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

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:

MedlinePlus related topics: COPD Oxygen Therapy

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on February 25, 2015