Capnometry-Assisted Breathing Training for COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— CATCH  

Official title:

Capnometry-Assisted Breathing Training for COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457103
• Other study ID #: 17-01672
• Status: Completed
• Phase: Phase 2
• Start date: June 16, 2015
• Est. completion date: August 2, 2019

Study information

• Verified date: July 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adherence to Home Breathing Exercises		Day 1
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.	Week 0 and Week 10
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	2 weeks pre intervention and 4 weeks post intervention
Secondary	Mean Difference in Heart Rate Maximum Between Pre and Post Intervention		0 weeks and 10 weeks
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.	0 weeks and 10 weeks
Secondary	Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention		0 weeks and 10 weeks
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.	Week 0 and Week 10