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

This study has been completed.
Sponsor:
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
  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 (Subject)
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 Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • Oxygen Response [ Time Frame: day 1 and day 2; day 21 and day 22 ] [ Designated as safety issue: Yes ]
    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" ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    change in diffusion capacity from baseline to 3 weeks

  • Lung Function [ Time Frame: day 1 and 21 ] [ Designated as safety issue: No ]
    change in lung function from baseline to 3 weeks

  • BORG-Score [ Time Frame: day 1: minute 0 and minute 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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" ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

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

No publications provided

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
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Berchtesgadener Land der Schön-Kliniken:
COPD III/IV
Oxygen Supply
Six-Minute-Walking-Test
Oxygen Responder

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 02, 2014