NCT00886639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 22, 2011

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

6 months

First QC Date

April 21, 2009

Results QC Date

June 22, 2011

Last Update Submit

November 2, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD III/IVOxygen SupplySix-Minute-Walking-TestOxygen Responder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Oxygen Partial Pressure (paO2)

    day 1: minute "0" and "6"

  • Diffusion Capacity

    day 1 and 21

  • Lung Function

    day 1 and 21

  • BORG-Score

    day 1: minute 0 and minute 6

  • Oxygen Saturation

    day 1: minute 0 and 6

  • +9 more secondary outcomes

Study Arms (2)

First of 2 6-minute-walking test with oxygen

OTHER

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

Other: 6MWT with oxygenOther: 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

Other: 6MWT with oxygenOther: 6MWT with medical air

Interventions

6MWT with oxygenOTHER

2 liter per minute as continuous-flow

First of 2 6-minute-walking test with oxygenFirst of 2 6-minute-walking tests with medical air
6MWT with medical airOTHER

2 liters as continuous-flow

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic obstructive pulmonary disease III/IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, 83471, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27940278DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

OxygenAir

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Results Point of Contact

Title
Dr. Klaus Kenn
Organization
Schön Klinik BGL
iheinzelmann@schoen-kliniken.de
0865293

Study Officials

  • Klaus Kenn, Dr.med.

    Klinikum Berchtesgadener Land, Schön Kliniken

    STUDY DIRECTOR

  • Inga Heinzelmann, Dipl. Sportw

    Klinikum Berchtesgadener Land, Schön Kliniken

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physician (department of pneumology)

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

December 1, 2008

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

November 7, 2011

Results First Posted

July 22, 2011

Record last verified: 2011-11

Locations

DE(1)