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Completed

NCT Number: NCT03457103

Capnometry-Assisted Breathing Training for COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Pulmonary Rehabilitation (PR)

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).

Primary outcomes

  1. Number of Participants With Adherence to Home Breathing Exercises

    Time frame: Day 1

Secondary outcomes

  1. Difference in Mean 6MWT Distance Between Pre and Post Intervention

    Time frame: 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.

  2. Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention

    Time frame: 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

  3. Mean Difference in Heart Rate Maximum Between Pre and Post Intervention

    Time frame: 0 weeks and 10 weeks

  4. Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention

    Time frame: 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.

  5. Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention

    Time frame: 0 weeks and 10 weeks

  6. Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Acronym: CATCH

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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