- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545011
Effects of Inspiratory Muscle Training on Dyspnea in Subjects With Chronic Obstructive Pulmonary Disease (IMT)
Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brittany Region
-
Brest, Brittany Region, France, 29200
- Brest University Hospital
-
Morlaix, Brittany Region, France, 29600
- Hospital of Morlaix
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: standard
conventional respiratory rehabilitation
|
|
|
Experimental: IMT
Inspiratory muscle training and conventional respiratory rehabilitation
|
Inspiratory muscle training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea measure
Time Frame: 21 days
|
Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire
|
21 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RB 11.083 (EMI)
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