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Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

This study is currently recruiting participants.
Verified March 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01394367
First received: June 28, 2011
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change 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
Pulmonary Hypertension
 Other: 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: Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

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: up to 15 weeks ] [ Designated as safety issue: No ]
    Three-week inpatient rehabilitation, continuation of the training program for another 12 weeks at home (exercise group), patients in the control group continued their usual activities. After 15 weeks, training is also offered to patients in the control group.


Secondary Outcome Measures:
  • Changes in hemodynamics at rest and during exercise [ 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: June 2010
Estimated Study Completion Date: June 2013
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 three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group.
 Other: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consent form
  • men and women> 18 years <75 years
  • invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable.

Exclusion Criteria:

  • Pregnancy or lactation
  • Change in medication during the last 2 months
  • Patients with signs of right heart decompensation
  • severe walking disturbance
  • uncertain diagnoses
  • No previous invasively confirmation of PH
  • acute diseases, infections, fever
  • Serious lung disease with FEV1 <50% or TLC <70% of target
  • Further 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: NCT01394367

Contacts
Contact: Ekkehard Grünig, Professor +49 6221 396-8053 ekkehard.gruenig@thoraxklinik-heidelberg.de
Contact: Nicola Ehlken, BSc +49 6221 396-8076 nicola.ehlken@thoraxklinik-heidelberg.de

Locations
Germany
Center for pulmonary Hypertension, Thoraxclinic Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Ekkehard Grünig, Professor     +49 6221 396 8053     ekkehard.gruenig@thoraxklinik-heidelberg.de    
Contact: Nicola Ehlken, BSc     +49 6221 396 8076     nicola.ehlken@thoraxklinik-heidelberg.de    
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: NCT01394367     History of Changes
Other Study ID Numbers: S-472/2009
Study First Received: June 28, 2011
Last Updated: March 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
respiratory therapy
exercise therapy
oxygen uptake
 quality of life
right ventricular function
severe pulmonary hypertension

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

ClinicalTrials.gov processed this record on May 22, 2013