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

Study Overview
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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.

Official Title
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Effect Of Oxygen-Supply On The 6-Minute-Walking-Distance in Patients With Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage III/IV Before And After A Multimodal Rehabilitation

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: 6MWT with oxygen
* Other: 6MWT with medical air


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First of 2 6-minute-walking test with oxygen<br>Continuous flow of 2 liters per minute First with oxygen, second with medical air | Other: 6MWT with oxygen<br>* 2 liter per minute as continuous-flow<br>Other: 6MWT with medical air<br>* 2 liters as continuous-flow<br>|
| Other: First of 2 6-minute-walking tests with medical air<br>Medical air is compressed room air. First test with medical air, second with oxygen | Other: 6MWT with oxygen<br>* 2 liter per minute as continuous-flow<br>Other: 6MWT with medical air<br>* 2 liters as continuous-flow<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 1: minute 0 and 6 | 
| Diffusion Capacity | change in diffusion capacity from baseline to 3 weeks | day 1 and 21 | 
| Lung Function | change in lung function from baseline to 3 weeks | day 1 and 21 | 
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 1: minute 0 and minute 6 | 
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 1: minute 0 and 6 | 
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 21: minute 0 and minute 6 | 
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 2: minute 0 and minute 6 | 
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 22: minute 0 and minute 6 | 
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 21: minute 0 and minute 6 | 
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 20: minute 0 and minute 6 | 
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 2: minute 0 and 6 | 
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 2: minute 0 and 6 | 
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 21: minute 0 and 6 | 
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 22: minute 0 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD III/IV, Oxygen Supply, Six-Minute-Walking-Test, Oxygen Responder