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Effects of Inspiratory Muscle Training in COPD (IMTCO)

Primary Purpose

COPD, Inspiratory Muscle Weakness

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Inspiratory Muscle Training

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory Muscle Training

Sham IMT

Arm Description

Inspiratory Muscle Training

Sham Inspiratory Muscle Training

Outcomes

Primary Outcome Measures

6-Minute Walking Distance

Secondary Outcome Measures

Full Information

NCT ID

NCT01397396

First Posted

July 18, 2011

Last Updated

March 12, 2017

Sponsor

KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT01397396

Brief Title

Effects of Inspiratory Muscle Training in COPD

Acronym

IMTCO

Official Title

Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2012 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Inspiratory Muscle Weakness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inspiratory Muscle Training

Arm Type

Experimental

Arm Description

Inspiratory Muscle Training

Arm Title

Sham IMT

Arm Type

Placebo Comparator

Arm Description

Sham Inspiratory Muscle Training

Intervention Type

Procedure

Intervention Name(s)

Inspiratory Muscle Training

Intervention Description

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

Primary Outcome Measure Information:

Title

6-Minute Walking Distance

Time Frame

Baseline and 8 weeks follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rik Gosselink, PT, PhD

Organizational Affiliation

KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

29914940

Citation

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.

Results Reference

derived

PubMed Identifier

23921069

Citation

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.

Results Reference

derived

Learn more about this trial

Effects of Inspiratory Muscle Training in COPD

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