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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: 6MWT with oxygen; Other: 6MWT with medical air

• Registration Number: NCT00886639
• Lead Sponsor: Schön Klinik Berchtesgadener Land

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Results First Submitted: 2011-06-22
• Results First Submitted QC: 2011-06-24
• Results First Posted: 2011-07-22
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-02
• Last Update Posted: 2011-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First of 2 6-minute-walking test with oxygen	6MWT with oxygen	Continuous flow of 2 liters per minute First with oxygen, second with medical air
First of 2 6-minute-walking tests with medical air	6MWT with oxygen	Medical air is compressed room air. First test with medical air, second with oxygen
First of 2 6-minute-walking tests with medical air	6MWT with medical air	Medical air is compressed room air. First test with medical air, second with oxygen
First of 2 6-minute-walking test with oxygen	6MWT with medical air	Continuous flow of 2 liters per minute First with oxygen, second with medical air

Primary Outcome Measures

Name	Time	Method
Oxygen Response	day 1 and day 2; day 21 and day 22	Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Oxygen Partial Pressure (paO2)	day 2: minute "0" and "6"	change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Diffusion Capacity	day 1 and 21	change in diffusion capacity from baseline to 3 weeks
Lung Function	day 1 and 21	change in lung function from baseline to 3 weeks
BORG-Score	day 21: minute 0 and minute 6	change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Oxygen Saturation	day 22: minute 0 and 6	Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air

Trial Locations

Locations (1)

Klinikum Berchtesgadener Land, Schön Kliniken; 🇩🇪 Schönau am Königssee, Germany