Capnometry-Assisted Breathing Training for COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants With Adherence to Home Breathing Exercises
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) (Device)
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
干预措施: Pulmonary Rehabilitation (PR) (Device)
Control Group
Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.
干预措施: Pulmonary Rehabilitation (PR) (Device)
结局指标
主要结局
Number of Participants With Adherence to Home Breathing Exercises
时间窗: Day 1
次要结局
- Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention(0 weeks and 10 weeks)
- Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention(2 weeks pre intervention and 4 weeks post intervention)
- Difference in Mean PROMIS Fatigue Score 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(Week 0 and Week 10)
- Difference in Mean 6MWT Distance Between Pre and Post Intervention(Week 0 and Week 10)
- Mean Difference in Heart Rate Maximum Between Pre and Post Intervention(0 weeks and 10 weeks)