Effects of Inspiratory Muscle Training in COPD
IMTCO
1 other identifier
interventional
208
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2012
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 14, 2017
March 1, 2017
4.8 years
July 18, 2011
March 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
6-Minute Walking Distance
Baseline and 8 weeks follow-up
Study Arms (2)
Inspiratory Muscle Training
EXPERIMENTALInspiratory Muscle Training
Sham IMT
PLACEBO COMPARATORSham Inspiratory Muscle Training
Interventions
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of \>50% Pi,max
Eligibility Criteria
You may qualify if:
- Patients with COPD
- Eligible to participate in a exercise training intervention of 8 weeks
- Pi,max \<60cmH2O or \<50% of the predicted normal value
You may not qualify if:
- Major comorbidities preventing successful participation in an 8 week exercise training intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
University Hospital Leuven
Leuven, 3000, Belgium
Related Publications (2)
Charususin N, Gosselink R, Decramer M, Demeyer H, McConnell A, Saey D, Maltais F, Derom E, Vermeersch S, Heijdra YF, van Helvoort H, Garms L, Schneeberger T, Kenn K, Gloeckl R, Langer D. Randomised controlled trial of adjunctive inspiratory muscle training for patients with COPD. Thorax. 2018 Oct;73(10):942-950. doi: 10.1136/thoraxjnl-2017-211417. Epub 2018 Jun 18.
PMID: 29914940DERIVEDCharususin N, Gosselink R, Decramer M, McConnell A, Saey D, Maltais F, Derom E, Vermeersch S, van Helvoort H, Heijdra Y, Klaassen M, Glockl R, Kenn K, Langer D. Inspiratory muscle training protocol for patients with chronic obstructive pulmonary disease (IMTCO study): a multicentre randomised controlled trial. BMJ Open. 2013 Aug 5;3(8):e003101. doi: 10.1136/bmjopen-2013-003101.
PMID: 23921069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rik Gosselink, PT, PhD
KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Daniel Langer
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 19, 2011
Study Start
February 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 14, 2017
Record last verified: 2017-03