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Clinical Trials/NCT01394367
NCT01394367
Completed
Not Applicable

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

Heidelberg University1 site in 1 country90 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Heidelberg University
Enrollment
90
Locations
1
Primary Endpoint
Improvement of peak O2 uptake (VO2peak) under stress
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
May 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Heidelberg University

Eligibility 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in hemodynamics at rest and during exercise(up to 15 weeks)

Study Sites (1)

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