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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01545011
First received: February 29, 2012
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Other: Inspiratory muscle training

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Dyspnea measure [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire


Enrollment: 38
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard
conventional respiratory rehabilitation
Experimental: IMT
Inspiratory muscle training and conventional respiratory rehabilitation
 Other: Inspiratory muscle training
Inspiratory muscle training

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545011

Locations
France
Brest University Hospital
Brest, Brittany, France, 29200
Hospital of Morlaix
Morlaix, Brittany, France, 29600
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01545011     History of Changes
Other Study ID Numbers: RB 11.083 (EMI)
Study First Received: February 29, 2012
Last Updated: September 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Inspiratory muscle training
COPD
Conventional respiratory rehabilitation
Dyspnea scale

Additional relevant MeSH terms:
Respiratory Aspiration
Dyspnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013