Inspiratory Muscle Training in Hypercapnic COPD

• Sponsor: Krankenhaus Kloster Grafschaft (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00291460
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 24.9
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Respiratory Failure	Device: inspiratory muscle training	Phase 4

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD
• Study Start Date: Feb 1, 2006
• Study Completion Date: Mar 1, 2008

Outcome Measures

Primary Outcome Measures

1. inspiratory muscle strength []

2. inspiratory muscle endurance []

3. walking distance with dyspnea score []

4. Carbon dioxide level []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Fachkrankenhaus Kloster Grafschaft	Schmallenberg		Germany	57392

Sponsors and Collaborators

• Krankenhaus Kloster Grafschaft

Investigators

• Principal Investigator: Dominic Dellweg, M.D., FKKG
• Study Chair: Dieter Koehler, Prof. Dr., FKKG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00291460
• Other Study ID Numbers: FKKG IMT 0106
• First Posted: Feb 14, 2006
• Last Update Posted: Aug 21, 2006
• Last Verified: Feb 1, 2006

• Keywords provided by , ,: COPD; respiratory failure; inspiratory muscle training
• Additional relevant MeSH terms: Respiratory Insufficiency; Respiratory Aspiration

Study Results

No Results Posted as of Aug 21, 2006