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

NCT ID: NCT01393327

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

CTEPH

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Respiratory and exercise therapy

Early after PEA postoperative three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks.

Group Type: EXPERIMENTAL

respiratory and exercise therapy

Intervention Type: BEHAVIORAL

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

Interventions

respiratory and exercise therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ekkehard Grünig, Professor

Role: STUDY_DIRECTOR

Center for pulmonary hypertension, Thoraxclinic Heidelberg

Locations

Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, , Germany

Countries

Germany

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Other Identifiers

S-488/2009

Identifier Type: -

Identifier Source: org_study_id