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Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Università degli Studi di Ferrara.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01218295
First Posted: October 11, 2010
Last Update Posted: October 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Università degli Studi di Ferrara
  Purpose

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.


Condition Intervention
COPD Device: Spirotiger®

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Inspiratory Muscle Training by Means of Spirotiger® in COPD Patients.

Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • Exercise Capacity [ Time Frame: 1 month ]

Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Respiratory muscle training
Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.
Device: Spirotiger®
training session :10 minutes twice a day X 4 weeks
Other Name: Pulmonary rehabilitation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.

Exclusion Criteria:

  • COPD patients with a recent history of cardiovascular disease, neurologic disease and other diseases that would interfere with the training.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218295


Contacts
Contact: Annalisa Cogo, MD +390532210420 cga@unife.it
Contact: Luca Pomidori, PhD +390532455888 pmdlcu@unife.it

Locations
Italy
Pulmonary Respiratory Unit- University Hospital Recruiting
Ferrara, Italy, 44100
Contact: Annalisa Cogo, MD    +390532210420    cga@unife.it   
Contact: Luca Pomidori, PhD    +390532455888    pmdlcu@unife.it   
Sponsors and Collaborators
Università degli Studi di Ferrara
Investigators
Principal Investigator: Annalisa Cogo, MD Università di Ferrara
  More Information

Responsible Party: Annalisa Cogo, University of Ferrara
ClinicalTrials.gov Identifier: NCT01218295     History of Changes
Other Study ID Numbers: IMTCOPD2
First Submitted: October 7, 2010
First Posted: October 11, 2010
Last Update Posted: October 11, 2010
Last Verified: October 2010

Keywords provided by Università degli Studi di Ferrara:
COPD
inspiratory muscles training

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes