Capnometry-Assisted Breathing Training for COPD

Study Overview
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Brief Summary
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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.

Official Title
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Capnometry-Assisted Breathing Training for COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)
* Device: Pulmonary Rehabilitation (PR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CATCH Group<br>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)<br>* Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.<br>Device: Pulmonary Rehabilitation (PR)<br>* 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).<br>|
| Active Comparator: Control Group<br>Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program. | Device: Pulmonary Rehabilitation (PR)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adherence to Home Breathing Exercises |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 2 weeks pre intervention and 4 weeks post intervention | 
| Mean Difference in Heart Rate Maximum Between Pre and Post Intervention |  | 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. | 0 weeks and 10 weeks | 
| 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 | 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. | Week 0 and Week 10 |