Effects of Inspiratory Muscle Training on Dyspnea in Subjects With Chronic Obstructive Pulmonary Disease (IMT)

This study has been completed.

Sponsor:

Collaborator:

Ministry of Health, France

Information provided by (Responsible Party):

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT01545011

First received: February 29, 2012

Last updated: September 18, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 29, 2012
Last Updated Date	September 18, 2012
Start Date ^ICMJE	October 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 5, 2012)	Dyspnea measure [ Time Frame: 21 days ] [ Designated as safety issue: No ] Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01545011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Inspiratory Muscle Training on Dyspnea in Subjects With Chronic Obstructive Pulmonary Disease
Official Title ^ICMJE	Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial
Brief Summary	The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).
Detailed Description	Dyspnea is the main complaint of patients with COPD. Dyspnea is explained largely by the distension, objectified by measuring inspiratory capacity (IC), which places the diaphragm at a disadvantage to be effective, which raises the sensation of dyspnea. Currently, inspiratory muscles training is recommended by the French-language Society of Pneumology, in case of an objective reduction of the strength of these muscles (corresponding to maximum inspiratory pressure <60 cm H20).
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE	Other: Inspiratory muscle training Inspiratory muscle training
Study Arm (s)	No Intervention: standard conventional respiratory rehabilitation Experimental: IMT Inspiratory muscle training and conventional respiratory rehabilitation Intervention: Other: Inspiratory muscle training
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	38
Completion Date	September 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient with COPD Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course Exclusion Criteria: Pneumonectomy, Lobectomy less than 6 months Cardio-pulmonary anomaly Max inspiratory pressure < 60 cm H2O
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01545011
Other Study ID Numbers ^ICMJE	RB 11.083 (EMI)
Has Data Monitoring Committee	No
Responsible Party	University Hospital, Brest
Study Sponsor ^ICMJE	University Hospital, Brest
Collaborators ^ICMJE	Ministry of Health, France
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Brest
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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