Trial Outcomes & Findings for Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients (NCT NCT01118221)
NCT ID: NCT01118221
Last Updated: 2015-03-04
Results Overview
Change in 6 Minute Walk Distance from Baseline to 3 Months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
The 6-MWD will be measured at 0 and 3 months.
Results posted on
2015-03-04
Participant Flow
Participant milestones
| Measure |
Pulmonary Rehabilitation
enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program
|
Control
no structured exercise
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients
Baseline characteristics by cohort
| Measure |
Pulmonary Rehabilitation
n=14 Participants
enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program
|
Control
n=11 Participants
no structured exercise
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 6 • n=5 Participants
|
66 years
STANDARD_DEVIATION 7 • n=7 Participants
|
69 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
South America
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The 6-MWD will be measured at 0 and 3 months.Change in 6 Minute Walk Distance from Baseline to 3 Months
Outcome measures
| Measure |
Arm 1
n=14 Participants
enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program
|
Arm 2
n=11 Participants
no structured exercise
|
|---|---|---|
|
6 Minute Walk Distance
|
-6.2 meters
Standard Deviation 86.9
|
-15.3 meters
Standard Deviation 42.9
|
SECONDARY outcome
Timeframe: Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.
Outcome measures
| Measure |
Arm 1
n=25 Participants
enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program
|
Arm 2
n=25 Participants
no structured exercise
|
|---|---|---|
|
Systemic Markers of Oxidant Stress
|
16.48 pg/mL
Standard Deviation 10.10
|
17.96 pg/mL
Standard Deviation 10.05
|
SECONDARY outcome
Timeframe: Maximum O2 uptake will be measured at 0 and 3 months.Change in 6 peak O2 uptake from Baseline to 3 Months
Outcome measures
| Measure |
Arm 1
n=14 Participants
enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program
|
Arm 2
n=11 Participants
no structured exercise
|
|---|---|---|
|
Maximum Oxygen Uptake
|
-35 mL/minute
Standard Error 71
|
-119 mL/minute
Standard Error 62
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
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