Inspiratory Muscle Training in Hypercapnic COPD

Phase 4

• Conditions: COPD; Respiratory Failure

• Registration Number: NCT00291460
• Lead Sponsor: Krankenhaus Kloster Grafschaft

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.

Study Timeline

• Status Verified: 2006-02
• Study Start: 2006-02
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-14
• Last Update Submitted: 2006-08-18
• Last Update Posted: 2006-08-21
• Study Completion: 2008-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
inspiratory muscle strength
inspiratory muscle endurance
walking distance with dyspnea score
Carbon dioxide level

Trial Locations

Locations (1)

Fachkrankenhaus Kloster Grafschaft; 🇩🇪 Schmallenberg, Germany