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

This study is currently recruiting participants.
Verified July 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01398345
First received: July 19, 2011
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

Background

—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.

Methods

—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.

Prospects

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


Condition Intervention Phase
Chronic Pulmonary Hypertension
 Behavioral: Exercise and Respiratory Training
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • distance walked in 6 minutes [ Time Frame: baseline - 15 weeks afterwards ] [ Designated as safety issue: No ]
  • change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire [ Time Frame: baseline - 15 weeks afterwards ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in WHO functional classification [ Time Frame: baseline - 15 weeks afterwards ] [ Designated as safety issue: No ]
  • Borg scale assessed immediately after completion of the stress Doppler echocardiography [ Time Frame: baseline - 15 weeks afterwards ] [ Designated as safety issue: No ]
  • parameters of echocardiography [ Time Frame: baseline - 15 weeks afterwards ] [ Designated as safety issue: No ]
  • parameters of gas exchange [ Time Frame: baseline - 15 weeks afterwards ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2003
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398345

Contacts
Contact: Ekkehard Gruenig, Prof.; MD +49 (0) 6221 396 8053 ekkehard.gruenig@thoraxklinik-heidelberg.de

Locations
Germany
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Ekkehard Gruenig, Prof.; MD     +49 (0) 6221 396 8053     ekkehard.gruenig@thoraxklinik-heidelberg.de    
Sponsors and Collaborators
University of Heidelberg
  More Information

No publications provided by University of Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01398345     History of Changes
Other Study ID Numbers: 364/2003
Study First Received: July 19, 2011
Last Updated: July 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 19, 2013