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Clinical Trials/NCT00291460
NCT00291460
Unknown
Phase 4

Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD

Krankenhaus Kloster Grafschaft1 site in 1 country40 target enrollmentFebruary 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
COPD
Sponsor
Krankenhaus Kloster Grafschaft
Enrollment
40
Locations
1
Primary Endpoint
inspiratory muscle strength
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
March 2008
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Krankenhaus Kloster Grafschaft

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

Outcomes

Primary Outcomes

inspiratory muscle strength

inspiratory muscle endurance

walking distance with dyspnea score

Carbon dioxide level

Study Sites (1)

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