruction lead to an increase in pulmonary vascular resistance (PVR), increase in mean pulmonary arterial pressure (mPAP), progressive right heart failure, and premature death if left untreated. Current guidelines recommend pulmonary endarterectomy (PEA) as the potentially curative treatment of first choice, which aims to remove fibrotic obstructions from the pulmonary vasculature. The survival of patients undergoing PEA surgery ranges between 76 and 91% after 3 years, which is superior to medical treatment in inoperable CTEPH patients. The majority of operated patients experience almost complete normalisation of haemodynamics and improvements in symptoms. However, 17-51% of operated patients will develop persistent or recurrent pulmonary hypertension (PH). Some patients remain limited in their exercise capacity and prognosis. As patients are monitored on an intensive care unit immediately after PEA, immobilisation after the operation may lead to further peripheral deconditioning. A recent study of 251 CTEPH patients with follow-up until 12 months after PEA showed a persistent exercise limitation in almost 40% of patients despite normalisation of PVR and haemodynamics. This limitation was characterised by a multifactorial aetiology also involving respiratory function abnormalities. Previous studies in patients with inoperable or persistent CTEPH have suggested beneficial effects of exercise training as an add-on to targeted medical therapy, increasing exercise capacity, and quality of life (QoL). However, it is not known, whether early rehabilitation with exercise treatment is safe, feasible, and may further improve exercise capacity after PEA. Prospective studies on exercise training for CTEPH patients shortly after PEA surgery are lacking. Furthermore, to the best of our knowledge, there have been no studies yet describing the early effect within the first weeks after PEA. The aim of this study was therefore to assess the feasibility of supervised exercise training in CTEPH patients shortly after PEA. Furthermore, changes of haemodynamic and clinical parameters including oxygen uptake, QoL, exercise capacity, and right heart function assessed by echocardiography and right heart catheterisation were obtained before and shortly after PEA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 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 <80 years
- •CTEPH after pulmonary endarterectomy
排除标准
- •Patients with signs of right heart decompensation
- •acute diseases, infections, fever
- •Serious lung disease with FEV1 <50% or TLC <70% of target
- •Other 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
Change of peak O2 uptake (VO2peak) during exercise
时间窗: up to 15 weeks after start of rehabilitation with exercise training
Change of peak O2 uptake measured by cardiopulmonary exercise test (CPET)
Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA
时间窗: up to 15 weeks after start of rehabilitation with exercise training
Assessment of feasibility and tolerance of exercise rehabilitation directly after PEA assessed by the number of patients completing the exercise rehabilitation program
次要结局
- Change in cardiac index (CI) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in diastolic pulmonary arterial pressure (dPAP) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in exercise capacity - workload(up to 15 weeks after start of rehabilitation with exercise training)
- Change in right atrial area(up to 15 weeks after start of rehabilitation with exercise training)
- Safety of early rehabilitation directly after pulmonary endarterectomy: number of adverse events and serious adverse events(up to 15 weeks after start of rehabilitation with exercise training)
- Change in right ventricular pressure (RVP) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in pulmonary arterial wedge pressure (PAWP) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in right atrial pressure (RAP) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in right atrial pressure (RAP) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in systolic pulmonary arterial pressure (sPAP) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in right ventricular pressure (RVP) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in systolic pulmonary arterial pressure (sPAP) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in diastolic pulmonary arterial pressure (dPAP) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in mean pulmonary arterial pressure (mPAP) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in mean pulmonary arterial pressure (mPAP) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in venous oxygen saturation from pulmonary artery (SvO2) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in pulmonary arterial wedge pressure (PAWP) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in cardiac output (CO) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in cardiac output (CO) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in pulmonary vascular resistance (PVR) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in venous oxygen saturation from pulmonary artery (SvO2) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in cardiac index (CI) during exercise(up to 15 weeks after start of rehabilitation with exercise training)
- Change in exercise capacity - respiratory economy(up to 15 weeks after start of rehabilitation with exercise training)
- Change of laboratory parameters of right heart function(up to 15 weeks after start of rehabilitation with exercise training)
- Change in visual right heart pump function(up to 15 weeks after start of rehabilitation with exercise training)
- Change in pulmonary vascular resistance (PVR) at rest(up to 15 weeks after start of rehabilitation with exercise training)
- Change in exercise capacity assessed by six minute walking test(up to 15 weeks after start of rehabilitation with exercise training)
- Change in right ventricular area(up to 15 weeks after start of rehabilitation with exercise training)
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University