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
Sponsor:
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Inspiratory Muscle Training by Means of Spirotiger® in COPD Patients.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Exercise Capacity [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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

Detailed Description:

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  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Annalisa Cogo, University of Ferrara
ClinicalTrials.gov Identifier: NCT01218295     History of Changes
Other Study ID Numbers: IMTCOPD2
Study First Received: October 7, 2010
Last Updated: October 8, 2010
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Respiratory Aspiration
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014