Text Size

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

This study is currently recruiting participants.
Verified July 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01393327
First received: June 28, 2011
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

Purpose of this study is to investigate whether and to what extent a cautious breath 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Improvement of peak O2 uptake (VO2peak) under stress [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in hemodynamics [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
    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 2012
Estimated Primary Completion Date: December 2012 (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: respiratory and exercise therapy Behavioral: respiratory and exercise therapy
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393327

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

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

No publications provided

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01393327     History of Changes
Other Study ID Numbers: S-488/2009
Study First Received: June 28, 2011
Last Updated: July 2, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
physical training
remaining post-operative pulmonary vascular changes
right ventricular pump function
PEA

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013