Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— EMI II  

Official title:

Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074813
• Other study ID #: EMI II (RB 13.124)
• Status: Completed
• Phase: N/A
• First received: February 27, 2014
• Last updated: October 24, 2016
• Start date: March 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - Agence Nationale de Sécurité du Médicament (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Other:
• Inspiratory muscle training
Inspiratory muscle training

Locations

Country	Name	City	State
France	Centre des maladies respiratoires et allergiques - Les Acacias	Briançon
France	Brest University Hospital	Morlaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea measure	Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire.	21 - 4 days / +7 jours	No
Secondary	PI max variation	Measure of PI max variation with MicroRPM	21 - 4 days / +7 days	No
Secondary	CI variation	Measure of CI variation with spirobank II	21 - 4 days / +7 days	No
Secondary	Dyspnea measure	Meausre of dyspnea with London Chest of Activity Daily Living (LCADL)	21 - 4 days / +7 days	No