Capnometry-Assisted Breathing Training for COPD

NCT ID: NCT03457103

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-16
• Study Completion Date: 2019-08-02

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)

Intervention Type: DEVICE

Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.

Pulmonary Rehabilitation (PR)

Intervention Type: DEVICE

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).

Control Group

Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.

Group Type: ACTIVE_COMPARATOR

Pulmonary Rehabilitation (PR)

Intervention Type: DEVICE

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).

Interventions

Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)

Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Maria Norweg, MD

Role: STUDY_DIRECTOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

References

Norweg AM, Wu Y, Troxel A, Whiteson JH, Collins E, Haas F, Skamai A, Goldring R, Jean-Louis G, Reibman J, Ehrlich-Jones L, Simon N. Mind-Body Intervention for Dysfunctional Breathing in Chronic Obstructive Pulmonary Disease: Feasibility Study and Lessons Learned. J Integr Complement Med. 2023 Mar;29(3):156-168. doi: 10.1089/jicm.2022.0552. Epub 2023 Feb 17.

Reference Type: DERIVED

PMID: 36800224 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-01672

Identifier Type: -

Identifier Source: org_study_id