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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Inspiratory muscle training, COPD, dyspnea, Multidimensional Dyspnea Profile questionnaire (MDP)., pulmonary rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre des maladies respiratoires et allergiques - Les Acacias
  • Brest University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard

Inspiratory muscle training

Arm Description

conventional pulmonary rehabilitation

Inspiratory muscle training associated with a conventional pulmonary rehabilitation

Outcomes

Primary Outcome Measures

Dyspnea measure
Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire.

Secondary Outcome Measures

PI max variation
Measure of PI max variation with MicroRPM
CI variation
Measure of CI variation with spirobank II
Dyspnea measure
Meausre of dyspnea with London Chest of Activity Daily Living (LCADL)

Full Information

First Posted
February 27, 2014
Last Updated
October 24, 2016
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02074813
Brief Title
Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD
Acronym
EMI II
Official Title
Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Inspiratory muscle training, COPD, dyspnea, Multidimensional Dyspnea Profile questionnaire (MDP)., pulmonary rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm Description
conventional pulmonary rehabilitation
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training associated with a conventional pulmonary rehabilitation
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Inspiratory muscle training
Primary Outcome Measure Information:
Title
Dyspnea measure
Description
Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire.
Time Frame
21 - 4 days / +7 jours
Secondary Outcome Measure Information:
Title
PI max variation
Description
Measure of PI max variation with MicroRPM
Time Frame
21 - 4 days / +7 days
Title
CI variation
Description
Measure of CI variation with spirobank II
Time Frame
21 - 4 days / +7 days
Title
Dyspnea measure
Description
Meausre of dyspnea with London Chest of Activity Daily Living (LCADL)
Time Frame
21 - 4 days / +7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre des maladies respiratoires et allergiques - Les Acacias
City
Briançon
ZIP/Postal Code
05107
Country
France
Facility Name
Brest University Hospital
City
Morlaix
ZIP/Postal Code
29672
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29371379
Citation
Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
Results Reference
derived

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Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD

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