Inspiratory Muscle Training With Normocapnic Hyperpnea in... | NCT01218295

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

NCT01218295

Sponsor

Università degli Studi di Ferrara

Status

Unknown status

Last Update Posted

Oct 11, 2010Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

COPD

Interventions

Spirotiger®

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2011Estimated

Completion Date

Jul 2011Estimated

First Submitted Date

Oct 7, 2010

First Submission Date that Met QC Criteria

Oct 8, 2010

First Posted Date

Oct 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2010

Last Update Posted Date

Oct 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Respiratory muscle training	Experimental	Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.	Device: Spirotiger®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spirotiger®	Device	training session :10 minutes twice a day X 4 weeks	Respiratory muscle training

Measure	Description	Time Frame
Exercise Capacity		1 month

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Annalisa Cogo, MD	Contact	+390532210420		cga@unife.it
Luca Pomidori, PhD	Contact	+390532455888		pmdlcu@unife.it

Overall Officials

Name	Affiliation	Role
Annalisa Cogo, MD	Università di Ferrara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Respiratory Unit- University Hospital	Recruiting	Ferrara	Ferrara	44100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided