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Capnometry-Assisted Breathing Training for COPD (CATCH)

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ClinicalTrials.gov Identifier: NCT03457103
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) Behavioral: Pulmonary Rehabilitation (PR) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Capnometry-Assisted Breathing Training for COPD
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 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
Behavioral: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)
Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.

Behavioral: 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).

Active Comparator: Control Group
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
Behavioral: 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).




Primary Outcome Measures :
  1. peak VO2(ml/kg/minand % predicted based on age) to measure exercise capacity Pre-Treatment [ Time Frame: Day 1 ]
  2. peak VO2(ml/kg/minand % predicted based on age) to measure exercise capacity Post-Treatment [ Time Frame: Week 10 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD as defined by FEV1/FVC of < 0.70 on a flow volume loop, or as shown on a chest CT;
  • medically cleared to participate in NYULMC's pulmonary rehabilitation program;
  • English speaking.

Exclusion Criteria:

  • require 24-hour supplemental oxygen;
  • cognitive impairment as measured by ≤23/30 on the Mini Mental State Examination (MMSE)83;
  • lung cancer treated in the past 5 years;
  • morbid obesity (BMI > 40);
  • current smoking; and
  • unstable cardiac disease defined by a history of a myocardial infarction in the past 3 months. Patients who require hospitalization for an exacerbation or are unable to resume their PR program within 2 weeks following an exacerbation will be withdrawn from the trial.

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03457103     History of Changes
Other Study ID Numbers: 17-01672
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases