search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
6MWT with oxygen
6MWT with medical air
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD III/IV, Oxygen Supply, Six-Minute-Walking-Test, Oxygen Responder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Berchtesgadener Land, Schön Kliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

First of 2 6-minute-walking test with oxygen

First of 2 6-minute-walking tests with medical air

Arm Description

Continuous flow of 2 liters per minute First with oxygen, second with medical air

Medical air is compressed room air. First test with medical air, second with oxygen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Diffusion Capacity
change in diffusion capacity from baseline to 3 weeks
Lung Function
change in lung function from baseline to 3 weeks
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air

Full Information

First Posted
April 21, 2009
Last Updated
November 2, 2011
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ROX Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00886639
Brief Title
Effect of Oxygen-supply on 6-Minute-Walking-Distance of COPD III/IV-patients
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ROX Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD III/IV, Oxygen Supply, Six-Minute-Walking-Test, Oxygen Responder

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First of 2 6-minute-walking test with oxygen
Arm Type
Other
Arm Description
Continuous flow of 2 liters per minute First with oxygen, second with medical air
Arm Title
First of 2 6-minute-walking tests with medical air
Arm Type
Other
Arm Description
Medical air is compressed room air. First test with medical air, second with oxygen
Intervention Type
Other
Intervention Name(s)
6MWT with oxygen
Intervention Description
2 liter per minute as continuous-flow
Intervention Type
Other
Intervention Name(s)
6MWT with medical air
Intervention Description
2 liters as continuous-flow
Primary Outcome Measure Information:
Title
Oxygen Response
Description
Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks
Time Frame
day 1 and day 2; day 21 and day 22
Secondary Outcome Measure Information:
Title
Oxygen Partial Pressure (paO2)
Description
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time Frame
day 1: minute "0" and "6"
Title
Diffusion Capacity
Description
change in diffusion capacity from baseline to 3 weeks
Time Frame
day 1 and 21
Title
Lung Function
Description
change in lung function from baseline to 3 weeks
Time Frame
day 1 and 21
Title
BORG-Score
Description
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time Frame
day 1: minute 0 and minute 6
Title
Oxygen Saturation
Description
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time Frame
day 1: minute 0 and 6
Title
Oxygen Partial Pressure (paO2)
Description
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time Frame
day 21: minute 0 and minute 6
Title
BORG-Score
Description
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time Frame
day 2: minute 0 and minute 6
Title
BORG-Score
Description
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time Frame
day 22: minute 0 and minute 6
Title
BORG-Score
Description
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time Frame
day 21: minute 0 and minute 6
Title
Oxygen Partial Pressure (paO2)
Description
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time Frame
day 20: minute 0 and minute 6
Title
Oxygen Partial Pressure (paO2)
Description
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time Frame
day 2: minute "0" and "6"
Title
Oxygen Saturation
Description
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time Frame
day 2: minute 0 and 6
Title
Oxygen Saturation
Description
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time Frame
day 21: minute 0 and 6
Title
Oxygen Saturation
Description
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time Frame
day 22: minute 0 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr.med.
Organizational Affiliation
Klinikum Berchtesgadener Land, Schön Kliniken
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Inga Heinzelmann, Dipl. Sportw
Organizational Affiliation
Klinikum Berchtesgadener Land, Schön Kliniken
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Berchtesgadener Land, Schön Kliniken
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27940278
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs