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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886639
• Other study ID #: BGL O2
• Status: Completed
• Phase: N/A
• First received: April 21, 2009
• Last updated: November 2, 2011
• Start date: December 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2011
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 6MWT with oxygen
2 liter per minute as continuous-flow
• 6MWT with medical air
2 liters as continuous-flow

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land, Schön Kliniken	Schönau am Königssee

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken	ROX Medical, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Response	Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks	day 1 and day 2; day 21 and day 22	Yes
Secondary	Oxygen Partial Pressure (paO2)	change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air	day 1: minute "0" and "6"	No
Secondary	Diffusion Capacity	change in diffusion capacity from baseline to 3 weeks	day 1 and 21	No
Secondary	Lung Function	change in lung function from baseline to 3 weeks	day 1 and 21	No
Secondary	BORG-Score	change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air	day 1: minute 0 and minute 6	No
Secondary	Oxygen Saturation	Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air	day 1: minute 0 and 6	No
Secondary	Oxygen Partial Pressure (paO2)	change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air	day 21: minute 0 and minute 6	No
Secondary	BORG-Score	change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air	day 2: minute 0 and minute 6	No
Secondary	BORG-Score	change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air	day 22: minute 0 and minute 6	No
Secondary	BORG-Score	change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air	day 21: minute 0 and minute 6	No
Secondary	Oxygen Partial Pressure (paO2)	change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air	day 20: minute 0 and minute 6	No
Secondary	Oxygen Partial Pressure (paO2)	change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air	day 2: minute "0" and "6"	No
Secondary	Oxygen Saturation	Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air	day 2: minute 0 and 6	No
Secondary	Oxygen Saturation	Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air	day 21: minute 0 and 6	No
Secondary	Oxygen Saturation	Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air	day 22: minute 0 and 6	No