Inspiratory Muscle Training in Hypercapnic COPD
Primary Purpose
COPD, Respiratory Failure
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
inspiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, respiratory failure, inspiratory muscle training
Eligibility 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
Sites / Locations
- Fachkrankenhaus Kloster GrafschaftRecruiting
Outcomes
Primary Outcome Measures
inspiratory muscle strength
inspiratory muscle endurance
walking distance with dyspnea score
Carbon dioxide level
Secondary Outcome Measures
Full Information
NCT ID
NCT00291460
First Posted
February 13, 2006
Last Updated
August 18, 2006
Sponsor
Krankenhaus Kloster Grafschaft
1. Study Identification
Unique Protocol Identification Number
NCT00291460
Brief Title
Inspiratory Muscle Training in Hypercapnic COPD
Official Title
Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Krankenhaus Kloster Grafschaft
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Respiratory Failure
Keywords
COPD, respiratory failure, inspiratory muscle training
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
inspiratory muscle training
Primary Outcome Measure Information:
Title
inspiratory muscle strength
Title
inspiratory muscle endurance
Title
walking distance with dyspnea score
Title
Carbon dioxide level
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominic Dellweg, M.D.
Phone
+49 2972 791
Ext
1257
Email
d.dellweg@fkkg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Dellweg, M.D.
Organizational Affiliation
FKKG
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dieter Koehler, Prof. Dr.
Organizational Affiliation
FKKG
Official's Role
Study Chair
Facility Information:
Facility Name
Fachkrankenhaus Kloster Grafschaft
City
Schmallenberg
ZIP/Postal Code
57392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Dellweg, M.D.
Phone
+49 2972
Ext
1257
Email
d.dellweg@fkkg.de
First Name & Middle Initial & Last Name & Degree
Dominic Dellweg, M.D.
First Name & Middle Initial & Last Name & Degree
Karina Reissig
12. IPD Sharing Statement
Learn more about this trial
Inspiratory Muscle Training in Hypercapnic COPD
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