Capnometry-Assisted Breathing Training for COPD (CATCH)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH); Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.; Device: 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).
Active Comparator: Control Group; Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Study Director: Anna Maria Norweg, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2015
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 17-01672

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No