Capnometry-Assisted Breathing Training for COPD

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH); Device: Pulmonary Rehabilitation (PR)

• Registration Number: NCT03457103
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-16
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-07
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Results First Submitted: 2021-06-08
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Results First Posted: 2021-08-18
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CATCH Group	Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)	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
Control Group	Pulmonary Rehabilitation (PR)	Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
CATCH Group	Pulmonary Rehabilitation (PR)	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adherence to Home Breathing Exercises	Day 1

Secondary Outcome Measures

Name	Time	Method
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention	0 weeks and 10 weeks
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
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.
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 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 Heart Rate Maximum Between Pre and Post Intervention	0 weeks and 10 weeks

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States