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

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ClinicalTrials.gov Identifier: NCT01393327
Recruitment Status : Unknown
Verified June 2015 by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University.
Recruitment status was:  Recruiting
First Posted : July 13, 2011
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University

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.

Condition or disease Intervention/treatment Phase
CTEPH Behavioral: respiratory and exercise therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Study Start Date : January 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. 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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393327


Contacts
Contact: Ekkehard Grünig, Professor +49 6221 396-8053 ekkehard.gruenig@med.uni-heidelberg.de

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

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, Heidelberg University
ClinicalTrials.gov Identifier: NCT01393327     History of Changes
Other Study ID Numbers: S-488/2009
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Keywords provided by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University:
physical training
remaining post-operative pulmonary vascular changes
right ventricular pump function
PEA