Capnography-Assisted Learned, Monitored (CALM) Breathing Therapy for COPD

二氧化碳图辅助学习监测 (CALM) 呼吸治疗 COPD

基本信息

批准号：
10460026
负责人：
Anna Migliore Norweg
金额：
$ 38.32万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10460026
关键词：
Acute Adherence Adult Air Air Movements American Anxiety Anxiety Disorders Arousal Asphyxia Asthma Awareness Belief Benchmarking Biofeedback Biological Markers Breathing Breathing Exercises Capnography Carbon Dioxide Caring Cause of Death Chronic Obstructive Airway Disease Clinical Control Groups Data Devices Dropout Dyspnea Dyspnea Management Education Emotional Ensure Exercise Exhalation Failure Feedback Fright Functional disorder Future Health High Prevalence Home Hour Hunger Hypercapnia Hypersensitivity Impairment Individual Interoception Intervention Interview Lead Learning Life Light Link Lip structure Lung Measures Mechanics Mediator of activation protein Mental Depression Mind-Body Intervention Monitor Movement Nose Outcome Outpatients Oxygen Panic Panic Disorder Participant Patient Recruitments Patients Pattern Perception Pharmacotherapy Physical activity Physiological Physiology Population Posture Protocols documentation Public Health Pump Quality of life Randomized Randomized Clinical Trials Readiness Recovery Regulation Research Respiratory Mechanics Rest Risk Self Efficacy Self Management Signal Transduction Single-Blind Study Stimulus Stretching Structure Symptoms Target Populations Testing Time Tissues Trust Visualization Waiting Lists Walking Well in self acceptability and feasibility adherence rate airway obstruction anxiety sensitivity anxiety symptoms base behavior change conditioned fear design disability efficacy trial exercise intolerance exercise prescription exercise training experience feasibility testing follow-up functional disability improved indexing innovation meetings motivated behavior novel novel strategies persistent symptom primary outcome programs pulmonary function pulmonary rehabilitation recruit respiratory response satisfaction standard of care success trait treatment adherence uptake ventilation

项目摘要

Project Summary/Abstract Chronic obstructive pulmonary disease (COPD) is characterized by increased dyspnea (uncomfortable, labored breathing) and anxiety, and low physical activity (PA) levels. Breathing ensures adequate supply of oxygen to tissues, and just as important, maintains carbon dioxide (CO2) levels in a narrow range. Both COPD and anxiety cause dysfunctional breathing patterns (e.g., rapid, effortful, irregular breathing), which contribute to abnormal levels of CO2. But current pulmonary rehabilitation (PR) protocols do not address the breathing irregularity and anxiety simultaneously. Rapid, shallow breathing in severe COPD allows insufficient time to empty the lungs, causing retention of CO2 (hypercapnia). Hypercapnia causes a vicious cycle of increased ventilation, dyspnea and panic, increasing the risk of ventilatory pump failure. We designed a high priority, novel mind-body intervention called Capnography-Assisted Learned, Monitored (CALM) Breathing, which targets CO2 levels (eucapnic breathing) through real-time end-tidal CO2 (ETCO2), respiratory rate (RR), and airflow pattern biofeedback. CALM Breathing promotes slow, efficient breathing mechanics, interoceptive function, and dyspnea self-efficacy to relieve dyspnea and anxiety. Biofeedback simplifies physiological information through visualization to promote learning, nudge self-regulated breathing success, and optimize exercise prescription. CALM Breathing is a complementary intervention to standard of care pharmacotherapy and PR. The tailored 4-week CALM Breathing intervention pre-PR includes coaching and 10 core, slow breathing exercises performed at rest in recovery postures and with movement (ribcage stretches and brief ≤5- min light-moderate intensity PA) in eight, twice weekly, 1-hour sessions. Participants also perform audio- guided breathing exercises at home with a RR biofeedback device for adherence and quality checks. We will evaluate the feasibility and acceptability of CALM Breathing in a single-blind randomized clinical trial (RCT) with 40 adults with COPD and elevated anxiety sensitivity. Participants will be recruited from NYU Langone Health's outpatient pulmonary rehabilitation patient referral list and randomized into two groups: CALM Breathing and Wait-List. We will test feasibility based on participant recruitment efficiency and retention; CALM Breathing adherence rates and intervention fidelity scores; and facilitation of PR initiation by week 6–10. Acceptability will be evaluated based on CALM Breathing attendance, drop-out rate, satisfaction ratings, and themes derived from semi-structured interviews. Feasibility and acceptability results that meet a priori success benchmarks will support a future well-powered efficacy trial that measures dyspnea with activities and six- minute walk distance as primary outcomes; anxiety symptoms, PA, generic and COPD-specific quality of life, ETCO2 and RR, and lung function as secondary clinical outcomes; PR uptake and utilization; and interoceptive awareness, anxiety sensitivity, dyspnea self-efficacy, nasal symptoms, and depression as mediator variables. The innovative CALM Breathing intervention may lead to a fundamental paradigm shift in COPD treatment.

