Clinical trial NCT00886639: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD III/IV
Oxygen Supply
Six-Minute-Walking-Test
Oxygen Responder
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: ROX Medical, Inc.
First posted: 2009-04-23
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Oxygen Response
timeFrame: day 1 and day 2; day 21 and day 22
Secondary outcomes:
measure: Oxygen Partial Pressure (paO2)
timeFrame: day 1: minute "0" and "6"
measure: Diffusion Capacity
timeFrame: day 1 and 21
measure: Lung Function
timeFrame: day 1 and 21
measure: BORG-Score
timeFrame: day 1: minute 0 and minute 6
measure: Oxygen Saturation
timeFrame: day 1: minute 0 and 6
measure: Oxygen Partial Pressure (paO2)
timeFrame: day 21: minute 0 and minute 6
measure: BORG-Score
timeFrame: day 2: minute 0 and minute 6
measure: BORG-Score
timeFrame: day 22: minute 0 and minute 6
measure: BORG-Score
timeFrame: day 21: minute 0 and minute 6
measure: Oxygen Partial Pressure (paO2)
timeFrame: day 20: minute 0 and minute 6
measure: Oxygen Partial Pressure (paO2)
timeFrame: day 2: minute "0" and "6"
measure: Oxygen Saturation
timeFrame: day 2: minute 0 and 6
measure: Oxygen Saturation
timeFrame: day 21: minute 0 and 6
measure: Oxygen Saturation
timeFrame: day 22: minute 0 and 6
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Klinikum Berchtesgadener Land, Schön Kliniken
Study officials:
affiliation: Klinikum Berchtesgadener Land, Schön Kliniken
name: Klaus Kenn, Dr.med.
role: STUDY_DIRECTOR
affiliation: Klinikum Berchtesgadener Land, Schön Kliniken
name: Inga Heinzelmann, Dipl. Sportw
role: PRINCIPAL_INVESTIGATOR
References:
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.