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NCT01545011 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01545011
Other study ID # RB 11.083 (EMI)
Secondary ID
Status Completed
Phase N/A
First received February 29, 2012
Last updated September 18, 2012
Start date October 2011
Est. completion date September 2012

Study information
Verified date September 2012
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Other:
• Inspiratory muscle training
Inspiratory muscle training

Locations
Country Name City State
France Brest University Hospital Brest Brittany
France Hospital of Morlaix Morlaix Brittany

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Brest Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dyspnea measure Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire 21 days No
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