Inspiratory Muscle Training in Hypercapnic COPD - Full Text View

Sponsored by:	Krankenhaus Kloster Grafschaft
Information provided by:	Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier:	NCT00291460

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD

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

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

Keywords provided by Krankenhaus Kloster Grafschaft:

COPD
respiratory failure
inspiratory muscle training

Study placed in the following topic categories:

Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases
Hypercapnia

Lung Diseases
Respiration Disorders
Hypoventilation
Signs and Symptoms, Respiratory
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009