Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Heidelberg, 69126, Germany
NCT Number: NCT01393327
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Heidelberg, 69126, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
Time frame: 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
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change of peak O2 uptake measured by cardiopulmonary exercise test (CPET)
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Changes in hemodynamics during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Six Minute Walking distance (6MWD) in meters
Time frame: up to 15 weeks after start of rehabilitation with exercise training
recumbent bike (Workload in Watts) during cycle Ergometer test
Time frame: up to 15 weeks after start of rehabilitation with exercise training
EqO2, EqCO2 assessed during cardiopulmonary exercise testing
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Measurement of NT-proBNP
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change of cm2 of right atrial area measured by 2D echocardiography
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change of cm2 of right ventricular area measured by 2D echocardiography
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change of category of right heart pump function (no impairment, slight impairment, moderate impairment, severe impairment) measured by 2D echocardiography
Time frame: up to 15 weeks after start of rehabilitation with exercise training
number of adverse events and serious adverse events
Heidelberg University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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