Norweg Anna, Hofferber Brittany, Oh Cheongeun, Spinner Michael, Stavrolakes Kimberly, Pavol Marykay, DiMango Angela, Raveis Victoria H, Murphy Charles G, Allegrante John P, Buchholz David, Zarate Alejandro, Simon Naomi
Department of Rehabilitation and Regenerative Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Department of Rehabilitation and Regenerative Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Contemp Clin Trials. 2023 Nov;134:107340. doi: 10.1016/j.cct.2023.107340. Epub 2023 Sep 18.
Although dyspnea is a primary symptom of chronic obstructive pulmonary disease (COPD), its treatment is suboptimal. In both COPD and acute anxiety, breathing patterns become dysregulated, contributing to abnormal CO, dyspnea, and inefficient recovery from breathing challenges. While pulmonary rehabilitation (PR) improves dyspnea, only 1-2% of patients access it. Individuals with anxiety who use PR have worse outcomes.
We present the protocol of a randomized controlled trial designed to determine the feasibility and acceptability of a new, four-week mind-body intervention that we developed, called "Capnography-Assisted Learned, Monitored (CALM) Breathing," as an adjunct to PR. Eligible participants are randomized in a 1:1 ratio to either CALM Breathing program or Usual Care. CALM Breathing consists of 10 core, slow breathing exercises combined with real time biofeedback (of end-tidal CO, respiratory rate, and airflow) and motivational interviewing. CALM Breathing promotes self-regulated breathing, linking CO changes to dyspnea and anxiety symptoms and targeting breathing efficiency and self-efficacy in COPD. Participants are randomized to CALM Breathing or a Usual Care control group.
Primary outcomes include feasibility and acceptability metrics of recruitment efficiency, participant retention, intervention adherence and fidelity, PR facilitation, patient satisfaction, and favorable themes from interviews. Secondary outcomes include breathing biomarkers, symptoms, health-related quality of life, six-minute walk distance, lung function, mood, physical activity, and PR utilization and engagement.
By disrupting the cycle of dyspnea and anxiety, and providing a needed bridge to PR, CALM Breathing may address a substantive gap in healthcare and optimize treatment for patients with COPD.
尽管呼吸困难是慢性阻塞性肺疾病（COPD）的主要症状，但其治疗效果并不理想。在慢性阻塞性肺疾病和急性焦虑症中，呼吸模式都会失调，导致二氧化碳异常、呼吸困难以及呼吸挑战后的恢复效率低下。虽然肺康复（PR）可改善呼吸困难，但只有1-2%的患者接受该治疗。使用肺康复的焦虑症患者预后更差。
我们展示了一项随机对照试验的方案，该试验旨在确定一种新的为期四周的身心干预措施的可行性和可接受性，我们将其称为“二氧化碳描记辅助学习、监测（CALM）呼吸法”，作为肺康复的辅助手段。符合条件的参与者按1:1的比例随机分配到CALM呼吸法项目组或常规护理组。CALM呼吸法包括10项核心的慢呼吸练习，结合实时生物反馈（潮气末二氧化碳、呼吸频率和气流）以及动机性访谈。CALM呼吸法促进自主呼吸，将二氧化碳变化与呼吸困难和焦虑症状联系起来，并针对慢性阻塞性肺疾病中的呼吸效率和自我效能。参与者被随机分配到CALM呼吸法组或常规护理对照组。
主要结果包括招募效率、参与者留存率、干预依从性和保真度、肺康复促进、患者满意度以及访谈中出现的积极主题等可行性和可接受性指标。次要结果包括呼吸生物标志物、症状、健康相关生活质量、六分钟步行距离、肺功能、情绪、身体活动以及肺康复的利用率和参与度。
通过打破呼吸困难和焦虑的循环，并为肺康复提供必要的桥梁，CALM呼吸法可能填补医疗保健中的一个重大空白，并优化慢性阻塞性肺疾病患者的治疗。
