Clinical trial NCT04786184: Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
Official title: Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Breathing
Anxiety
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-03-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective RCT: In Phase I, participants will be randomized 1:1 to one of two groups: CALM Breathing (N = 25) and Wait-List control (N = 25). In Phase II, both groups will be offered Columbia University's 10-week PR program (care as usual). Access to timely initiation of PR will be facilitated. We will use a hybrid design to evaluate feasibility and acceptability.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Attendance Rate of CALM Breathing Treatment Sessions
timeFrame: 4 weeks
measure: Drop-Out Rate
timeFrame: 3 months
measure: CALM Breathing Satisfaction Rating
timeFrame: 4 weeks
Secondary outcomes:
measure: Chronic Respiratory Disease Questionnaire (CRQ) Score
timeFrame: Baseline, 4 weeks, 3 months
measure: Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score
timeFrame: 4 weeks
measure: Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score
timeFrame: 3 months
measure: Modified Borg Scale Score
timeFrame: 4 weeks
measure: Modified Borg Scale Score
timeFrame: 3 months
measure: Generalized Anxiety Disorder-7 (GAD-7) Score
timeFrame: 3 months
measure: Perceived Stress Scale Score (PSS)
timeFrame: Baseline, 4 weeks, 3 months
measure: 6 Mile Walking Distance Score (6MWT)
timeFrame: Baseline, 4 weeks, 3 months
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 3 months
measure: Change in COPD Assessment Test (CAT) Score
timeFrame: 4 weeks, 3 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-24).
timeFrame: 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-24).
timeFrame: 3 months
measure: End-tidal CO2
timeFrame: Baseline, 4 weeks, 3 months
measure: Patient Activation Measure (PAM) Score
timeFrame: Baseline, 4 weeks, 3 months
Other outcomes:
measure: Self-Evaluation of Breathing Questionnaire (SEBQ) Score
timeFrame: Baseline, 4 weeks, 3 months
Locations:
city: New York
country: United States
facility: New York University Grossman School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Anna Norweg, PhD, OTR
role: PRINCIPAL_INVESTIGATOR
References: