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

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, Conventional respiratory rehabilitation, Dyspnea scale

Eligibility Criteria

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

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

Sites / Locations

  • Brest University Hospital
  • Hospital of Morlaix

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard

IMT

Arm Description

conventional respiratory rehabilitation

Inspiratory muscle training and conventional respiratory rehabilitation

Outcomes

Primary Outcome Measures

Dyspnea measure
Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire

Secondary Outcome Measures

Full Information

First Posted
February 29, 2012
Last Updated
September 18, 2012
Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01545011
Brief Title
Effects of Inspiratory Muscle Training on Dyspnea in Subjects With Chronic Obstructive Pulmonary Disease
Acronym
IMT
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

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, Conventional respiratory rehabilitation, Dyspnea scale

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
standard
Arm Type
No Intervention
Arm Description
conventional respiratory rehabilitation
Arm Title
IMT
Arm Type
Experimental
Arm Description
Inspiratory muscle training and conventional respiratory 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 changes in Mutidimentionnal Dyspnea Profile result questionnaire
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Brest University Hospital
City
Brest
State/Province
Brittany
ZIP/Postal Code
29200
Country
France
Facility Name
Hospital of Morlaix
City
Morlaix
State/Province
Brittany
ZIP/Postal Code
29600
Country
France

12. IPD Sharing Statement

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

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