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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

Tracking Information
First Submitted Date  ICMJE July 18, 2011
First Posted Date  ICMJE July 19, 2011
Last Update Posted Date March 14, 2017
Actual Study Start Date  ICMJE February 2012
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
6-Minute Walking Distance [ Time Frame: Baseline and 8 weeks follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Inspiratory Muscle Training in COPD
Official Title  ICMJE Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Inspiratory Muscle Weakness
Intervention  ICMJE Procedure: Inspiratory Muscle Training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max
Study Arms  ICMJE
  • Experimental: Inspiratory Muscle Training
    Inspiratory Muscle Training
    Intervention: Procedure: Inspiratory Muscle Training
  • Placebo Comparator: Sham IMT
    Sham Inspiratory Muscle Training
    Intervention: Procedure: Inspiratory Muscle Training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2017)
208
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2011)
160
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01397396
Other Study ID Numbers  ICMJE S52852
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Daniel Langer, KU Leuven
Original Responsible Party Rik Gosselink, PT, PhD, Katholieke Universiteit Leuven
Current Study Sponsor  ICMJE KU Leuven
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rik Gosselink, PT, PhD KU Leuven
PRS Account KU Leuven
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP