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

NCT ID: NCT01218295

Last Updated: 2010-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Respiratory muscle training

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

Group Type EXPERIMENTAL

Spirotiger®

Intervention Type DEVICE

training session :10 minutes twice a day X 4 weeks

Interventions

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Spirotiger®

training session :10 minutes twice a day X 4 weeks

Intervention Type DEVICE

Other Intervention Names

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Pulmonary rehabilitation

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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University of Ferrara

Principal Investigators

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Annalisa Cogo, MD

Role: PRINCIPAL_INVESTIGATOR

Università di Ferrara

Locations

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Pulmonary Respiratory Unit- University Hospital

Ferrara, Ferrara, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Annalisa Cogo, MD

Role: CONTACT

[email protected]
+390532210420

Luca Pomidori, PhD

Role: CONTACT

[email protected]
+390532455888

Facility Contacts

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Annalisa Cogo, MD

Role: primary

[email protected]
+390532210420

Luca Pomidori, PhD

Role: backup

[email protected]
+390532455888

Other Identifiers

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IMTCOPD2

Identifier Type: -

Identifier Source: org_study_id