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Inspiratory Muscle Training in Hypercapnic COPD

NCT ID: NCT00291460

Last Updated: 2006-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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COPD Respiratory Failure

Keywords

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COPD respiratory failure inspiratory muscle training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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inspiratory muscle training

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Kloster Grafschaft

OTHER

Sponsor Role lead

Principal Investigators

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Dominic Dellweg, M.D.

Role: PRINCIPAL_INVESTIGATOR

FKKG

Dieter Koehler, Prof. Dr.

Role: STUDY_CHAIR

FKKG

Locations

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Fachkrankenhaus Kloster Grafschaft

Schmallenberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dominic Dellweg, M.D.

Role: CONTACT

Phone: +49 2972 791

Email: [email protected]

Facility Contacts

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Dominic Dellweg, M.D.

Role: primary

Other Identifiers

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FKKG IMT 0106

Identifier Type: -

Identifier Source: org_study_id