Inspiratory Muscle Training in Hypercapnic COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00291460
• Other study ID #: FKKG IMT 0106
• Status: Recruiting
• Phase: Phase 4
• First received: February 13, 2006
• Last updated: August 18, 2006
• Start date: February 2006
• Est. completion date: March 2008

Study information

• Verified date: February 2006
• Source: Krankenhaus Kloster Grafschaft
• Contact: Dominic Dellweg, M.D.
• Phone: +49 2972 791
• Email: d.dellweg[@]fkkg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Respiratory Aspiration
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• inspiratory muscle training

Locations

Country	Name	City	State
Germany	Fachkrankenhaus Kloster Grafschaft	Schmallenberg

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Kloster Grafschaft

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inspiratory muscle strength
Primary	inspiratory muscle endurance
Primary	walking distance with dyspnea score
Primary	Carbon dioxide level