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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
Sponsor:
Collaborator:
ROX Medical, Inc.
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: 6MWT with oxygen Other: 6MWT with medical air Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Diffusion Capacity [ Time Frame: day 1 and 21 ]
    change in diffusion capacity from baseline to 3 weeks

  3. Lung Function [ Time Frame: day 1 and 21 ]
    change in lung function from baseline to 3 weeks

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

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


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
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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