Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903772
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

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.

Condition or disease Intervention/treatment Phase
COPD Inspiratory Muscle Weakness Other: Inspiratory Muscle Training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

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



Primary Outcome Measures :
  1. 6-Minute walking distance [ Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program ]

Secondary Outcome Measures :
  1. exercise capacity (constant work rate test) [ Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program ]
  2. maximal inspiratory pressure (PImax) [ Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program ]
  3. inspiratory muscle endurance capacity [ Time Frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program ]
  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903772


Locations
Layout table for location information
Germany
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Bayern, Germany, 83483
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
KU Leuven

Layout table for additonal information
Responsible Party: Klaus Kenn, MD, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01903772     History of Changes
Other Study ID Numbers: IMTCO
Schön Klinik BGL ( Other Identifier: Schön Klinik BGL )
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Muscle Weakness
Paresis
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms