Trial document




This trial has been registered retrospectively.
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  DRKS00000009

Trial Description

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Title

Influence of NPPV on development of inspiratory muscle fatigue during submaximal ergometric load

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Influence of NPPV on development of inspiratory muscle fatigue during submaximal ergometric load

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Brief Summary in Scientific Language

Determine the influence of NPPV on development of inspiratory muscle fatigue during submaximal ergometric load

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Organizational Data

  •   DRKS00000009
  •   2008/09/05
  •   [---]*
  •   yes
  •   Approved
  •   153/06, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   UKF000899  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   J98.6 -  Disorders of diaphragm
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Interventions/Observational Groups

  •   NPPV
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   [---]*
  •   [---]*
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Primary Outcome

Blood lactate and blood gas values from the arterialized ear lobe, heart rate, PImax1.0, twitch pressures and cycling time to exhaustion.
These measurements were conducted five times on each study phase (labeled I to V): before and immediately after each HEET as well as during the recovery period

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/02/01
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

healthy, male subjects, >18 years of age

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Exclusion Criteria

any preexisting disease

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Addresses

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    • Universitätsklinikum Freiburg
    • D-79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg
    • Mr.  Dr.  Hans-Joachim  Kabitz 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr. med.  Hans-Joachim  Kabitz 
    • Hugstetter Straße 55
    • D-79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

  • [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   [---]*
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Trial Publications, Results and other Documents

  •   The Open Respiratory Medicine Journal, 2008, 2, 16-21
    1874-3064/08 2008 Bentham Science Publishers Ltd.
    Non-Invasive Ventilation Applied for Recovery from Exercise-Induced Diaphragmatic Fatigue
    Hans-Joachim Kabitz*, David Walker, Stephan Prettin, Stephan Walterspacher, Florian Sonntag,Michael Dreher and Wolfram Windisch
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* This entry means the parameter is not applicable or has not been set.