Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Università degli Studi di Ferrara.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Università degli Studi di Ferrara
Information provided by:
Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01218295
First received: October 7, 2010
Last updated: October 8, 2010
Last verified: October 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 7, 2010 | ||||||||
| Last Updated Date | October 8, 2010 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Exercise Capacity [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01218295 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD) | ||||||||
| Official Title ICMJE | Efficacy of Inspiratory Muscle Training by Means of Spirotiger® in COPD Patients. | ||||||||
| Brief Summary | Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea improves exercise tolerance in healthy subjects. No information is available about the use of this training in COPD patients even if other methods (such as threshold loading and resistive loading) have been shown to be effective in terms of Inspiratory Muscle Function, Health-Related Quality of Life and Exercise Tolerance. This study is designed to evaluate the effects of normocapnic hyperventilation by means of Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the methodology of isocapnic hyperpnoea)in COPD patients. |
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| Detailed Description | --- |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | COPD | ||||||||
| Intervention ICMJE | Device: Spirotiger®
training session :10 minutes twice a day X 4 weeks
Other Name: Pulmonary rehabilitation |
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| Study Arm (s) | Experimental: Respiratory muscle training
Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.
Intervention: Device: Spirotiger® |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2011 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01218295 | ||||||||
| Other Study ID Numbers ICMJE | IMTCOPD2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Annalisa Cogo, University of Ferrara | ||||||||
| Study Sponsor ICMJE | Università degli Studi di Ferrara | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Università degli Studi di Ferrara | ||||||||
| Verification Date | October 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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