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

CTEPH Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393327
• Other study ID #: S-488/2009
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2021
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• CTEPH

Intervention

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

Locations

Country	Name	City	State
Germany	Center for pulmonary Hypertension, Thoraxclinic Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (28)

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Grünig E, Biskupek J, D'Andrea A, Ehlken N, Egenlauf B, Weidenhammer J, Marra AM, Cittadini A, Fischer C, Bossone E. Reference ranges for and determinants of right ventricular area in healthy adults by two-dimensional echocardiography. Respiration. 2015;8 — View Citation

Grünig E, Henn P, D'Andrea A, Claussen M, Ehlken N, Maier F, Naeije R, Nagel C, Prange F, Weidenhammer J, Fischer C, Bossone E. Reference values for and determinants of right atrial area in healthy adults by 2-dimensional echocardiography. Circ Cardiovasc — View Citation

Grünig E, Lichtblau M, Ehlken N, Ghofrani HA, Reichenberger F, Staehler G, Halank M, Fischer C, Seyfarth HJ, Klose H, Meyer A, Sorichter S, Wilkens H, Rosenkranz S, Opitz C, Leuchte H, Karger G, Speich R, Nagel C. Safety and efficacy of exercise training — View Citation

Guth S, Wiedenroth CB, Rieth A, Richter MJ, Gruenig E, Ghofrani HA, Arlt M, Liebetrau C, Prüfer D, Rolf A, Hamm CW, Mayer E. Exercise right heart catheterisation before and after pulmonary endarterectomy in patients with chronic thromboembolic disease. Eu — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA	Assessment of feasibility and tolerance of exercise rehabilitation directly after PEA assessed by the number of patients completing the exercise rehabilitation program	up to 15 weeks after start of rehabilitation with exercise training
Primary	Change of peak O2 uptake (VO2peak) during exercise	Change of peak O2 uptake measured by cardiopulmonary exercise test (CPET)	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in right atrial pressure (RAP) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in right atrial pressure (RAP) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in right ventricular pressure (RVP) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in right ventricular pressure (RVP) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in systolic pulmonary arterial pressure (sPAP) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in systolic pulmonary arterial pressure (sPAP) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in diastolic pulmonary arterial pressure (dPAP) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in diastolic pulmonary arterial pressure (dPAP) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in mean pulmonary arterial pressure (mPAP) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in mean pulmonary arterial pressure (mPAP) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in pulmonary arterial wedge pressure (PAWP) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in pulmonary arterial wedge pressure (PAWP) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in cardiac output (CO) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in cardiac output (CO) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in pulmonary vascular resistance (PVR) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in pulmonary vascular resistance (PVR) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in venous oxygen saturation from pulmonary artery (SvO2) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in venous oxygen saturation from pulmonary artery (SvO2) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in cardiac index (CI) at rest	Changes in hemodynamics at rest	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in cardiac index (CI) during exercise	Changes in hemodynamics during exercise	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in exercise capacity assessed by six minute walking test	Six Minute Walking distance (6MWD) in meters	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in exercise capacity - workload	recumbent bike (Workload in Watts) during cycle Ergometer test	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in exercise capacity - respiratory economy	EqO2, EqCO2 assessed during cardiopulmonary exercise testing	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change of laboratory parameters of right heart function	Measurement of NT-proBNP	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in right atrial area	Change of cm2 of right atrial area measured by 2D echocardiography	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in right ventricular area	Change of cm2 of right ventricular area measured by 2D echocardiography	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Change in visual right heart pump function	Change of category of right heart pump function (no impairment, slight impairment, moderate impairment, severe impairment) measured by 2D echocardiography	up to 15 weeks after start of rehabilitation with exercise training
Secondary	Safety of early rehabilitation directly after pulmonary endarterectomy: number of adverse events and serious adverse events	number of adverse events and serious adverse events	up to 15 weeks after start of rehabilitation with exercise training