Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01903772

Last Updated: 2017-03-03

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-02-28

Brief Summary

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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

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Conditions

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COPD Inspiratory Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Inspiratory Muscle Training

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

Group Type EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type OTHER

Sham Inspiratory Muscle Training

Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O)

Group Type SHAM_COMPARATOR

Inspiratory Muscle Training

Intervention Type OTHER

Interventions

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Inspiratory Muscle Training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with COPD
* Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
* Pi,max \<60 centimeters of water or \<50% of the predicted normal value

Exclusion Criteria

* Major comorbidities preventing successful participation in an 8 week exercise training intervention
* use of non-invasive ventilation
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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Schön Klinik BGL

Identifier Type: OTHER

Identifier Source: secondary_id

IMTCO

Identifier Type: -

Identifier Source: org_study_id

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