Severe CTEPH leads to an impaired physical capacity and a restricted quality of life and poor prognosis. Pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located in the central pulmonary vessels and therefore can be operated. By this operation the pulmonary artery pressure can be normalised and the patients' survival improved. Up to now, after successful endarterectomy patients only receive anticoagulation. Despite operation many patients remain symptomatic and are restricted in their physical capacity. Therefore a hypothesis of this project is that most of the patients, even after successful operation, show peripheral vascular remodelling with a ventilation-perfusion mismatch and elevated pulmonary pressure during exercise. In this study we aim to analyse how many patients with CTEPH after endarterectomy show elevated pulmonary artery pressures at rest or during exercise and are limited in their physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy. Another aim is to examine whether exercise and respiratory therapy may improve the patients postoperatively. Therefore 30 patients with CTEPH \> six months after endarterectomy, with ongoing restricted exercise capacity shall be included. After baseline examination in the University hospital Heidelberg the patients receive exercise and respiratory therapy for three weeks. The patients will receive further examinations at the end of rehabilitation after 3 weeks and after 15 weeks. All examinations include medical history, family history, physical examination, ECG and echocardiography at rest and during exercise, cardiopulmonary exercise testing, assessment of the respiratory muscle strength, the SF-36 questionnaire for quality of life, laboratory testing and MRI. Rehabilitation will be conducted in the clinic for rehabilitation Koenigstuhl, Heidelberg. Participants will be randomised into two groups, a control group receiving a conventional therapy for three weeks, in which physical exertion is to be avoided and a training group with additional exercise and respiratory therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
control group with no specific training
Thoraxclinic at the University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGChange in 6-Minute walking test
Time frame: after 3 and 15 weeks compared to baseline
Change in quality of life
Time frame: baseline and 15 weeks
physical capacity in the ergometer test
Time frame: baseline, 3 and 15 weeks
change of lung function during 6-minute walking test
Time frame: baseline, 3 and 15 weeks
noninvasive hemodynamic parameters
Time frame: baseline, 3 and 15 weeks
change of systolic pulmonary arterial pressure at rest and during exercise
Time frame: baseline, 3 and 15 weeks
change of WHO functional class
Time frame: baseline, 3 and 15 weeks
change of perfusion parameters (MRI)
Time frame: baseline, 3 and 15 weeks
change of respiratory muscle function
Time frame: baseline and 15 weeks
change of NTproBNP
Time frame: baseline, 3 and 15 weeks
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