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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: 6MWT with oxygen; Other: 6MWT with medical air

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schönau am Königssee, Germany, 83471
    • Klinikum Berchtesgadener Land, Schön Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"
Diffusion Capacity	change in diffusion capacity from baseline to 3 weeks	day 1 and 21
Lung Function	change in lung function from baseline to 3 weeks	day 1 and 21
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
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
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
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
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
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
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
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"
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
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
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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: April 21, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): November 6, 2011
• Last Update Submitted That Met QC Criteria: November 2, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: COPD III/IV; Oxygen Supply; Six-Minute-Walking-Test; Oxygen Responder
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BGL O2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No