Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mean Attendance Rate of CALM Breathing Treatment Sessions
研究概览
简要总结
This pilot study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from the Capnography-Assisted Respiratory Therapy (CART) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.
详细描述
The purpose of this study is to evaluate an experimental breathing therapy for adults with chronic obstructive pulmonary disease (COPD) called Capnography-Assisted Learned, Monitored (CALM) Breathing. CALM Breathing is an experimental therapy that uses exercises combined with breathing feedback. CALM Breathing promotes self-regulated breathing to relieve symptoms. In sessions, biofeedback of breathing is predominately provided by two devices that are cleared by the Food and Drug Administration (FDA) to measure carbon dioxide at the end of a breath and breathing rate. A capnograph uses tubing at the nose to evaluate levels of carbon dioxide and breathing rate from exhaled air and to display breathing patterns. A pulse oximeter for home use also evaluates breathing rate at the fingertip with a sensor that detects blood flow changes. The investigators are studying CALM Breathing to see if it can relieve shortness of breath and other symptoms; reduce stress; and improve quality of life and exercise tolerance in adults with COPD. The investigators are planning to recruit up to approximately 65 subjects with COPD at Columbia University Irving Medical Center. Participants will be assigned by chance into one of two treatment groups: 1) CALM Breathing or Usual Care (Waitlist). Participants will have an equal chance of being assigned to either group. CALM Breathing is a 4-week therapy program that uses breathing exercises with biofeedback to reduce shortness of breath and other symptoms related to COPD. Biofeedback uses sensors to give information about breathing pattern and airflow to help participants better self-regulate their breathing. Participants assigned by chance to CALM Breathing, will participate in eight breathing therapy sessions, provided twice per week; each session will each take approximately 1-hour. All participants will receive 16-20 standard care pulmonary rehabilitation sessions beginning at approximately week 6-10. Participants will complete three study evaluation visits (at baseline, ~6 weeks, and at a 3-month follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be adult males or females
- •have a diagnosis of COPD as defined by FEV1/FVC of < 0.70 on spirometry testing or as shown on a chest computed tomography (CT)
- •receive standard care of pharmacotherapy with bronchodilators (e.g. long-acting beta-agonists, LABAs, or long-acting muscarinic antagonists, or LAMAs) as prescribed by their physician
- •are in stable medical condition as determined by pulmonary rehabilitation physician (i.e., not in need of acute higher level of care such as hospitalization)
- •have dyspnea [as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: "Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or "yes" response of binary presence of dyspnea-related avoidance of activities: "Have you avoided any activities due to shortness of breath?")]
- •have elevated dyspnea-related anxiety symptoms:
- •DMQ-CAT dyspnea anxiety score ≤50; or
- •DMQ-CAT activity avoidance ≤50;
- •VAS dyspnea anxiety scale score of ≥20, administered with 6-minute walk test;
- •ASI-16: item #10, "It scares me when I become short of breath (at least "some");
- •require ≤ 24 hours per day of supplemental oxygen
- •Mini-Mental State Examination score ≥24
- •speak, read, and write English
- •are stably medicated for at least 4 weeks prior to study entry with long-acting anti-anxiety medication (e.g., selective serotonin reuptake inhibitors, SSRIs, and serotonin norepinephrine reuptake inhibitors, SNRIs), benzodiazepines, or cannabis if prescribed, with no plans to change psychotropic medication dose
- •have not received any pulmonary rehabilitation training in the past 12 months.
排除标准
- •are not eligible for pulmonary rehabilitation
- •are actively being treated for cancer
- •have morbid obesity (Body Mass Index (BMI) > 40)
- •have hypercapnia of ETCO2 > 50 mmHg at rest
- •have a musculoskeletal disorder severe enough to interfere with walking or ability to exercise or have neuromuscular disease
- •have had a seizure in the past 3 months
- •reside in an acute hospital, sub-acute care, assisted living, or nursing home
- •are active smokers
- •are pregnant
- •have any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening, which in the opinion of the investigator may put the patient at risk or interfere with study assessments
- •have low literacy as indicated by scores of 4 or 5 ("often" and "always") on the Single Item Literacy Screener (SILS) that asks, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?"
- •have a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist
- •have alcohol or substance abuse or dependence within the past 6 months as evaluated by study psychologist
- •have serious suicidal risk (suicidal ideation or suicidal behaviors within the past year) as defined by a score of >1 on psychologist interview-administered Clinician Suicide Assessment Checklist, which is a Modified Columbia-Suicide Severity Rating Scale-CSSRS
- •Take prescribed opioids ≥50 MME (morphine mg equivalents) per day. A dosage threshold of ≥50 MME significantly increases the risk of fatal respiratory depression and necessitates additional precautions. Participants' opioid medication dose will be confirmed by their prescribing physician (e.g., their primary care or pain management doctor).
- •Actively take both prescribed opioids and benzodiazepines. Combining benzodiazepines and opioids significantly increases the risk of respiratory failure in patients with chronic obstructive pulmonary disease.
结局指标
主要结局
Mean Attendance Rate of CALM Breathing Treatment Sessions
时间窗: 4 weeks
Attendance rate will be measured from the total number of sessions completed out of the 8 total.
Drop-Out Rate
时间窗: 3 months
The drop-out rate will be calculated from the total number of participants who drop-out from receiving the CALM Breathing therapy.
CALM Breathing Satisfaction Rating
时间窗: 4 weeks
The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing satisfaction ratings. Participants were asked item 8 of FACIT ("how do rate this treatment overall?"), which was rated from 0 to 4 (0 = "poor" and 4 = "excellent") in which higher scores indicate more satisfaction (better outcome).
次要结局
- Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score(3 months)
- Generalized Anxiety Disorder-7 (GAD-7) Score(3 months)
- Physical Activity Scale for the Elderly (PASE)(3 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS-24).(3 months)
- End-tidal CO2(Baseline, 4 weeks, 3 months)
- Patient Activation Measure (PAM) Score(Baseline, 4 weeks, 3 months)
- Modified Borg Scale Score(3 months)
- Perceived Stress Scale Score (PSS)(Baseline, 4 weeks, 3 months)
- 6 Mile Walking Distance Score (6MWT)(Baseline, 4 weeks, 3 months)
- Chronic Respiratory Disease Questionnaire (CRQ) Score(Baseline, 4 weeks, 3 months)
- Change in COPD Assessment Test (CAT) Score(4 weeks, 3 months)