Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-25 @ 5:00 PM
Study NCT ID:
NCT03457103
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2018-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Capnometry-Assisted Breathing Training for COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AnnaMaria.Norweg@nyulangone.org', 'phone': '646-501-7777', 'title': 'Dr. Anna Norweg', 'organization': 'NYU Langone'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adherence to Home Breathing Exercises', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Mean 6MWT Distance Between Pre and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '39.37', 'groupId': 'OG000', 'lowerLimit': '14.13', 'upperLimit': '64.61'}, {'value': '24.99', 'groupId': 'OG001', 'lowerLimit': '-32.53', 'upperLimit': '82.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 10', '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.', 'unitOfMeasure': 'meters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.43', 'groupId': 'OG000', 'lowerLimit': '.09', 'upperLimit': '4.77'}, {'value': '-3.16', 'groupId': 'OG001', 'lowerLimit': '-8.89', 'upperLimit': '2.57'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks pre intervention and 4 weeks 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', 'unitOfMeasure': 'score on DMQ-CAT (Anxiety)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '-3.16 (-8.89, 2.57)'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Heart Rate Maximum Between Pre and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '13.72'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-35.12', 'upperLimit': '41.12'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks and 10 weeks', 'unitOfMeasure': 'beats per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.18', 'groupId': 'OG000', 'lowerLimit': '-8.16', 'upperLimit': '-0.21'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '-21.39', 'upperLimit': '31.79'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks and 10 weeks', '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.', 'unitOfMeasure': 'score on PROMIS questionnaire', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.75', 'groupId': 'OG000', 'lowerLimit': '-7.56', 'upperLimit': '2.05'}, {'value': '-4.2', 'groupId': 'OG001', 'lowerLimit': '-26.26', 'upperLimit': '17.87'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks and 10 weeks', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.76', 'groupId': 'OG000', 'lowerLimit': '-19.68', 'upperLimit': '-3.83'}, {'value': '-9.96', 'groupId': 'OG001', 'lowerLimit': '-38.07', 'upperLimit': '18.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 10', '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.', 'unitOfMeasure': 'score on SGRQ questionnaire', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'illness/hospitalization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'financial/ insurance issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CATCH Group', '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\n\nCapnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.\n\nPulmonary 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).'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.\n\nPulmonary 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).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '10.45', 'groupId': 'BG000'}, {'value': '71.4', 'spread': '7.62', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '9.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-14', 'size': 561157, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-01T15:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2018-03-01', 'resultsFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-26', 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adherence to Home Breathing Exercises', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Difference in Mean 6MWT Distance Between Pre and Post Intervention', 'timeFrame': 'Week 0 and Week 10', '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.'}, {'measure': 'Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention', 'timeFrame': '2 weeks pre intervention and 4 weeks 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'}, {'measure': 'Mean Difference in Heart Rate Maximum Between Pre and Post Intervention', 'timeFrame': '0 weeks and 10 weeks'}, {'measure': 'Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention', 'timeFrame': '0 weeks and 10 weeks', '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.'}, {'measure': 'Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention', 'timeFrame': '0 weeks and 10 weeks'}, {'measure': "Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention", 'timeFrame': 'Week 0 and Week 10', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '36800224', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* over 40 years of age\n* 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\n* Can maintain oxygen saturation (SaO2) ≥ 90% on room air at rest\n* Is medically cleared to participate in NYULMC's outpatient pulmonary rehabilitation program\n* English speaking. Pregnant patients will not be enrolled in the study\n\nExclusion Criteria:\n\n* Requires 24-hour supplemental oxygen\n* Has cognitive impairment as measured by ≤23/30 on the Mini Mental State Examination (MMSE)\n* Is actively being treated for lung cancer (E.g. with chemotherapy or upcoming surgery)\n* Has morbid obesity (BMI \\> 40)\n* Is currently smoking\n* Has unstable cardiac disease defined by a history of a myocardial infarction in the past 3 months"}, 'identificationModule': {'nctId': 'NCT03457103', 'acronym': 'CATCH', 'briefTitle': 'Capnometry-Assisted Breathing Training for COPD', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Capnometry-Assisted Breathing Training for COPD', 'orgStudyIdInfo': {'id': '17-01672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CATCH Group', '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', 'interventionNames': ['Device: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)', 'Device: Pulmonary Rehabilitation (PR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.', 'interventionNames': ['Device: Pulmonary Rehabilitation (PR)']}], 'interventions': [{'name': 'Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)', 'type': 'DEVICE', 'description': 'Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.', 'armGroupLabels': ['CATCH Group']}, {'name': 'Pulmonary Rehabilitation (PR)', 'type': 'DEVICE', '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).', 'armGroupLabels': ['CATCH Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Anna Maria Norweg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}