IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 24, 2017