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

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ClinicalTrials.gov Identifier: NCT01545011
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : September 19, 2012
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest

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).

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Inspiratory muscle training

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 : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial
Study Start Date : October 2011
Primary Completion Date : April 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: standard
conventional respiratory rehabilitation
Experimental: IMT
Inspiratory muscle training and conventional respiratory rehabilitation
Other: Inspiratory muscle training
Inspiratory muscle training

Primary Outcome Measures :
  1. Dyspnea measure [ Time Frame: 21 days ]
    Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545011

Brest University Hospital
Brest, Brittany, France, 29200
Hospital of Morlaix
Morlaix, Brittany, France, 29600
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01545011     History of Changes
Other Study ID Numbers: RB 11.083 (EMI)
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

Keywords provided by University Hospital, Brest:
Inspiratory muscle training
Conventional respiratory rehabilitation
Dyspnea scale

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes