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 (Chronic Obstructive Pulmonary Disease) 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

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 June 18, 2013