Capnography-Assisted Learned, Monitored (CALM) Breathing Therapy for COPD - Resubmission - 1

COPD 的二氧化碳图辅助学习监测 (CALM) 呼吸疗法 - 重新提交 - 1

• 批准号: 10058022
• 负责人: Anna Migliore Norweg
• 金额: $ 38.14万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-18 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10058022
• 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 environment; 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; Respiratory physiology; 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; adherence rate; airway obstruction; anxiety sensitivity; anxiety symptoms; base; behavior change; conditioned fear; design; disability; efficacy trial; exercise intolerance; exercise prescription; exercise training; experience; follow-up; functional disability; improved; indexing; innovation; meetings; motivated behavior; novel; novel strategies; persistent symptom; primary outcome; programs; pulmonary rehabilitation; recruit; respiratory; response; satisfaction; standard of care; success; trait; treatment adherence; uptake; ventilation

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.

项目总结/摘要 慢性阻塞性肺病（COPD）的特征是呼吸困难增加（不舒服， 呼吸困难）和焦虑，以及低体力活动（PA）水平。呼吸确保充足的 氧气供应给组织，同样重要的是，将二氧化碳（CO2）水平维持在一个狭窄的范围内。两种COPD 并且焦虑导致功能障碍的呼吸模式（例如，快速，费力，不规则的呼吸），这有助于 二氧化碳含量异常但目前的肺康复（PR）协议不解决呼吸 焦虑和焦虑同时存在。严重COPD患者的快速、浅呼吸使患者没有足够的时间 排空肺部，导致二氧化碳潴留（高碳酸血症）。高碳酸血症会导致一个恶性循环， 呼吸困难和恐慌，增加了呼吸泵故障的风险。我们设计了一个高优先级， 一种新的身心干预方法，称为二氧化碳描记术辅助学习，自主呼吸（CALM）， 通过实时呼气末CO2（ETCO 2）、呼吸频率（RR）来确定CO2水平（正常二氧化碳呼吸），以及 气流模式生物反馈平静的呼吸促进缓慢，有效的呼吸机制， 功能和呼吸困难自我效能，以缓解呼吸困难和焦虑。生物反馈简化了生理 通过可视化信息，以促进学习，推动自我调节呼吸的成功，并优化 运动处方平静呼吸是标准药物治疗的补充干预措施 量身定制的4周平静呼吸干预预公关包括教练和10个核心，缓慢 在休息时以恢复姿势和运动进行呼吸练习（胸廓伸展和简短≤5- 分8次，每周2次，每次1小时。参与者还执行音频- 在家中使用RR生物反馈设备进行指导性呼吸练习，以进行依从性和质量检查。我们将 在单盲随机临床试验（RCT）中评价CALM呼吸的可行性和可接受性 40名患有慢性阻塞性肺病和焦虑敏感性升高的成年人。参与者将从NYU Langone招募 健康的门诊肺康复患者转诊名单，并随机分为两组：CALM 呼吸和等待名单。我们将根据参与者招募效率和保留率测试可行性; 呼吸坚持率和干预保真度评分;以及在第6-10周促进PR启动。 可接受性将根据CALM呼吸出勤率、脱落率、满意度评级和 从半结构化访谈中衍生出的主题。满足先验成功的可行性和可接受性结果 基准将支持未来的有效性试验，该试验测量活动性呼吸困难， 分钟步行距离作为主要结局;焦虑症状、PA、一般和COPD特异性生活质量， ETCO 2和RR以及肺功能作为次要临床结局; PR摄取和利用;以及内感受性 意识、焦虑敏感性、呼吸困难自我效能、鼻部症状和抑郁作为中介变量。 创新的平静呼吸干预可能会导致COPD治疗的根本范式转变。