项目摘要/摘要慢性阻塞性肺疾病（COPD）的特征是呼吸困难增加（不舒服，呼吸）和焦虑症，体育活动（PA）水平较低。呼吸可确保足够的供应氧气到组织，同样重要的是，将二氧化碳（CO2）水平保持在狭窄范围内。两者copd 焦虑会导致功能失调的呼吸模式（例如，快速，高效，不规则呼吸），这有助于二氧化碳水平异常。但是当前的肺康复（PR）方案无法解决呼吸不规则和焦虑。在严重的COPD中快速，浅呼吸允许的时间不足清空肺部，导致二氧化碳（Hypercapnia）保留。高碳酸血症会导致恶性循环增加通风，呼吸困难和恐慌，增加了通气泵故障的风险。我们设计了一个很高的优先事项，新颖的思维体干预称为循环辅助辅助，受到监测（平静）呼吸，通过实时末端潮汐CO2（ETCO2），呼吸速率（RR）和气流模式生物反馈。平静的呼吸可促进缓慢，高效的呼吸机制，互感功能，以及呼吸困难的自我效能感，以挽救呼吸困难和焦虑。 Biofback简化了生理通过可视化信息以促进学习，轻推自调节的呼吸成功并优化运动处方。平静呼吸是对护理药物标准药物治疗的完整干预和PR。量身定制的4周平静呼吸干预PREPR包括教练和10个核心，缓慢在恢复姿势和运动中进行的休息时进行呼吸运动（胸腔拉伸和短暂≤5-- 最小的轻度强度PA）在八次，每周两次，1小时。参与者还执行音频 - 带有RR Biofeack Back设备在家中进行指导呼吸练习，以依从性和质量检查。我们将评估单盲随机临床试验（RCT）中平静呼吸的可行性和可接受性有40名具有COPD的成年人和升高的动画敏感性。参与者将从NYU Langone招募健康的门诊肺康复患者转诊清单，并随机分为两组：平静呼吸和等待名单。我们将根据参与者的招聘效率和保留率测试可行性；冷静的呼吸依从性率和干预忠诚度得分；并在第6-10周之前促进PR计划。可接受性将根据平静的呼吸出勤，辍学率，满意度等级以及从半结构化访谈得出的主题。可行性和可接受性结果符合先验成功基准测试将支持一项未来能力强大的效率试验，该试验通过活动和六个步行距离，作为主要结果；焦虑症状，PA，通用和COPD特定的生活质量， ETCO2和RR，肺功能充当次级临床结果； PR吸收和利用；和互感意识，焦虑敏感性，呼吸困难自我有效，鼻符号和抑郁症作为中介变量。创新的平静呼吸干预可能会导致COPD治疗的根本范式转变。