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

Primary Purpose

COPD

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Spirotiger®

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, inspiratory muscles training

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pulmonary Respiratory Unit- University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Respiratory muscle training

Arm Description

Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.

Outcomes

Primary Outcome Measures

Exercise Capacity

Secondary Outcome Measures

Full Information

NCT ID

NCT01218295

First Posted

October 7, 2010

Last Updated

October 8, 2010

Sponsor

Università degli Studi di Ferrara

1. Study Identification

Unique Protocol Identification Number

NCT01218295

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

June 2011 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Università degli Studi di Ferrara

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD

Keywords

COPD, inspiratory muscles training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Respiratory muscle training

Arm Type

Experimental

Arm Description

Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.

Intervention Type

Device

Intervention Name(s)

Spirotiger®

Other Intervention Name(s)

Pulmonary rehabilitation

Intervention Description

training session :10 minutes twice a day X 4 weeks

Primary Outcome Measure Information:

Title

Exercise Capacity

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Annalisa Cogo, MD

Phone

+390532210420

cga@unife.it

First Name & Middle Initial & Last Name or Official Title & Degree

Luca Pomidori, PhD

Phone

+390532455888

pmdlcu@unife.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annalisa Cogo, MD

Organizational Affiliation

Università di Ferrara

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pulmonary Respiratory Unit- University Hospital

City

Ferrara

ZIP/Postal Code

44100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annalisa Cogo, MD

Phone

+390532210420

cga@unife.it

First Name & Middle Initial & Last Name & Degree

Luca Pomidori, PhD

Phone

+390532455888

pmdlcu@unife.it

12. IPD Sharing Statement

Learn more about this trial

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

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