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Inspiratory Muscle Training in Hypercapnic COPD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by Krankenhaus Kloster Grafschaft.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291460
First Posted: February 14, 2006
Last Update Posted: August 21, 2006
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.
Information provided by:
Krankenhaus Kloster Grafschaft
  Purpose
The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.

Condition Intervention Phase
COPD Respiratory Failure Device: inspiratory muscle training Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD

Resource links provided by NLM:


Further study details as provided by Krankenhaus Kloster Grafschaft:

Primary Outcome Measures:
  • inspiratory muscle strength
  • inspiratory muscle endurance
  • walking distance with dyspnea score
  • Carbon dioxide level

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: March 2008
Detailed Description:

Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance.

During this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD with FEV1/FVC < 70 %
  • age > 18
  • stable disease
  • able to walk
  • carbon dioxide >= 48 mmHg

Exclusion Criteria:

  • ejection fraction of the heart < 40 %
  • active psychiatric disease
  • bronchial hyperresponsiveness according to ATS criteria
  • pregnancy
  • renal insufficiency with a creatinine < 2 mg/dl
  Contacts and Locations
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): NCT00291460


Contacts
Contact: Dominic Dellweg, M.D. +49 2972 791 ext 1257 d.dellweg@fkkg.de

Locations
Germany
Fachkrankenhaus Kloster Grafschaft Recruiting
Schmallenberg, Germany, 57392
Contact: Dominic Dellweg, M.D.    +49 2972 ext 1257    d.dellweg@fkkg.de   
Principal Investigator: Dominic Dellweg, M.D.         
Sub-Investigator: Karina Reissig         
Sponsors and Collaborators
Krankenhaus Kloster Grafschaft
Investigators
Principal Investigator: Dominic Dellweg, M.D. FKKG
Study Chair: Dieter Koehler, Prof. Dr. FKKG
  More Information

ClinicalTrials.gov Identifier: NCT00291460     History of Changes
Other Study ID Numbers: FKKG IMT 0106
First Submitted: February 13, 2006
First Posted: February 14, 2006
Last Update Posted: August 21, 2006
Last Verified: February 2006

Keywords provided by Krankenhaus Kloster Grafschaft:
COPD
respiratory failure
inspiratory muscle training

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Aspiration
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms