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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 Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01394367
First received: June 28, 2011
Last updated: July 1, 2014
Last verified: July 2014
  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:


Further study details as provided by Heidelberg University:

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 2016
Estimated Primary Completion Date: December 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394367

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

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, Heidelberg University
ClinicalTrials.gov Identifier: NCT01394367     History of Changes
Other Study ID Numbers: S-472/2009 
Study First Received: June 28, 2011
Last Updated: July 1, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
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 December 09, 2016