Trial Outcomes & Findings for Sustainability of Pulmonary Rehab Gains (NCT NCT02241733)
NCT ID: NCT02241733
Last Updated: 2019-10-03
Results Overview
Patients walk on a treadmill set at a constant workrate. The difference in the time walked on the treadmill from baseline to study completion is the primary outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
52 week test
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
Exercise
Patients exercised for 12 weeks and then participated in an adherence program
Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program.
|
Exercise Plus Breathing Retraining
Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program
Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
25
|
30
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
| Measure |
Exercise
Patients exercised for 12 weeks and then participated in an adherence program
Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program.
|
Exercise Plus Breathing Retraining
Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program
Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
4
|
|
Overall Study
Physician Decision
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
Sustainability of Pulmonary Rehab Gains
Baseline characteristics by cohort
| Measure |
Exercise
n=40 Participants
Patients will exercise for 12 weeks and then participate in an adherence program
Exercise only: Patients will participate in a 12-week exercise program . They will also participate in an adherence program.
|
Exercise Plus Breathing Retraining
n=40 Participants
Patients will exercise plus breathing retraining for 12 weeks and then participate in an adherence program
Breathing retraining plus exercise: Patients will participate in a 12-week exercise program with breathing retraining. They will also participate in an adherence program.
|
Total
n=80 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
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 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
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 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
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Time walked on constant workload treadmill test
|
7.2 minutes walked
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7.1 minutes walked
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.2 minutes walked
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Inspiratory capacity
|
2.09 liters
STANDARD_DEVIATION .69 • n=5 Participants
|
1.88 liters
STANDARD_DEVIATION .49 • n=7 Participants
|
1.99 liters
STANDARD_DEVIATION .59 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 week testPopulation: A multiple imputation model was used to impute missing values for those who did not complete the 52 weeks of the program.
Patients walk on a treadmill set at a constant workrate. The difference in the time walked on the treadmill from baseline to study completion is the primary outcome measure.
Outcome measures
| Measure |
Exercise
n=40 Participants
Patients exercised for 12 weeks and then participated in an adherence program
Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program.
|
Exercise Plus Breathing Retraining
n=40 Participants
Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program
Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program.
|
|---|---|---|
|
Duration of Exercise Time on a Constant Work-rate Treadmill Test
|
12.2 change in number of minutes walked
Standard Deviation 3.5
|
12.5 change in number of minutes walked
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 52 week testPopulation: A multiple imputation model was used to impute values for those who did not complete the program. The score below is the difference between 52 weeks and baseline.
Inspiratory capacity is measured at a set time during the constant workrate treadmill test. The difference between the inspiratory capacity measured at baseline and 52 weeks is a secondary outcome. Inspiratory capacity measured during exercise is a measure of dynamic hyperinflation.
Outcome measures
| Measure |
Exercise
n=40 Participants
Patients exercised for 12 weeks and then participated in an adherence program
Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program.
|
Exercise Plus Breathing Retraining
n=40 Participants
Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program
Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program.
|
|---|---|---|
|
Inspiratory Capacity
|
-0.02 difference in liters inspired
Standard Deviation .07
|
.15 difference in liters inspired
Standard Deviation .07
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Multiple imputation procedures were used to impute data for those that did not complete the protocol
Six-minute walk distance will be measured at 52 weeks. The difference in distance walked in meters between baseline and 52 weeks is the secondary outcome measure. The 6 minute walk is conducted using the guidelines issued by the American Thoracic Society.
Outcome measures
| Measure |
Exercise
n=40 Participants
Patients exercised for 12 weeks and then participated in an adherence program
Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program.
|
Exercise Plus Breathing Retraining
n=40 Participants
Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program
Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program.
|
|---|---|---|
|
6 Minute Walk Distance
|
25.9 meters
Standard Deviation 8.5
|
22.8 meters
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Multiple imputation was used to impute missing values for those who did not complete the protocol.
Mastery over breathing is measured using the Chronic Respiratory Disease Questionnaire. Specifically the subscale 'mastery" is the investigators' secondary outcome. The difference in scores from baseline to 52 weeks is the investigators' outcome measure. The Chronic Respiratory Disease Questionnaire is a valid and reliable questionnaire. 1=minimum score, 7=maximum with the higher score indicating greater mastery. A higher score indicates better health. A change of 0.5 indicates a small change, 1.0 indicates a moderate change and greater or equal to a change of 1.5 indicates a large change.
Outcome measures
| Measure |
Exercise
n=40 Participants
Patients exercised for 12 weeks and then participated in an adherence program
Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program.
|
Exercise Plus Breathing Retraining
n=40 Participants
Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program
Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program.
|
|---|---|---|
|
Mastery Over Breathing
|
1.9 score on a scale
Standard Deviation 4.9
|
2.3 score on a scale
Standard Deviation 4.6
|
Adverse Events
Exercise
Serious events: 16 serious events
Other events: 0 other events
Deaths: 1 deaths
Exercise Plus Breathing Retraining
Serious events: 15 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Exercise
n=40 participants at risk
Patients exercised for 12 weeks and then participated in an adherence program
Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program.
|
Exercise Plus Breathing Retraining
n=40 participants at risk
Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program
Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
32.5%
13/40 • Number of events 15 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
27.5%
11/40 • Number of events 11 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Gastrointestinal disorders
Rectal abscess
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Renal and urinary disorders
Kidney stones
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Nervous system disorders
brain aneurysm
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Blood and lymphatic system disorders
cellulitis
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Nervous system disorders
meningioma
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Blood and lymphatic system disorders
leukemia
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
|
Vascular disorders
stroke
|
0.00%
0/40 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
|
Other adverse events
Adverse event data not reported
Additional Information
Eileen Collins RN, PhD, Research Nurse Scientist
Edward Hines Jr., VA Hospital
Phone: 312-413-5621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place