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Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD (EMI II)

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ClinicalTrials.gov Identifier: NCT02074813
Recruitment Status : Completed
First Posted : February 28, 2014
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Inspiratory muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial
Study Start Date : March 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard
conventional pulmonary rehabilitation
Experimental: Inspiratory muscle training
Inspiratory muscle training associated with a conventional pulmonary rehabilitation
Other: Inspiratory muscle training
Inspiratory muscle training




Primary Outcome Measures :
  1. Dyspnea measure [ Time Frame: 21 - 4 days / +7 jours ]
    Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire.


Secondary Outcome Measures :
  1. PI max variation [ Time Frame: 21 - 4 days / +7 days ]
    Measure of PI max variation with MicroRPM

  2. CI variation [ Time Frame: 21 - 4 days / +7 days ]
    Measure of CI variation with spirobank II

  3. Dyspnea measure [ Time Frame: 21 - 4 days / +7 days ]
    Meausre of dyspnea with London Chest of Activity Daily Living (LCADL)



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

Inclusion Criteria:

  • Patients with COPD stage 3 or 4
  • Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course;

Exclusion Criteria:

  • FEV ≥ 50%
  • Pneumonectomy, Lobectomy less than 6 months
  • Patient with risk of spontaneous pneumothorax or rib fracture

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): NCT02074813


Locations
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France
Centre des maladies respiratoires et allergiques - Les Acacias
Briançon, France, 05107
Brest University Hospital
Morlaix, France, 29672
Sponsors and Collaborators
University Hospital, Brest

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02074813     History of Changes
Other Study ID Numbers: EMI II (RB 13.124)
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by University Hospital, Brest:
Inspiratory muscle training
COPD
dyspnea
Multidimensional Dyspnea Profile questionnaire (MDP).
pulmonary rehabilitation

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