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NCT01397396 Clinical Trial

Effects of Inspiratory Muscle Training in COPD

COPD Clinical Trial

— IMTCO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01397396
Other study ID # S52852
Secondary ID
Status Completed
Phase Phase 3
First received July 18, 2011
Last updated March 12, 2017
Start date February 2012
Est. completion date December 2016

Study information
Verified date March 2017
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 208
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Inspiratory Muscle Training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max

Locations
Country Name City State
Belgium University Hospital Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 6-Minute Walking Distance Baseline and 8 weeks follow-up
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