Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD

COPD Clinical Trial

— CALM  

Official title:

Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786184
• Other study ID #: AAAT8556
• Secondary ID: 20-00751R34AT010
• Status: Completed
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: July 14, 2023

Study information

• Verified date: December 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Respiratory Aspiration

Intervention

Behavioral:
• CALM Breathing
CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide.
• Traditional outpatient PR
After referral to Columbia's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency: 1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York
United States	New York University Grossman School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Participants with High Attendance Rate of CALM Breathing Treatment Sessions	High attendance rate is defined as greater than or equal to 70% (where 100% = all 8 sessions attended).	3 months
Primary	Acceptability Aim #2 CALM Breathing Attendance	The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and from semi-structured interviews.; Acceptability will be determined in part by whether or not we achieve a =70% CALM Breathing attendance.	3 months
Primary	Acceptability Aim #2 Drop-Out Rate	The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and from semi-structured interviews.; Acceptability will be determined in part by whether or not we achieve a CALM Breathing drop-out rate of =10-15%.	3 months
Primary	Acceptability Aim #2 CALM Breathing Satisfaction	The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and semi-structured interviews.; Acceptability will be determined in part by whether or not we achieve a mean of =2 "good" satisfaction rating for CALM Breathing treatment overall (item 8 of FACIT; (0-4 scale). Higher scores indicate more satisfaction. Single FACIT Treatment Satisfaction items (6 and 8) ask: (1) "Would you recommend this treatment to others with your illness?" (with 0-2 rating scale, 0 = "No", 1 = "Maybe", 2 = "Yes"); and (2) "How do you rate this treatment [CALM Breathing] overall?" (with 0-4 rating scale, 0 = "poor" and 4 = "excellent"). The investigators will also ask, "How do you rate the CALM Breathing home exercises overall?" (and use the same FACIT 0-4 rating scale).	3 months
Secondary	Chronic Respiratory Disease Questionnaire (CRQ) Score	This questionnaire measures the impact of chronic obstructive pulmonary disease (COPD) on a person's life. It consists of 20 items across 4 domains (dyspnea, fatigue, emotional function, and master). Items are on a 7-point Likert scale (1 - 7) and are scored from 1 (most severe) to 7 (no impairment) (better outcome). For this trial, questions 4a- 4e are included which is the dyspnea domain. The 5 scores are summated and divided by the number of items. The range is 1-7. Higher scores indicate better outcomes.	3 months
Secondary	Dyspnea management Questionnaire Computer Adaptive test (DMQ-CAT) Score	The DMQ-CAT is a 71-item questionnaire that measures dyspnea anxiety. Raw scores range from 0 (low) to 6 (high). These raw scores are transformed into item response theory (IRT) calibrations with a mean score of 50 and a standard deviation of ±10. The full range is 0 to 100. The DQM-CAT software automatically scores these scales. Higher scores indicate better outcomes.	3 months
Secondary	Modified Borg Scale Score	The Modified Borg Scale is most commonly used to assess symptoms of breathlessness. On the 11-item scale, a score of 0 indicates "No Exertion" and a score of 10 indicates "Maximal" exertion (10-point scale). The full range is 0-10. Higher scores indicate worse outcomes (i.e. more exertion). An average of the pre-Tx, post-Tx, and 3-month 6-Minute Walk Test Modified Borg Scale Scores could be reported (taken from all participants).	3 months
Secondary	Generalized Anxiety Disorder-7 (GAD-7) Score	The General Anxiety Disorder-7 is a 7-item screening tool and symptom severity measure for the four most common anxiety disorders. This is calculated by assigning scores of 0 ("not at all"), 1 ("several days'), 2 ("more than half the days"), or 3 ("nearly every day"). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate worse outcomes (i.e. greater anxiety).	3 months
Secondary	Perceived Stress Scale Score (PSS)	The PSS is a 10-item classic stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	3 months
Secondary	6 mile Walking Distance Score (6MinWT)	This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	3 months
Secondary	Physical Activity Scale for the Elderly (PASE)	This 12-item questionnaire uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.	3 months
Secondary	COPD Assessment Test (CAT)	The CAT quantifies the impact of COPD symptoms on patients' overall health. Participants assign a score ranging from 0 to 5 for each of the 8 areas. A score of 0 means there is no impairment in that area. A score of 5 means severe impairment. Your overall score will range from 0 to 40. The score is a composite score.	3 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-24).	This is a 10-item tool used to measure patient-reported outcomes (PROs) relevant across common medical conditions. The response options are presented as a 5-point rating scale, with higher scores indicating a healthier patient (better outcome). Scores are standardized to the general population using the "T-Score", with the average T-score for the US population is 50 points, with a SD of 10 points.	3 months
Secondary	End-tidal CO2	This measures the partial pressure of CO2 at the end of an exhaled breath.	3 months
Secondary	Respiratory Rate (RR)	The RR will be measured as total number of breaths per minute.	3 months
Secondary	Predicted Forced Expiratory Volume (FEV1) Percentage	Percent of predicted forced expiratory volume (FEV) in 1 second.	3 months
Secondary	Forced vital capacity (FVC)	FVC measures the total amount of air exhaled during the FEV test.	3 months
Secondary	Ratio of FEV1/FVC	Ratio of FEV1/FVC based on American Thoracic Society (ATS) guidelines and will be calculated from the FEV1 and FVC values. This is used to confirm diagnosis of COPD.	3 months
Secondary	Pulmonary Rehabilitation Engagement	Uptake; treatment initiation; attrition; and patient activation using the Patient Activation Measure.	3 months