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Trial Outcomes & Findings for Effect of Oxygen-supply on 6-Minute-Walking-Distance of COPD III/IV-patients (NCT NCT00886639)

NCT ID: NCT00886639

Last Updated: 2011-11-07

Results Overview

Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

127 participants

Primary outcome timeframe

day 1 and day 2; day 21 and day 22

Results posted on

2011-11-07

Participant Flow

inpatient rehabilitation programme, recruitment directly after admission.

Participant milestones

Participant milestones
Measure
6MWT With Different Gas Mixtures
Overall Study
STARTED
127
Overall Study
COMPLETED
111
Overall Study
NOT COMPLETED
16

Reasons for withdrawal

Reasons for withdrawal
Measure
6MWT With Different Gas Mixtures
Overall Study
acute exacerbation
14
Overall Study
non-compliance
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
6MWT With Different Gas Mixtures
n=127 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
60 Participants
n=5 Participants
Age, Categorical
>=65 years
67 Participants
n=5 Participants
Age Continuous
63.7 years
STANDARD_DEVIATION 8.74 • n=5 Participants
Sex: Female, Male
Female
54 Participants
n=5 Participants
Sex: Female, Male
Male
73 Participants
n=5 Participants
Region of Enrollment
Germany
127 participants
n=5 Participants
Forced expiratory volume in 1 second (FEV1%pred.)
35.5 percentage of predicted value
STANDARD_DEVIATION 11.5 • n=5 Participants

PRIMARY outcome

Timeframe: day 1 and day 2; day 21 and day 22

Population: per protocol

Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks

Outcome measures

Outcome measures
Measure
Oxygen Response
n=111 Participants
difference between 6-minute-walking test on oxygen and on medical air
Oxygen Response
26.9 Meter
Standard Deviation 41.9

SECONDARY outcome

Timeframe: day 1: minute "0" and "6"

change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1 and 21

change in diffusion capacity from baseline to 3 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1 and 21

change in lung function from baseline to 3 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1: minute 0 and minute 6

change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1: minute 0 and 6

Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 21: minute 0 and minute 6

change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 2: minute 0 and minute 6

change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 22: minute 0 and minute 6

change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 21: minute 0 and minute 6

change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 20: minute 0 and minute 6

change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 2: minute "0" and "6"

change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 2: minute 0 and 6

Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 21: minute 0 and 6

Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 22: minute 0 and 6

Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air

Outcome measures

Outcome data not reported

Adverse Events

6MWT With Different Gas Mixtures

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Klaus Kenn

Schön Klinik BGL

Phone: 0865293

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place