Trial document
DRKS00004221
Trial Description
Title
Acute impact of inspiratory muscle training on patients with stable hypercapnic COPD
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.
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.
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
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]
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.
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
Primary Outcome
Developement of capillary carbon dioxid partial pressure (PaCO2) after a session of inspiratory muscle training
Secondary Outcome
Developement of twitch mouth pressure after magnetic stimulation of the phrenic nerves before and after a session of inspiratory muscle training
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2012/07/27
- 20
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
stable hypercapnic COPD Patients
Exclusion Criteria
Patients with neuromuscular diseases, thoracic deformity, respiratory infections, pregnancy,
pH below 7,33
Addresses
-
start of 1:1-Block address primary-sponsor
- Abteilung Pneumologie Universitätsklinik Freiburg
- Mr. Dr. David Walker
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0761 270 37060
- 0761 270 74070
- david.walker at uniklinik-freiburg.de
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Abteilung Pneumologie Universitätsklinikum Freiburg
- Mr. Dr. David Walker
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 076127037060
- 076127074070
- david.walker at uniklnik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Abteilung Pneumologie Universitätsklinikum Freiburg
- Mr. Dr. David Walker
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 076127037060
- 076127074070
- david.walker at uniklnik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- http://www.dfg.de
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- Abteilung Pneumologie
- Mr. Dr. David Walker
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- 076127037060
- 076127074070
- david.walker at uniklnik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact otherSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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