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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, 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

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jarosch I, Gloeckl R, Damm E, Schwedhelm AL, Buhrow D, Jerrentrup A, Spruit MA, Kenn K. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial. Chest. 2017 Apr;151(4):795-803. doi: 10.1016/j.chest.2016.11.044. Epub 2016 Dec 8.

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
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