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
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014