Effect of Oxygen-supply on 6-Minute-Walking-Distance of COPD III/IV-patients
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ClinicalTrials.gov Identifier: NCT00886639 |
Recruitment Status
:
Completed
First Posted
: April 23, 2009
Results First Posted
: July 22, 2011
Last Update Posted
: November 7, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Other: 6MWT with oxygen Other: 6MWT with medical air | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 127 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Screening |
Official Title: | 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 |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
First of 2 6-minute-walking test with oxygen
Continuous flow of 2 liters per minute First with oxygen, second with medical air
|
Other: 6MWT with oxygen
2 liter per minute as continuous-flow
Other: 6MWT with medical air
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
|
Other: 6MWT with oxygen
2 liter per minute as continuous-flow
Other: 6MWT with medical air
2 liters as continuous-flow
|
- Oxygen Response [ Time Frame: 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
- Oxygen Partial Pressure (paO2) [ Time Frame: day 1: minute "0" and "6" ]change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
- Diffusion Capacity [ Time Frame: day 1 and 21 ]change in diffusion capacity from baseline to 3 weeks
- Lung Function [ Time Frame: day 1 and 21 ]change in lung function from baseline to 3 weeks
- BORG-Score [ Time Frame: day 1: 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 [ Time Frame: day 1: minute 0 and 6 ]Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
- Oxygen Partial Pressure (paO2) [ Time Frame: day 21: minute 0 and minute 6 ]change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
- BORG-Score [ Time Frame: day 2: 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
- BORG-Score [ Time Frame: day 22: 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
- BORG-Score [ Time Frame: 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 Partial Pressure (paO2) [ Time Frame: day 20: minute 0 and minute 6 ]change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
- Oxygen Partial Pressure (paO2) [ Time Frame: day 2: minute "0" and "6" ]change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
- Oxygen Saturation [ Time Frame: day 2: minute 0 and 6 ]Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
- Oxygen Saturation [ Time Frame: day 21: minute 0 and 6 ]Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
- Oxygen Saturation [ Time Frame: day 22: minute 0 and 6 ]Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886639
Germany | |
Klinikum Berchtesgadener Land, Schön Kliniken | |
Schönau am Königssee, Germany, 83471 |
Study Director: | Klaus Kenn, Dr.med. | Klinikum Berchtesgadener Land, Schön Kliniken | |
Principal Investigator: | Inga Heinzelmann, Dipl. Sportw | Klinikum Berchtesgadener Land, Schön Kliniken |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Klaus Kenn, Head physician (department of pneumology), Klinikum Berchtesgadener Land der Schön-Kliniken |
ClinicalTrials.gov Identifier: | NCT00886639 History of Changes |
Other Study ID Numbers: |
BGL O2 |
First Posted: | April 23, 2009 Key Record Dates |
Results First Posted: | July 22, 2011 |
Last Update Posted: | November 7, 2011 |
Last Verified: | November 2011 |
Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
COPD III/IV Oxygen Supply Six-Minute-Walking-Test Oxygen Responder |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |