Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Respiratory and exercise therapy Early after PEA postoperative three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. |
Behavioral: respiratory and exercise therapy
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Secondary Outcome Measures
- 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 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 right ventricular pressure (RVP) during exercise [up to 15 weeks after start of rehabilitation with exercise training]
Changes in hemodynamics during exercise
- 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 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 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 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 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 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 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) at rest [up to 15 weeks after start of rehabilitation with exercise training]
Changes in hemodynamics at rest
- 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) 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 cardiac index (CI) at rest [up to 15 weeks after start of rehabilitation with exercise training]
Changes in hemodynamics at rest
- 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 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 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 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 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Consent form
-
men and women> 18 years <80 years
-
CTEPH after pulmonary endarterectomy
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for pulmonary Hypertension, Thoraxclinic Heidelberg | Heidelberg | Germany | 69126 |
Sponsors and Collaborators
- Heidelberg University
Investigators
- Study Director: Ekkehard Grünig, Professor, Center for pulmonary hypertension, Thoraxclinic Heidelberg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S-488/2009