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

COPD Clinical Trial

Official title:

Efficacy of Inspiratory Muscle Training by Means of Spirotiger® in COPD Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01218295
• Other study ID #: IMTCOPD2
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2010
• Last updated: October 8, 2010
• Start date: May 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2010
• Source: Università degli Studi di Ferrara
• Contact: Annalisa Cogo, MD
• Phone: +390532210420
• Email: cga[@]unife.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Device:
• Spirotiger®
training session :10 minutes twice a day X 4 weeks

Locations

Country	Name	City	State
Italy	Pulmonary Respiratory Unit- University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Capacity		1 month	No