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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University Identifier:
First received: June 28, 2011
Last updated: June 19, 2015
Last verified: June 2015
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.

Condition Intervention Phase
CTEPH Behavioral: respiratory and exercise therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Heart Function in Chronic Thromboembolic Pulmonary Hypertension After Thromboendarterectomy

Resource links provided by NLM:

Further study details as provided by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University:

Primary Outcome Measures:
  • Improvement of peak O2 uptake (VO2peak) under stress [ Time Frame: 15 weeks ]

Secondary Outcome Measures:
  • Changes in hemodynamics [ Time Frame: up to 15 weeks ]
    1. Changes in hemodynamics at rest and during exercise after three weeks and 15 weeks: RAP, RVP, sPAP, DPAP, mPAP, PCWP, cardiac output, PVR, CI, SvO2
    2. Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2)
    3. Improved condition(NYHA class, Borg scale)
    4. Changes in MRI and echocardiographic parameters of right and left ventricle: size and pump function.
    5. Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins

Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Respiratory and exercise therapy
Randomized, prospective, controlled, blinded study of postoperative three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional postoperative rehabilitation without a specific training program.
Behavioral: respiratory and exercise therapy
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
No Intervention: no respiratory and exercise therapy
continuation of usual lifestyle


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Consent form
  • men and women> 18 years <80 years
  • CTEPH after thromboendarterectomy

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01393327

Contact: Ekkehard Grünig, Professor +49 6221 396-8053

Center for pulmonary Hypertension, Thoraxclinic Heidelberg Recruiting
Heidelberg, Germany, 69126
Principal Investigator: Ekkehard Grünig, Professor         
Sponsors and Collaborators
Heidelberg University
Study Director: Ekkehard Grünig, Professor Center for pulmonary hypertension, Thoraxclinic Heidelberg
  More Information

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, Heidelberg University Identifier: NCT01393327     History of Changes
Other Study ID Numbers: S-488/2009
Study First Received: June 28, 2011
Last Updated: June 19, 2015

Keywords provided by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University:
physical training
remaining post-operative pulmonary vascular changes
right ventricular pump function
PEA processed this record on August 22, 2017