Chronic Obstructive Pulmonary DiseaseNCT00886639
Effect of Oxygen-supply on 6-Minute-Walking-Distance of COPD III/IV-patients
A study testing 6MWT with oxygen and 6MWT with medical air in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- 6MWT with oxygen and 6MWT with medical air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic obstructive pulmonary disease III/IV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, 83471
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- 6MWT with oxygen, 6MWT with medical air
- Keywords
- COPD III/IV, Oxygen Supply, Six-Minute-Walking-Test, Oxygen Responder
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MWT with oxygenOther
2 liter per minute as continuous-flow
6MWT with medical airOther
2 liters as continuous-flow
| Study group | Role | What they receive |
|---|---|---|
| First of 2 6-minute-walking test with oxygen | Other | Continuous flow of 2 liters per minute First with oxygen, second with medical air Receives: Other: 6MWT with oxygen; Other: 6MWT with medical air |
| First of 2 6-minute-walking tests with medical air | Other | Medical air is compressed room air. First test with medical air, second with oxygen Receives: Other: 6MWT with oxygen; Other: 6MWT with medical air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1 and day 2; day 21 and day 22
Secondary outcomes (14)
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Measured: day 1: minute "0" and "6"
Diffusion Capacity
change in diffusion capacity from baseline to 3 weeks
Measured: day 1 and 21
Lung Function
change in lung function from baseline to 3 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: day 22: minute 0 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- ROX Medical, Inc.
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Dr.med., Study director, Klinikum Berchtesgadener Land, Schön KlinikenInga Heinzelmann, Dipl. Sportw, Principal investigator, Klinikum Berchtesgadener Land, Schön Kliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886639
- Sponsor's protocol ID
- BGL O2
- Status last verified
- Nov 2011
- First submitted
- 21 Apr 2009
- Last updated
- 7 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 27940278
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00886639
- Acronym / sponsor ID
- BGL O2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD III/IV, Oxygen Supply, Six-Minute-Walking-Test, Oxygen Responder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- ROX Medical, Inc.
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 22 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First of 2 6-minute-walking test with oxygen | Other | Other: 6MWT with oxygen, Other: 6MWT with medical airContinuous flow of 2 liters per minute First with oxygen, second with medical air |
| First of 2 6-minute-walking tests with medical air | Other | Other: 6MWT with oxygen, Other: 6MWT with medical airMedical air is compressed room air. First test with medical air, second with oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic obstructive pulmonary disease III/IV
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6MWT with oxygen2 liter per minute as continuous-flow | Other | First of 2 6-minute-walking test with oxygen, First of 2 6-minute-walking tests with medical air |
| 6MWT with medical air2 liters as continuous-flow | Other | First of 2 6-minute-walking test with oxygen, First of 2 6-minute-walking tests with medical air |
Primary outcome
Oxygen Response
Time frame: day 1 and day 2; day 21 and day 22
Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks
14 secondary outcomes
Oxygen Partial Pressure (paO2)
Time frame: day 1: minute "0" and "6"
Diffusion Capacity
Time frame: day 1 and 21
Lung Function
Time frame: day 1 and 21
BORG-Score
Time frame: day 1: minute 0 and minute 6
Oxygen Saturation
Time frame: day 1: minute 0 and 6
Oxygen Partial Pressure (paO2)
Time frame: day 21: minute 0 and minute 6
BORG-Score
Time frame: day 2: minute 0 and minute 6
BORG-Score
Time frame: day 22: minute 0 and minute 6
BORG-Score
Time frame: day 21: minute 0 and minute 6
Oxygen Partial Pressure (paO2)
Time frame: day 20: minute 0 and minute 6
Oxygen Partial Pressure (paO2)
Time frame: day 2: minute "0" and "6"
Oxygen Saturation
Time frame: day 2: minute 0 and 6
Oxygen Saturation
Time frame: day 21: minute 0 and 6
Oxygen Saturation
Time frame: day 22: minute 0 and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27940278Jarosch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, Dr.med. study director
Klinikum Berchtesgadener Land, Schön Kliniken
Inga Heinzelmann, Dipl. Sportw principal investigator
Klinikum Berchtesgadener Land, Schön Kliniken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6MWT with oxygen and 6MWT with medical air in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Response (time frame: day 1 and day 2; day 21 and day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011.