Effects of Inspiratory Muscle Training in COPD (IMTCO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Daniel Langer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01397396
First received: July 18, 2011
Last updated: February 2, 2015
Last verified: February 2015
  Purpose

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 Intervention Phase
COPD
Inspiratory Muscle Weakness
Procedure: Inspiratory Muscle Training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 6-Minute Walking Distance [ Time Frame: Baseline and 8 weeks follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397396

Contacts
Contact: Daniel Langer, PT, PhD 0032-16-330192 daniel.langer@faber.kuleuven.be

Locations
Belgium
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: Daniel Langer, PT, PhD    0032-16-330192    daniel.langer@faber.kuleuven.be   
Principal Investigator: Rik Gosselink, PT, PhD         
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Rik Gosselink, PT, PhD Katholieke Universiteit Leuven
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel Langer, Dr Daniel Langer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01397396     History of Changes
Other Study ID Numbers: S52852
Study First Received: July 18, 2011
Last Updated: February 2, 2015
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Respiratory Aspiration
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 26, 2015