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Completed

NCT Number: NCT00886639

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6MWT with oxygen

Other

2 liter per minute as continuous-flow

6MWT with medical air

Other

2 liters as continuous-flow

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • ROX Medical, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 23, 2009
Registry last updated
Nov 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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