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Exercise and Respiratory Training as Supportive Treatments for Patients With Chronic Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01398345
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : July 2, 2014
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University

Brief Summary:


—Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.


—Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.


—We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.

Condition or disease Intervention/treatment Phase
Chronic Pulmonary Hypertension Behavioral: Exercise and Respiratory Training Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension
Study Start Date : April 2003
Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Exercise and Respiratory Training Behavioral: Exercise and Respiratory Training
Patients in the interventional group will participate in an exercise program 7 days a week at low workloads (10 to 60 W) that will be supervised by physical therapists and physicians.

Primary Outcome Measures :
  1. distance walked in 6 minutes [ Time Frame: baseline - 15 weeks afterwards ]
  2. change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire [ Time Frame: baseline - 15 weeks afterwards ]

Secondary Outcome Measures :
  1. changes in WHO functional classification [ Time Frame: baseline - 15 weeks afterwards ]
  2. Borg scale assessed immediately after completion of the stress Doppler echocardiography [ Time Frame: baseline - 15 weeks afterwards ]
  3. parameters of echocardiography [ Time Frame: baseline - 15 weeks afterwards ]
  4. parameters of gas exchange [ Time Frame: baseline - 15 weeks afterwards ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with severe chronic PH who were stable and compensated under optimized medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study will be invited to participate.

Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.

Exclusion Criteria:

  • Patients with recent syncope or skeletal or muscle abnormalities prohibiting participation in an exercise program won't be included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398345

Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
Sponsors and Collaborators
Heidelberg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, Heidelberg University
ClinicalTrials.gov Identifier: NCT01398345     History of Changes
Other Study ID Numbers: 364/2003
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: July 2014

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