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

Schön Klinik Berchtesgadener Land127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

127

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

6MWT with oxygenOTHER

2 liter per minute as continuous-flow

6MWT with medical airOTHER

2 liters as continuous-flow

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Germany

Outcomes

Primary Outcomes

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

Time frame: day 1 and day 2; day 21 and day 22

Secondary Outcomes

Oxygen Partial Pressure (paO2)

change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air

Time frame: day 1: minute "0" and "6"

Diffusion Capacity

change in diffusion capacity from baseline to 3 weeks

Time frame: day 1 and 21

Lung Function

change in lung function from baseline to 3 weeks

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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