Back to resultsCapnometry-Assisted Breathing Training for COPD (CATCH)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)
Pulmonary Rehabilitation (PR)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CATCH Group
Control Group
Arm Description
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
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Outcomes
Primary Outcome Measures
Number of Participants With Adherence to Home Breathing Exercises
Secondary Outcome Measures
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.
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
Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
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.
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03457103
Brief Title
Capnometry-Assisted Breathing Training for COPD
Acronym
CATCH
Official Title
Capnometry-Assisted Breathing Training for COPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 16, 2015 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CATCH Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Intervention Type
Device
Intervention Name(s)
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)
Intervention Description
Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
Intervention Type
Device
Intervention Name(s)
Pulmonary Rehabilitation (PR)
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants With Adherence to Home Breathing Exercises
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Difference in Mean 6MWT Distance Between Pre and Post Intervention
Description
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.
Time Frame
Week 0 and Week 10
Title
Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention
Description
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
Time Frame
2 weeks pre intervention and 4 weeks post intervention
Title
Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
Time Frame
0 weeks and 10 weeks
Title
Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue.
Time Frame
0 weeks and 10 weeks
Title
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
Time Frame
0 weeks and 10 weeks
Title
Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention
Description
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.
Time Frame
Week 0 and Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Maria Norweg, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Director
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Capnometry-Assisted Breathing Training for COPD
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