Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Interventions
DEVICECapnometry-Assisted Training for COPD to Slow the Breath (CATCH)
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).
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 40 years of age * has COPD documented in their electronic medical record, as defined by FEV1/FVC of \< 0.70 on pulmonary function testing (spirometry), or as shown on a chest CT * Can maintain oxygen saturation (SaO2) ≥ 90% on room air at rest * Is medically cleared to participate in NYULMC's outpatient pulmonary rehabilitation program * English speaking. Pregnant patients will not be enrolled in the study
Exclusion criteria
* Requires 24-hour supplemental oxygen * Has cognitive impairment as measured by ≤23/30 on the Mini Mental State Examination (MMSE) * Is actively being treated for lung cancer (E.g. with chemotherapy or upcoming surgery) * Has morbid obesity (BMI \> 40) * Is currently smoking * Has unstable cardiac disease defined by a history of a myocardial infarction in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adherence to Home Breathing Exercises | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention | 2 weeks pre intervention and 4 weeks 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 |
| Mean Difference in Heart Rate Maximum Between Pre and Post Intervention | 0 weeks and 10 weeks | — |
| Difference in Mean 6MWT Distance Between Pre and Post Intervention | Week 0 and Week 10 | 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. |
| Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention | 0 weeks and 10 weeks | — |
| Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention | Week 0 and Week 10 | 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. |
| Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention | 0 weeks and 10 weeks | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 22 |
| 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). | 9 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | financial/ insurance issues | 1 | 1 |
| Overall Study | illness/hospitalization | 4 | 2 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | CATCH Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 10.45 | 72.1 years STANDARD_DEVIATION 9.03 | 71.4 years STANDARD_DEVIATION 7.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 28 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 24 Participants | 7 Participants |
| Region of Enrollment United States | 22 Participants | 31 Participants | 9 Participants |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 9 |
| other Total, other adverse events | 0 / 22 | 0 / 9 |
| serious Total, serious adverse events | 0 / 22 | 0 / 9 |
Outcome results
Primary
Number of Participants With Adherence to Home Breathing Exercises
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CATCH Group | Number of Participants With Adherence to Home Breathing Exercises | 10 Participants |
| Control Group | Number of Participants With Adherence to Home Breathing Exercises | 5 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CATCH Group | Difference in Mean 6MWT Distance Between Pre and Post Intervention | 39.37 meters |
| Control Group | Difference in Mean 6MWT Distance Between Pre and Post Intervention | 24.99 meters |
Secondary
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
Population: -3.16 (-8.89, 2.57)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CATCH Group | 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) |
| Control Group | Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention | -3.16 score on DMQ-CAT (Anxiety) |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CATCH Group | Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention | -4.18 score on PROMIS questionnaire |
| Control Group | Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention | 5.2 score on PROMIS questionnaire |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CATCH Group | Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention | -11.76 score on SGRQ questionnaire |
| Control Group | Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention | -9.96 score on SGRQ questionnaire |
Secondary
Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
Time frame: 0 weeks and 10 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CATCH Group | Mean Difference in Heart Rate Maximum Between Pre and Post Intervention | 6.2 beats per minute |
| Control Group | Mean Difference in Heart Rate Maximum Between Pre and Post Intervention | 3 beats per minute |
Secondary
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
Time frame: 0 weeks and 10 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CATCH Group | Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention | -2.75 Breaths per minute |
| Control Group | Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention | -4.2 Breaths per minute |