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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CATCH Group | Experimental | 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 |
|
| Control Group | Active Comparator | Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) | Device | Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adherence to Home Breathing Exercises | Day 1 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Maria Norweg, MD | NYU Langone Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36800224 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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). |
| FG001 | Control Group | Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program. 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adherence to Home Breathing Exercises | Posted | Count of Participants | Participants | Day 1 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Norweg | NYU Langone | 646-501-7777 | AnnaMaria.Norweg@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2019 | Jun 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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). |
|
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 |
| Withdrawal by Subject |
|
| financial/ insurance issues |
|
| BG001 | Control Group | Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program. 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control Group | Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program. 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). |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | meters | 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 | -3.16 (-8.89, 2.57) | Posted | Mean | 95% Confidence Interval | score on DMQ-CAT (Anxiety) | 2 weeks pre intervention and 4 weeks post intervention |
|
|
|
| Secondary | Mean Difference in Heart Rate Maximum Between Pre and Post Intervention | Posted | Mean | 95% Confidence Interval | beats per minute | 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. | Posted | Mean | 95% Confidence Interval | score on PROMIS questionnaire | 0 weeks and 10 weeks |
|
|
|
| Secondary | Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention | Posted | Mean | 95% Confidence Interval | Breaths per minute | 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. | Posted | Mean | 95% Confidence Interval | score on SGRQ questionnaire | Week 0 and Week 10 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control Group | Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program. 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). | 0 | 9 | 0 | 9 | 0 | 9 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |