Trial Outcomes & Findings for Reducing Dynamic Hyperinflation Through Breathing Retraining (NCT NCT01009099)
NCT ID: NCT01009099
Last Updated: 2015-02-18
Results Overview
The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
119 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2015-02-18
Participant Flow
Patients were recruited from a midwestern VA hospital and were also referred from other patients and private practices.
204 patients signed informed consents and were screened for participation in the study. 85 patients did not meet eligibility criteria for the following reasons: PFT results did not meet study criteria, claudication, cardiac issues, non-compliance, changed their mind, and active substance use. 119 patients were enrolled in the protocol.
Participant milestones
| Measure |
Exercise Training With Breathing Retraining
treadmill exercise training plus breathing retraining using a metranome
|
Exercise Training
treadmill exercise training
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
61
|
|
Overall Study
COMPLETED
|
53
|
57
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Exercise Training With Breathing Retraining
treadmill exercise training plus breathing retraining using a metranome
|
Exercise Training
treadmill exercise training
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Reducing Dynamic Hyperinflation Through Breathing Retraining
Baseline characteristics by cohort
| Measure |
Arm 1
n=58 Participants
exercise training with breathing retraining
breathing retraining: breathing retraining using a metronome
exercise training: treadmill exercise training
|
Arm 2
n=61 Participants
exercise training
exercise training: treadmill exercise training
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
66.3 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
66.0 years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=99 Participants
|
61 participants
n=107 Participants
|
119 participants
n=206 Participants
|
|
Body Mass Index
|
30.0 kg/m2
STANDARD_DEVIATION 6.7 • n=99 Participants
|
29.3 kg/m2
STANDARD_DEVIATION 6.2 • n=107 Participants
|
29.7 kg/m2
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
FEV1
|
43.7 percent predicted
STANDARD_DEVIATION 14.9 • n=99 Participants
|
44.0 percent predicted
STANDARD_DEVIATION 13.9 • n=107 Participants
|
43.8 percent predicted
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
FEV1/FVC
|
46.6 percent
STANDARD_DEVIATION 13.3 • n=99 Participants
|
45.1 percent
STANDARD_DEVIATION 12.1 • n=107 Participants
|
45.8 percent
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
RV/TLC
|
171.3 percent predicted
STANDARD_DEVIATION 30.3 • n=99 Participants
|
168.2 percent predicted
STANDARD_DEVIATION 26.6 • n=107 Participants
|
169.7 percent predicted
STANDARD_DEVIATION 28.4 • n=206 Participants
|
|
Peak oxygen uptake
|
15.7 VO2 mL/kg/min
STANDARD_DEVIATION 3.9 • n=99 Participants
|
16.6 VO2 mL/kg/min
STANDARD_DEVIATION 3.3 • n=107 Participants
|
16.1 VO2 mL/kg/min
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Time on treadmill constant workrate test
|
6.8 minutes walked
STANDARD_DEVIATION 2.5 • n=99 Participants
|
6.9 minutes walked
STANDARD_DEVIATION 2.3 • n=107 Participants
|
6.9 minutes walked
STANDARD_DEVIATION 2.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Patients who completed 12 weeks of exercise training were analyzed. There was one patient in each group that did not complete the treadmill test at 12 weeks although they completed other secondary outcome measures. Although they did not complete this measure, they remained in the study and were not counted as a drop.
The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.
Outcome measures
| Measure |
Exercise Training With Breathing Retraining
n=52 Participants
treadmill exercise training plus breathing retraining using a metranome
|
Exercise Training
n=56 Participants
treadmill exercise training
|
|---|---|---|
|
Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)
|
15.2 minutes
Standard Deviation 14.8
|
17.6 minutes
Standard Deviation 14.1
|
Adverse Events
Exercise Training With Breathing Retraining
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Exercise Training
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise Training With Breathing Retraining
n=58 participants at risk
treadmill exercise training plus breathing retraining using a metranome
|
Exercise Training
n=61 participants at risk
treadmill exercise training
|
|---|---|---|
|
Nervous system disorders
ischemic cerebrovascular
|
0.00%
0/58 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
3.3%
2/61 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
|
Musculoskeletal and connective tissue disorders
fracture
|
1.7%
1/58 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
0.00%
0/61 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
|
Musculoskeletal and connective tissue disorders
pain
|
0.00%
0/58 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
1.6%
1/61 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
|
Vascular disorders
arterial injury-extremity lower
|
0.00%
0/58 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
1.6%
1/61 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
|
Infections and infestations
infection peripheral nerve
|
0.00%
0/58 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
1.6%
1/61 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
Other adverse events
| Measure |
Exercise Training With Breathing Retraining
n=58 participants at risk
treadmill exercise training plus breathing retraining using a metranome
|
Exercise Training
n=61 participants at risk
treadmill exercise training
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
3.4%
2/58 • Number of events 2 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
8.2%
5/61 • Number of events 6 • Adverse events were collected over 6 months (baseline through end of study or 6 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place