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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Oxygen Response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
First of 2 6-minute-walking test with oxygen
Continuous flow of 2 liters per minute First with oxygen, second with medical air
Intervention: 6MWT with oxygen (Other)
First of 2 6-minute-walking test with oxygen
Continuous flow of 2 liters per minute First with oxygen, second with medical air
Intervention: 6MWT with medical air (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
Intervention: 6MWT with oxygen (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
Intervention: 6MWT with medical air (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Oxygen Partial Pressure (paO2)(day 2: minute "0" and "6")
- Diffusion Capacity(day 1 and 21)
- Lung Function(day 1 and 21)
- BORG-Score(day 21: minute 0 and minute 6)
- Oxygen Saturation(day 22: minute 0 and 6)
- Oxygen Partial Pressure (paO2)(day 1: minute "0" and "6")
- BORG-Score(day 1: minute 0 and minute 6)
- Oxygen Saturation(day 1: minute 0 and 6)
- Oxygen Partial Pressure (paO2)(day 21: minute 0 and minute 6)
- BORG-Score(day 2: minute 0 and minute 6)
- BORG-Score(day 22: minute 0 and minute 6)
- Oxygen Partial Pressure (paO2)(day 20: minute 0 and minute 6)
- Oxygen Saturation(day 2: minute 0 and 6)
- Oxygen Saturation(day 21: minute 0 and 6)
Investigators
Klaus Kenn
Head physician (department of pneumology)
Schön Klinik Berchtesgadener Land