Clinical trial NCT01393327: Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CTEPH
Keywords: physical training
remaining post-operative pulmonary vascular changes
right ventricular pump function
PEA
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change of peak O2 uptake (VO2peak) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
Secondary outcomes:
measure: Change in right atrial pressure (RAP) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in right atrial pressure (RAP) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in right ventricular pressure (RVP) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in right ventricular pressure (RVP) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in systolic pulmonary arterial pressure (sPAP) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in systolic pulmonary arterial pressure (sPAP) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in diastolic pulmonary arterial pressure (dPAP) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in diastolic pulmonary arterial pressure (dPAP) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in mean pulmonary arterial pressure (mPAP) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in mean pulmonary arterial pressure (mPAP) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in pulmonary arterial wedge pressure (PAWP) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in pulmonary arterial wedge pressure (PAWP) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in cardiac output (CO) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in cardiac output (CO) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in pulmonary vascular resistance (PVR) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in pulmonary vascular resistance (PVR) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in venous oxygen saturation from pulmonary artery (SvO2) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in venous oxygen saturation from pulmonary artery (SvO2) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in cardiac index (CI) at rest
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in cardiac index (CI) during exercise
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in exercise capacity assessed by six minute walking test
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in exercise capacity - workload
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in exercise capacity - respiratory economy
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change of laboratory parameters of right heart function
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in right atrial area
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in right ventricular area
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Change in visual right heart pump function
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
measure: Safety of early rehabilitation directly after pulmonary endarterectomy: number of adverse events and serious adverse events
timeFrame: up to 15 weeks after start of rehabilitation with exercise training
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Study officials:
affiliation: Center for pulmonary hypertension, Thoraxclinic Heidelberg
name: Ekkehard Grünig, Professor
role: STUDY_DIRECTOR
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