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Effects of Inspiratory Muscle Training in COPD (IMTCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01397396
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Langer, KU Leuven

Brief Summary:
The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.

Condition or disease Intervention/treatment Phase
COPD Inspiratory Muscle Weakness Procedure: Inspiratory Muscle Training Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial
Actual Study Start Date : February 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Inspiratory Muscle Training
Inspiratory Muscle Training
Procedure: Inspiratory Muscle Training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max

Placebo Comparator: Sham IMT
Sham Inspiratory Muscle Training
Procedure: Inspiratory Muscle Training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max




Primary Outcome Measures :
  1. 6-Minute Walking Distance [ Time Frame: Baseline and 8 weeks follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with COPD
  • Eligible to participate in a exercise training intervention of 8 weeks
  • Pi,max <60cmH2O or <50% of the predicted normal value

Exclusion Criteria:

  • Major comorbidities preventing successful participation in an 8 week exercise training intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397396


Locations
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Belgium
University Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Rik Gosselink, PT, PhD KU Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Langer, Dr Daniel Langer, KU Leuven
ClinicalTrials.gov Identifier: NCT01397396    
Other Study ID Numbers: S52852
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Muscle Weakness
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases