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Effect of Oxygen-supply on 6-Minute-Walking-Distance of COPD III/IV-patients
This study has been completed.
Sponsor:
Klinikum Berchtesgadener Land der Schön-Kliniken
Collaborator:
ROX Medical, Inc.
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT00886639
First received: April 21, 2009
Last updated: November 2, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
| Chronic Obstructive Pulmonary Disease | Other: 6MWT with oxygen Other: 6MWT with medical air |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 127 |
| Study Start Date: | December 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00886639
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886639
Locations
| Germany | |
| Klinikum Berchtesgadener Land, Schön Kliniken | |
| Schönau am Königssee, Germany, 83471 | |
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
ROX Medical, Inc.
Investigators
| Study Director: | Klaus Kenn, Dr.med. | Klinikum Berchtesgadener Land, Schön Kliniken |
| Principal Investigator: | Inga Heinzelmann, Dipl. Sportw | Klinikum Berchtesgadener Land, Schön Kliniken |
More Information
| 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 |
| Study First Received: | April 21, 2009 |
| Results First Received: | June 22, 2011 |
| Last Updated: | November 2, 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 |
ClinicalTrials.gov processed this record on June 23, 2017