A Phase 2 interventional study of Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) and Pulmonary Rehabilitation (PR) in Chronic Obstructive Pulmonary Disease, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
Capnometry-Assisted Breathing Training for COPD (CATCH) is a behavioral intervention that aims to promote optimal, self-regulated, mindful breathing. A portable capnometer is used in-session to provide continuous visual feedback of Respiratory Rate (RR), End-Tidal Carbon Dioxide Tension (ETCO2), and breathing pattern. The tailored CATCH intervention will emphasize a slow, quiet, regular, nasal breathing pattern, as well as pursed lips breathing (PLB). CATCH is once weekly for 6 weeks, for a total of 6 sessions; each session is approximately 60 minutes long. The principal investigator will implement the CATCH intervention. The principal investigator will implement the CATCH intervention. Patients will use the Address Stress app on a smart phone or computer tablet as part of their home breathing exercises.
Exclusion Criteria:
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
Device: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) · Device: Pulmonary Rehabilitation (PR)
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Device: Pulmonary Rehabilitation (PR)
Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
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).
Number of Participants With Adherence to Home Breathing Exercises
Time frame: Day 1
Difference in Mean 6MWT Distance Between Pre and Post Intervention
The 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.
Time frame: Week 0 and Week 10
Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention
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
Time frame: 2 weeks pre intervention and 4 weeks post intervention
Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
Time frame: 0 weeks and 10 weeks
Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue.
Time frame: 0 weeks and 10 weeks
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
Time frame: 0 weeks and 10 weeks
Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention
Disease-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.
Time frame: Week 0 and Week 10
| Milestone | CATCH Group | Control Group |
|---|---|---|
| Started | 22 | 9 |
| Completed | 14 | 3 |
| Not completed | 8 | 6 |
| Withdrew: Illness/hospitalization | 4 | 2 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Financial/ insurance issues | 1 | 1 |
| Participants | CATCH Group | Control Group |
|---|---|---|
| Number of Participants With Adherence to Home Breathing Exercises | 10 | 5 |
The 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.
| meters | CATCH Group | Control Group |
|---|---|---|
| Difference in Mean 6MWT Distance Between Pre and Post Intervention | 39.37 (14.13 to 64.61) | 24.99 (-32.53 to 82.52) |
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
| score on DMQ-CAT (Anxiety) | CATCH Group | Control Group |
|---|---|---|
| Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention | 2.43 (.09 to 4.77) | -3.16 (-8.89 to 2.57) |
| beats per minute | CATCH Group | Control Group |
|---|---|---|
| Mean Difference in Heart Rate Maximum Between Pre and Post Intervention | 6.2 (-1.32 to 13.72) | 3 (-35.12 to 41.12) |
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue.
| score on PROMIS questionnaire | CATCH Group | Control Group |
|---|---|---|
| Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention | -4.18 (-8.16 to -0.21) | 5.2 (-21.39 to 31.79) |
| Breaths per minute | CATCH Group | Control Group |
|---|---|---|
| Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention | -2.75 (-7.56 to 2.05) | -4.2 (-26.26 to 17.87) |
Disease-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.
| score on SGRQ questionnaire | CATCH Group | Control Group |
|---|---|---|
| Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention | -11.76 (-19.68 to -3.83) | -9.96 (-38.07 to 18.14) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CATCH Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Control Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | CATCH Group | Control Group | Total |
|---|---|---|---|
| Mean | 72.8 ± 10.45 | 71.4 ± 7.62 | 72.1 ± 9.03 |
| Sex: Female, Male(Participants) | CATCH Group | Control Group | Total |
|---|---|---|---|
| Female | 14 | 4 | 18 |
| Male | 8 | 5 | 13 |
| Ethnicity (NIH/OMB)(Participants) | CATCH Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 19 | 9 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CATCH Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 2 | 7 |
| White | 17 | 7 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | CATCH Group | Control Group | Total |
|---|---|---|---|
| United States | 22 | 9 | 31 |
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