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Completed

NCT Number: NCT01393327

Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA

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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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, 69126, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

respiratory and exercise therapy

Behavioral

Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training

Primary outcomes

  1. Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA

    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

  2. Change of peak O2 uptake (VO2peak) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Change of peak O2 uptake measured by cardiopulmonary exercise test (CPET)

Secondary outcomes

  1. Change in right atrial pressure (RAP) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  2. Change in right atrial pressure (RAP) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  3. Change in right ventricular pressure (RVP) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  4. Change in right ventricular pressure (RVP) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  5. Change in systolic pulmonary arterial pressure (sPAP) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  6. Change in systolic pulmonary arterial pressure (sPAP) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  7. Change in diastolic pulmonary arterial pressure (dPAP) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  8. Change in diastolic pulmonary arterial pressure (dPAP) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  9. Change in mean pulmonary arterial pressure (mPAP) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  10. Change in mean pulmonary arterial pressure (mPAP) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  11. Change in pulmonary arterial wedge pressure (PAWP) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  12. Change in pulmonary arterial wedge pressure (PAWP) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  13. Change in cardiac output (CO) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  14. Change in cardiac output (CO) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  15. Change in pulmonary vascular resistance (PVR) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  16. Change in pulmonary vascular resistance (PVR) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  17. Change in venous oxygen saturation from pulmonary artery (SvO2) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  18. Change in venous oxygen saturation from pulmonary artery (SvO2) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  19. Change in cardiac index (CI) at rest

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics at rest

  20. Change in cardiac index (CI) during exercise

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Changes in hemodynamics during exercise

  21. Change in exercise capacity assessed by six minute walking test

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Six Minute Walking distance (6MWD) in meters

  22. Change in exercise capacity - workload

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    recumbent bike (Workload in Watts) during cycle Ergometer test

  23. Change in exercise capacity - respiratory economy

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    EqO2, EqCO2 assessed during cardiopulmonary exercise testing

  24. Change of laboratory parameters of right heart function

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Measurement of NT-proBNP

  25. Change in right atrial area

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Change of cm2 of right atrial area measured by 2D echocardiography

  26. Change in right ventricular area

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    Change of cm2 of right ventricular area measured by 2D echocardiography

  27. Change in visual right heart pump function

    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

  28. Safety of early rehabilitation directly after pulmonary endarterectomy: number of adverse events and serious adverse events

    Time frame: up to 15 weeks after start of rehabilitation with exercise training

    number of adverse events and serious adverse events

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 13, 2011
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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