Trial document




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  DRKS00003567

Trial Description

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Title

Respiratory muscle function in pulmonary hypertension

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study aims at assessing respiratory muscle strength in patients with idiopathic pulmonary hypertension (DanaPoint class I) undergoing a 3 week stationary rehabilitation. Previous studies already proved the existence of respiratory muscle affection and subsequent limitations in exercise. It is hypothesized that stationary rehabilitation not only improves general exercise performance in these patients, but also leads to increased respiratory muscle strength. Therefore, 7 patients undergoing a structured 3 week stationary rehabilitation program will be measured assessing lung function parameters and indices of respiratory muscle strength prior and post rehabilitation.

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Brief Summary in Scientific Language

This study aims at assessing respiratory muscle strength in patients with idiopathic pulmonary hypertension (DanaPoint class I) undergoing a 3 week stationary rehabilitation. Previous studies already proved the existence of respiratory muscle affection and subsequent limitations in exercise. It is hypothesized that stationary rehabilitation not only improves general exercise performance in these patients, but also leads to increased respiratory muscle strength. Therefore, 7 patients undergoing a structured 3 week stationary rehabilitation program will be measured assessing lung function parameters and indices of respiratory muscle strength prior and post rehabilitation.

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Organizational Data

  •   DRKS00003567
  •   2012/02/27
  •   2006/09/05
  •   yes
  •   Approved
  •   93/06, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1128-2755 
  •   UKF000758  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   I27.0 -  Primary pulmonary hypertension
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Interventions/Observational Groups

  •   Prior and post 3 week rehabilitation the following measurements will be performed:
    Tests of respiratory muscle strength
    Lung function
    Blood gas analysis
    Six minute walking test with assessment of walking distance and dyspnea ratings.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
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Primary Outcome

Evaluation of respiratory muscle strength at the beginning and after three weeks of stationary rehabilitation.

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Secondary Outcome

Secondary endpoints following rehabilitation are:
Increase in lung function parameters
Inrease in blood gas parameters (oxygenation)
Increase in walking distance
Improvement of dyspnea ratings.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2007/02/01
  •   7
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Established diagnosis of pulmonary hypertension (Dana Point class I) (NYHA class III-IV) and treatment in an established center according to current recommendations.

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Exclusion Criteria

Other forms of pulmonary hypertension that are not covered in Dana Point class I
rib cage abnormalities
neuromuscular disorders
systemic steroid therapy
diabetes
cachexia

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  PD Dr.  Hans-Joachim  Kabitz 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  PD Dr.  Hans-Joachim  Kabitz 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  PD Dr.  Hans-Joachim  Kabitz 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  PD Dr.  Hans-Joachim  Kabitz 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2009/11/27
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.