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History of Changes for Study: NCT01397396
Effects of Inspiratory Muscle Training in COPD (IMTCO)
Latest version (submitted March 12, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 18, 2011 None (earliest Version on record)
2 February 8, 2012 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
3 August 9, 2012 Study Status and Contacts/Locations
4 June 26, 2013 Study Status and Arms and Interventions
5 April 11, 2014 Study Status
6 February 2, 2015 Study Status
7 February 1, 2016 Study Status
8 January 12, 2017 Study Status
9 March 12, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01397396
Submitted Date:  July 18, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: S52852
Brief Title: Effects of Inspiratory Muscle Training in COPD (IMTCO)
Official Title: Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2011
Overall Status: Not yet recruiting
Study Start: September 2011
Primary Completion: September 2014 [Anticipated]
Study Completion: December 2014 [Anticipated]
First Submitted: July 18, 2011
First Submitted that
Met QC Criteria:
July 18, 2011
First Posted: July 19, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 18, 2011
Last Update Posted: July 19, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: KU Leuven
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: COPD
Inspiratory Muscle Weakness
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 160 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 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 Procedure: Inspiratory Muscle Training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 6-Minute Walking Distance
[ Time Frame: Baseline and 8 weeks follow-up ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Daniel Langer, PT, PhD
Telephone: 0032-16-330192
Email: daniel.langer@faber.kuleuven.be
Locations: Belgium
University Hospital Leuven
Leuven, Belgium, 3000
Contact:Contact: Daniel Langer, PT, PhD 0032-16-330192 daniel.langer@faber.kuleuven.be
Contact:Principal Investigator: Rik Gosselink, PT, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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