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

March 1, 2017 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Schönau am Königssee, Bayern, Germany, 83483
        • Schön Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory Muscle Training
Procedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max
Other: Inspiratory Muscle Training
Sham Comparator: Sham Inspiratory Muscle Training
Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O)
Other: Inspiratory Muscle Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6-Minute walking distance
Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exercise capacity (constant work rate test)
Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
maximal inspiratory pressure (PImax)
Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
inspiratory muscle endurance capacity
Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
dyspnea
Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
measured via Borg-scale at rest, during 6-minute walking distance, during constant work rate test at iso-time, during inspiratory muscle endurance capacity test
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMTCO
  • Schön Klinik BGL (Other Identifier: Schön Klinik BGL)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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