Trial document



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  DRKS00004221

Trial Description

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Title

Acute impact of inspiratory muscle training on patients with stable hypercapnic COPD

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Numerous studies have revealed that patients with chronic obstructive pulmonary disease benefit from inspiratory muscle training. However the acute impact of inspiratory muscle training on patients with chronic obstructive pulmonary disease and respiratory insufficiency (elevated levels of carbon dioxid partial pressure (PaCO2) and decresed levels of oxygen partial pressure in the blood) still remains unclear. Therefore this study aims to investigate the acute effects of a training cycle of inspiratory muscle training on carbon dioxid partial pressure, inspiratory muscle strength and oxygen saturation in patients with COPD and chronic respiratory insufficiency.

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Brief Summary in Scientific Language

Numerous studies have revealed that patients with copd benefit from inspiratory muscle training (IMT). However the acute effect of IMT in COPD patients with stable hypercapnic respiratory insufficiancy still remains unclear. Especially the question wether IMT leads to an increase in PaCO2 and a decrease of inspiratory muscle strength directly after an IMT cycle still needs to be answered.
The aim of the current study is to investigate if IMT leads to an acute change of PaCO2, oxygen saturation and inspiratory muscle strenth in 20 COPD patients with stable hypercapnic respiratory insufficiancy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004221
  •   2012/07/17
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  •   yes
  •   Approved
  •   155/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
  •   J96.11 -  [generalization J96.1: Chronic respiratory failure]
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Interventions/Observational Groups

  •   20 COPD patients with stable hypercapnic respiratory insufficiency perform a cycle of inspiratory muscle training (30 breaths). Before and after a training cycle capillary blood gas analysis and respiratory muscle function tests will be performed. After a 15 min break, another cycle of inspiratory muscle training (30 breaths) will be initiated followed by another blood gas analyses and respiratory muscle function tests. Transcutaneous CO2 is assessed during the whole protocol.
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Characteristics

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

Developement of capillary carbon dioxid partial pressure (PaCO2) after a session of inspiratory muscle training

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Secondary Outcome

Developement of twitch mouth pressure after magnetic stimulation of the phrenic nerves before and after a session of inspiratory muscle training

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/07/27
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

stable hypercapnic COPD Patients

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Exclusion Criteria

Patients with neuromuscular diseases, thoracic deformity, respiratory infections, pregnancy,
pH below 7,33

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung Pneumologie Universitätsklinik Freiburg
    • Mr.  Dr.  David  Walker 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Abteilung Pneumologie Universitätsklinikum Freiburg
    • Mr.  Dr.  David  Walker 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Abteilung Pneumologie Universitätsklinikum Freiburg
    • Mr.  Dr.  David  Walker 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Abteilung Pneumologie
    • Mr.  Dr.  David  Walker 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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