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Effect of Oxygen-supply on 6-Minute-Walking-Distance of COPD III/IV-patients

NCT ID: NCT00886639

Last Updated: 2011-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-08-31

Brief Summary

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The aim of this study is to investigate the six-minute-walking-distance of COPD-patients with breathing oxygen in comparison to breathing normal air. Patients, who increase their walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called "Oxygen Responders." The study is aimed to find attributes of Oxygen Responder and to investigate, if a patient can change the "respond" with higher performance and endurance.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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First of 2 6-minute-walking test with oxygen

Continuous flow of 2 liters per minute First with oxygen, second with medical air

Group Type OTHER

6MWT with oxygen

Intervention Type OTHER

2 liter per minute as continuous-flow

6MWT with medical air

Intervention Type OTHER

2 liters as continuous-flow

First of 2 6-minute-walking tests with medical air

Medical air is compressed room air. First test with medical air, second with oxygen

Group Type OTHER

6MWT with oxygen

Intervention Type OTHER

2 liter per minute as continuous-flow

6MWT with medical air

Intervention Type OTHER

2 liters as continuous-flow

Interventions

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6MWT with oxygen

2 liter per minute as continuous-flow

Intervention Type OTHER

6MWT with medical air

2 liters as continuous-flow

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic obstructive pulmonary disease III/IV

Exclusion Criteria

* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
* Severe exacerbation during rehabilitation
* Cardiac insufficiency
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ROX Medical, Inc.

INDUSTRY

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Head physician (department of pneumology)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Kenn, Dr.med.

Role: STUDY_DIRECTOR

Klinikum Berchtesgadener Land, Schön Kliniken

Inga Heinzelmann, Dipl. Sportw

Role: PRINCIPAL_INVESTIGATOR

Klinikum Berchtesgadener Land, Schön Kliniken

Locations

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Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, , Germany

Site Status

Countries

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Germany

References

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Jarosch I, Gloeckl R, Damm E, Schwedhelm AL, Buhrow D, Jerrentrup A, Spruit MA, Kenn K. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial. Chest. 2017 Apr;151(4):795-803. doi: 10.1016/j.chest.2016.11.044. Epub 2016 Dec 8.

Reference Type DERIVED
PMID: 27940278 (View on PubMed)

Other Identifiers

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BGL O2

Identifier Type: -

Identifier Source: org_study_id