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

October 8, 2010 updated by: Università degli Studi di Ferrara

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44100
        • Recruiting
        • Pulmonary Respiratory Unit- University Hospital
        • Contact:
          • Annalisa Cogo, MD
          • Phone Number: +390532210420
          • Email: cga@unife.it
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise Capacity
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Investigators

  • Principal Investigator: Annalisa Cogo, MD, Università di Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

October 11, 2010

Last Update Submitted That Met QC Criteria

October 8, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMTCOPD2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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