We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 July 2014 by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394367
First Posted: July 14, 2011
Last Update Posted: July 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
June 28, 2011
July 14, 2011
July 2, 2014
June 2010
December 2015   (Final data collection date for primary outcome measure)
Improvement of peak O2 uptake (VO2peak) under stress [ Time Frame: up to 15 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01394367 on ClinicalTrials.gov Archive Site
Changes in hemodynamics at rest and during exercise [ 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
Same as current
Not Provided
Not Provided
 
Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Pulmonary Hypertension
Other: respiratory and exercise therapy
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
  • 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.
    Intervention: Other: respiratory and exercise therapy
  • No Intervention: respiratory and exercise therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
90
June 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01394367
S-472/2009
No
Not Provided
Not Provided
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
Heidelberg University
Not Provided
Study Director: Ekkehard Grünig, Professor Center for pulmonary hypertension, Thoraxclinic Heidelberg
Heidelberg University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP