Effects of Inspiratory Muscle Training in COPD

NCT ID: NCT01397396

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Inspiratory Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inspiratory Muscle Training

Inspiratory Muscle Training

Group Type EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type PROCEDURE

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

Sham IMT

Sham Inspiratory Muscle Training

Group Type PLACEBO_COMPARATOR

Inspiratory Muscle Training

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inspiratory Muscle Training

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Langer

Dr Daniel Langer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rik Gosselink, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Leuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29914940 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23921069 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S52852

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Inspiratory Muscle Training in Amateur Athletes
NCT06611969 ACTIVE_NOT_RECRUITING NA