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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01393327
Enrollment
45
Registered
2011-07-13
Start date
2010-01-31
Completion date
2013-12-31
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CTEPH

Keywords

physical training, remaining post-operative pulmonary vascular changes, right ventricular pump function, PEA

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.

Interventions

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

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEAup to 15 weeks after start of rehabilitation with exercise trainingAssessment 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 exerciseup to 15 weeks after start of rehabilitation with exercise trainingChange of peak O2 uptake measured by cardiopulmonary exercise test (CPET)

Secondary

MeasureTime frameDescription
Change in right ventricular pressure (RVP) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in right ventricular pressure (RVP) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in systolic pulmonary arterial pressure (sPAP) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in systolic pulmonary arterial pressure (sPAP) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in diastolic pulmonary arterial pressure (dPAP) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in diastolic pulmonary arterial pressure (dPAP) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in mean pulmonary arterial pressure (mPAP) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in mean pulmonary arterial pressure (mPAP) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in pulmonary arterial wedge pressure (PAWP) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in pulmonary arterial wedge pressure (PAWP) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in cardiac output (CO) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in cardiac output (CO) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in pulmonary vascular resistance (PVR) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in right atrial pressure (RAP) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in venous oxygen saturation from pulmonary artery (SvO2) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in venous oxygen saturation from pulmonary artery (SvO2) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in cardiac index (CI) at restup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics at rest
Change in cardiac index (CI) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in exercise capacity assessed by six minute walking testup to 15 weeks after start of rehabilitation with exercise trainingSix Minute Walking distance (6MWD) in meters
Change in exercise capacity - workloadup to 15 weeks after start of rehabilitation with exercise trainingrecumbent bike (Workload in Watts) during cycle Ergometer test
Change in exercise capacity - respiratory economyup to 15 weeks after start of rehabilitation with exercise trainingEqO2, EqCO2 assessed during cardiopulmonary exercise testing
Change of laboratory parameters of right heart functionup to 15 weeks after start of rehabilitation with exercise trainingMeasurement of NT-proBNP
Change in right atrial areaup to 15 weeks after start of rehabilitation with exercise trainingChange of cm2 of right atrial area measured by 2D echocardiography
Change in right ventricular areaup to 15 weeks after start of rehabilitation with exercise trainingChange of cm2 of right ventricular area measured by 2D echocardiography
Change in visual right heart pump functionup to 15 weeks after start of rehabilitation with exercise trainingChange 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 eventsup to 15 weeks after start of rehabilitation with exercise trainingnumber of adverse events and serious adverse events
Change in pulmonary vascular resistance (PVR) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise
Change in right atrial pressure (RAP) during exerciseup to 15 weeks after start of rehabilitation with exercise trainingChanges in hemodynamics during exercise

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026