- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00291460
Inspiratory Muscle Training in Hypercapnic COPD
Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dominic Dellweg, M.D.
- Phone Number: 1257 +49 2972 791
- Email: d.dellweg@fkkg.de
Study Locations
-
-
-
Schmallenberg, Germany, 57392
- Recruiting
- Fachkrankenhaus Kloster Grafschaft
-
Principal Investigator:
- Dominic Dellweg, M.D.
-
Contact:
- Dominic Dellweg, M.D.
- Phone Number: 1257 +49 2972
- Email: d.dellweg@fkkg.de
-
Sub-Investigator:
- Karina Reissig
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
inspiratory muscle strength
|
inspiratory muscle endurance
|
walking distance with dyspnea score
|
Carbon dioxide level
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominic Dellweg, M.D., FKKG
- Study Chair: Dieter Koehler, Prof. Dr., FKKG
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FKKG IMT 0106
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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