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Inspiratory Muscle Training in Hypercapnic COPD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Krankenhaus Kloster Grafschaft.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier:
NCT00291460
First received: February 13, 2006
Last updated: August 18, 2006
Last verified: February 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00291460     History of Changes
Other Study ID Numbers: FKKG IMT 0106
Study First Received: February 13, 2006
Last Updated: August 18, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Respiratory Aspiration
Hypercapnia
Pulmonary Disease, Chronic Obstructive
Hypoventilation
Respiratory Insufficiency
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases, Obstructive
Lung Diseases

ClinicalTrials.gov processed this record on May 19, 2013