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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

基本信息

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
项目类别：
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

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.

项目总结/文摘