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

• 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
• 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

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.

项目概要/摘要 慢性阻塞性肺疾病 (COPD) 的特点是呼吸困难加重（不舒服、 呼吸困难）和焦虑，以及体力活动（PA）水平低。呼吸保证充足的供给 为组织提供氧气，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。两者均为慢性阻塞性肺病 和焦虑会导致呼吸模式功能失调（例如，快速、费力、不规则的呼吸），从而导致 二氧化碳浓度异常。但目前的肺康复 (PR) 方案并未解决呼吸问题 不规律和焦虑同时发生。严重慢性阻塞性肺病患者呼吸快而浅，没有足够的时间 排空肺部，导致二氧化碳滞留（高碳酸血症）。高碳酸血症会导致血容量增加的恶性循环 通气、呼吸困难和恐慌，增加通气泵故障的风险。我们设计了一个高优先级， 称为二氧化碳图辅助学习、监测（CALM）呼吸的新型身心干预措施， 通过实时呼气末二氧化碳 (ETCO2)、呼吸频率 (RR) 和 气流模式生物反馈。 CALM 呼吸促进缓慢、高效的呼吸机制、内感受 功能和呼吸困难自我效能，以缓解呼吸困难和焦虑。生物反馈简化生理 通过可视化提供信息来促进学习、推动自我调节呼吸成功并优化 运动处方。 CALM 呼吸是标准护理药物治疗的补充干预措施 和公关。公关前量身定制的为期 4 周的 CALM 呼吸干预包括辅导和 10 项核心缓慢呼吸训练 在休息、恢复姿势和运动时进行的呼吸练习（胸腔伸展和短暂的≤5- 分钟光-中等强度 PA），每周两次，每次 1 小时，共 8 次。参与者还表演音频 使用 RR 生物反馈设备在家引导呼吸练习，以进行依从性和质量检查。我们将 在单盲随机临床试验 (RCT) 中评估 CALM 呼吸的可行性和可接受性 与 40 名患有慢性阻塞性肺病且焦虑敏感性升高的成年人合作。参与者将从纽约大学朗格尼分校招募 Health 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来测试可行性；冷静的 呼吸依从率和干预保真度评分；并在第 6-10 周促进 PR 启动。 可接受性将根据 CALM Breathing 出勤率、辍学率、满意度评分和 来自半结构化访谈的主题。满足先验成功的可行性和可接受性结果 基准将支持未来强有力的功效试验，通过活动和六项措施来衡量呼吸困难 分钟步行距离作为主要结果；焦虑症状、PA、一般和 COPD 特定的生活质量、 ETCO2 和 RR 以及肺功能作为次要临床结果；公关的吸收和利用；和内感受 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 CALM 呼吸干预可能会导致慢性阻塞性肺病治疗的根本范式转变。