Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA
Condition: CTEPH
Study type: Interventional

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.
    

Intervention name(s): respiratory and exercise therapy
Intervention type(s): Behavioral
Intervention description(s): Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: physical training; remaining post-operative pulmonary vascular changes; right ventricular pump function; PEA