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

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ClinicalTrials.gov Identifier: NCT01218295
Recruitment Status : Unknown
Verified October 2010 by Università degli Studi di Ferrara.
Recruitment status was:  Recruiting
First Posted : October 11, 2010
Last Update Posted : October 11, 2010
Sponsor:
Information provided by:
Università degli Studi di Ferrara

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.


Condition or disease Intervention/treatment
COPD Device: Spirotiger®

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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.
Study Start Date : May 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : July 2011

Arm Intervention/treatment
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



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


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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.

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

Responsible Party: Annalisa Cogo, University of Ferrara
ClinicalTrials.gov Identifier: NCT01218295     History of Changes
Other Study ID Numbers: IMTCOPD2
First Posted: October 11, 2010    Key Record Dates
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