Effects of Inspiratory Muscle Training in COPD (IMTCO)

• ClinicalTrials.gov Identifier: NCT01397396
• Recruitment Status: Completed
• First Posted: July 19, 2011
• Last Update Posted: March 14, 2017
• Sponsor: KU Leuven
• Information provided by (Responsible Party): Daniel Langer, KU Leuven

Tracking Information

• First Submitted Date: July 18, 2011
• First Posted Date: July 19, 2011
• Last Update Posted Date: March 14, 2017
• Actual Study Start Date: February 2012
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 18, 2011): 6-Minute Walking Distance [ Time Frame: Baseline and 8 weeks follow-up ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Inspiratory Muscle Training in COPD
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• COPD
• Inspiratory Muscle Weakness

Intervention

Procedure: Inspiratory Muscle Training

Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max

Study Arms

• 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 *

• 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.
• Charususin 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2017): 208
• Original Estimated Enrollment (submitted: July 18, 2011): 160
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01397396
• Other Study ID Numbers: S52852
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Daniel Langer, KU Leuven
• Original Responsible Party: Rik Gosselink, PT, PhD, Katholieke Universiteit Leuven
• Current Study Sponsor: KU Leuven
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rik Gosselink, PT, PhD; KU Leuven

• PRS Account: KU Leuven
• Verification Date: March 2017