Trial Outcomes & Findings for Capnometry-Assisted Breathing Training for COPD (NCT NCT03457103)
NCT ID: NCT03457103
Last Updated: 2021-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Day 1
Results posted on
2021-08-18
Participant Flow
Participant milestones
| Measure |
CATCH Group
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
9
|
|
Overall Study
COMPLETED
|
14
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
CATCH Group
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
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|---|---|---|
|
Overall Study
illness/hospitalization
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
financial/ insurance issues
|
1
|
1
|
Baseline Characteristics
Capnometry-Assisted Breathing Training for COPD
Baseline characteristics by cohort
| Measure |
CATCH Group
n=22 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=9 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 10.45 • n=39 Participants
|
71.4 years
STANDARD_DEVIATION 7.62 • n=41 Participants
|
72.1 years
STANDARD_DEVIATION 9.03 • n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 1Outcome measures
| Measure |
CATCH Group
n=14 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=5 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
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|---|---|---|
|
Number of Participants With Adherence to Home Breathing Exercises
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 10The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Outcome measures
| Measure |
CATCH Group
n=12 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=4 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
|---|---|---|
|
Difference in Mean 6MWT Distance Between Pre and Post Intervention
|
39.37 meters
Interval 14.13 to 64.61
|
24.99 meters
Interval -32.53 to 82.52
|
SECONDARY outcome
Timeframe: 2 weeks pre intervention and 4 weeks post interventionPopulation: -3.16 (-8.89, 2.57)
The DMQ-CAT Dyspnea Anxiety is a 14 item scale; each item is scored off a 7 point likert scale for a total range of 0 to 98 where higher scores correlate with higher anxiety
Outcome measures
| Measure |
CATCH Group
n=13 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=3 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
|---|---|---|
|
Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention
|
2.43 score on DMQ-CAT (Anxiety)
Interval 0.09 to 4.77
|
-3.16 score on DMQ-CAT (Anxiety)
Interval -8.89 to 2.57
|
SECONDARY outcome
Timeframe: 0 weeks and 10 weeksOutcome measures
| Measure |
CATCH Group
n=10 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=2 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
|---|---|---|
|
Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
|
6.2 beats per minute
Interval -1.32 to 13.72
|
3 beats per minute
Interval -35.12 to 41.12
|
SECONDARY outcome
Timeframe: 0 weeks and 10 weeksPatient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue.
Outcome measures
| Measure |
CATCH Group
n=13 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=3 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
|---|---|---|
|
Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention
|
-4.18 score on PROMIS questionnaire
Interval -8.16 to -0.21
|
5.2 score on PROMIS questionnaire
Interval -21.39 to 31.79
|
SECONDARY outcome
Timeframe: 0 weeks and 10 weeksOutcome measures
| Measure |
CATCH Group
n=10 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=2 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
|---|---|---|
|
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
|
-2.75 Breaths per minute
Interval -7.56 to 2.05
|
-4.2 Breaths per minute
Interval -26.26 to 17.87
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Outcome measures
| Measure |
CATCH Group
n=12 Participants
A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
Control Group
n=3 Participants
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
|
|---|---|---|
|
Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention
|
-11.76 score on SGRQ questionnaire
Interval -19.68 to -3.83
|
-9.96 score on SGRQ questionnaire
Interval -38.07 to 18.14
|
Adverse Events
CATCH Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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