Trial Outcomes & Findings for Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation (NCT NCT00740220)
NCT ID: NCT00740220
Last Updated: 2017-12-15
Results Overview
The kappa statistic is a measure of the quality of a test. It is a ratio.
Recruitment status
COMPLETED
Target enrollment
97 participants
Primary outcome timeframe
All three 6MWTs should take place within 30 days
Results posted on
2017-12-15
Participant Flow
Participant milestones
| Measure |
Single Arm Prospective Observational Study
Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Single Arm Prospective Observational Study
Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
|
|---|---|
|
Overall Study
screen failures (non-COPD patients)
|
9
|
Baseline Characteristics
Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation
Baseline characteristics by cohort
| Measure |
Single Arm Prospective Observational Study
n=97 Participants
Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All three 6MWTs should take place within 30 daysThe kappa statistic is a measure of the quality of a test. It is a ratio.
Outcome measures
| Measure |
Single Arm Prospective Observational Study
n=88 Participants
Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
|
|---|---|
|
Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)
|
0.62 Ratio
|
Adverse Events
Single Arm Prospective Observational Study
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place