Trial Outcomes & Findings for The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease (NCT NCT02019641)
NCT ID: NCT02019641
Last Updated: 2023-06-27
Results Overview
The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Before and after 10 weeks
Results posted on
2023-06-27
Participant Flow
Of the 46 subjects consented, 11 subjects met exclusion and one self-withdrew prior to randomization.
Participant milestones
| Measure |
Aerobic Exercise Intervention (AET+)
Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks
|
Control Group (CON)
Participant with interstitial lung disease performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks
|
Control Group (CON) Then AET
Participant with interstitial lung disease that crossed over from the control arm to perform aerobic exercise three times a week for 10 weeks
|
|---|---|---|---|
|
10-Week Follow up
STARTED
|
17
|
17
|
0
|
|
10-Week Follow up
COMPLETED
|
14
|
16
|
0
|
|
10-Week Follow up
NOT COMPLETED
|
3
|
1
|
0
|
|
20-Week Follow up
STARTED
|
0
|
0
|
15
|
|
20-Week Follow up
COMPLETED
|
0
|
0
|
14
|
|
20-Week Follow up
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Aerobic Exercise Intervention (AET+)
Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks
|
Control Group (CON)
Participant with interstitial lung disease performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks
|
Control Group (CON) Then AET
Participant with interstitial lung disease that crossed over from the control arm to perform aerobic exercise three times a week for 10 weeks
|
|---|---|---|---|
|
10-Week Follow up
Withdrawal by investigator
|
2
|
0
|
0
|
|
10-Week Follow up
Withdrawal by Subject
|
1
|
1
|
0
|
|
20-Week Follow up
Withdrawal by investigator
|
0
|
0
|
1
|
Baseline Characteristics
The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease
Baseline characteristics by cohort
| Measure |
Aerobic Exercise Intervention (AET+)
n=17 Participants
Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks
|
Control Group (CON)
n=17 Participants
Participant with interstitial lung disease performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and after 10 weeksPopulation: The analyses included only those subjects who completed the 6MWT at both time points (baseline and after 10-weeks)
The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).
Outcome measures
| Measure |
Aerobic Exercise Intervention (AET+)
n=14 Participants
Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks
|
Control Group (CON)
n=16 Participants
Participant with interstitial lung disease performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks
|
|---|---|---|
|
Change in 6-minute Walk Test Distance (6MWD)
|
46.5 Meters
Standard Deviation 35.8
|
23.2 Meters
Standard Deviation 38.6
|
Adverse Events
Aerobic Exercise Intervention (AET+)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group (CON)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (CON) Then AET
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Aerobic Exercise Intervention (AET+)
n=17 participants at risk
Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks
|
Control Group (CON)
n=17 participants at risk
Participant with interstitial lung disease performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks
|
Control Group (CON) Then AET
n=15 participants at risk
Participant with interstitial lung disease that crossed over from the control arm to perform aerobic exercise three times a week for 10 weeks
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
5.9%
1/17 • 6 months
|
0.00%
0/17 • 6 months
|
6.7%
1/15 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • 6 months
|
0.00%
0/17 • 6 months
|
6.7%
1/15 • 6 months
|
Other adverse events
| Measure |
Aerobic Exercise Intervention (AET+)
n=17 participants at risk
Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks
|
Control Group (CON)
n=17 participants at risk
Participant with interstitial lung disease performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks
|
Control Group (CON) Then AET
n=15 participants at risk
Participant with interstitial lung disease that crossed over from the control arm to perform aerobic exercise three times a week for 10 weeks
|
|---|---|---|---|
|
Cardiac disorders
Ventricular arrhythmia
|
5.9%
1/17 • 6 months
|
0.00%
0/17 • 6 months
|
0.00%
0/15 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place