Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA
- Conditions
- CTEPH
- Interventions
- Behavioral: respiratory and exercise therapy
- Registration Number
- NCT01393327
- Lead Sponsor
- Heidelberg University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Consent form
- men and women> 18 years <80 years
- CTEPH after pulmonary endarterectomy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Respiratory and exercise therapy respiratory and exercise therapy Early after PEA postoperative three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks.
- Primary Outcome Measures
Name Time Method Change of peak O2 uptake (VO2peak) during exercise 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 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
- Secondary Outcome Measures
Name Time Method Change in cardiac index (CI) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in diastolic pulmonary arterial pressure (dPAP) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in exercise capacity - workload up to 15 weeks after start of rehabilitation with exercise training recumbent bike (Workload in Watts) during cycle Ergometer test
Change in right atrial area up to 15 weeks after start of rehabilitation with exercise training Change of cm2 of right atrial area measured by 2D echocardiography
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 number of adverse events and serious adverse events
Change in right ventricular pressure (RVP) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in pulmonary arterial wedge pressure (PAWP) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in right atrial pressure (RAP) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in systolic pulmonary arterial pressure (sPAP) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in right atrial pressure (RAP) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in right ventricular pressure (RVP) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in systolic pulmonary arterial pressure (sPAP) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in diastolic pulmonary arterial pressure (dPAP) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in mean pulmonary arterial pressure (mPAP) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in mean pulmonary arterial pressure (mPAP) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in venous oxygen saturation from pulmonary artery (SvO2) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in cardiac index (CI) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in pulmonary arterial wedge pressure (PAWP) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in cardiac output (CO) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in cardiac output (CO) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in pulmonary vascular resistance (PVR) during exercise up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics during exercise
Change in venous oxygen saturation from pulmonary artery (SvO2) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in exercise capacity - respiratory economy up to 15 weeks after start of rehabilitation with exercise training EqO2, EqCO2 assessed during cardiopulmonary exercise testing
Change of laboratory parameters of right heart function up to 15 weeks after start of rehabilitation with exercise training Measurement of NT-proBNP
Change in visual right heart pump function 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
Change in pulmonary vascular resistance (PVR) at rest up to 15 weeks after start of rehabilitation with exercise training Changes in hemodynamics at rest
Change in exercise capacity assessed by six minute walking test up to 15 weeks after start of rehabilitation with exercise training Six Minute Walking distance (6MWD) in meters
Change in right ventricular area up to 15 weeks after start of rehabilitation with exercise training Change of cm2 of right ventricular area measured by 2D echocardiography
Trial Locations
- Locations (1)
Center for pulmonary Hypertension, Thoraxclinic Heidelberg
🇩🇪Heidelberg, Germany