COPDCALMNCT04786184

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

A study testing CALM Breathing and Traditional outpatient PR in people with COPD, run by Columbia University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COPD
What is being tested?: CALM Breathing and Traditional outpatient PR
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 2 sitesUnited States
Study dates: 1 Oct 2021to 30 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 15Show fewer

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.

Who cannot join

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

Show all 16Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

New York University Grossman School of Medicine
New York, New York, 10016
Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

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.

Read the 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).

Conditions: COPD
Being tested: CALM Breathing, Traditional outpatient PR
Keywords: Breathing, Anxiety
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CALM BreathingBehavioural
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 PRBehavioural
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.

Study groups in NCT04786184
Study group	Role	What they receive
CALM Breathing	Experimental	Not described Receives: Behavioral: CALM Breathing
Wait-List Control	Active comparator	Not described Receives: Behavioral: Traditional outpatient PR

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Attendance Rate of CALM Breathing Treatment Sessions
Attendance rate will be measured from the total number of sessions completed out of the 8 total.
Measured: 4 weeks
Drop-Out Rate
The drop-out rate will be calculated from the total number of participants who drop-out from receiving the CALM Breathing therapy.
Measured: 3 months
CALM Breathing Satisfaction Rating
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).
Measured: 4 weeks

Secondary outcomes (14)

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.
Measured: Baseline, 4 weeks, 3 months
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 converted into T-scores with a mean score of 50 and a standard deviation of ±10. The full range of T-scores is 0 to 100 for DMQ-CAT Self-Efficacy, DMQ-CAT Intensity and DMQ-CAT Anxiety scales. The DMQ-CAT software automatically scores these scales. Higher scores indicate better outcomes.
Measured: 4 weeks
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 converted into T-scores with a mean score of 50 and a standard deviation of ±10. The full range of T-scores is 0 to 100 for DMQ-CAT Self-Efficacy, DMQ-CAT Intensity and DMQ-CAT Anxiety scales. The DQM-CAT software automatically scores these scales. Higher scores indicate better outcomes.
Measured: 3 months
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 for Borg-Dyspnea and Borg-Fatigue. Higher scores indicate worse outcomes (i.e. more exertion).
Measured: 4 weeks
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 for Borg-Dyspnea and Borg-Fatigue. Higher scores indicate worse outcomes (i.e. more exertion).
Measured: 3 months
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).
Measured: 3 months
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.
Measured: Baseline, 4 weeks, 3 months
6 Mile Walking Distance Score (6MWT)
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.
Measured: Baseline, 4 weeks, 3 months
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.
Measured: 3 months
Change in COPD Assessment Test (CAT) Score
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. The overall score will range from 0 to 40. The score is a composite score.
Measured: 4 weeks, 3 months
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. This applies to PROMIS Social, PROMIS Fatigue, PROMIS Physical, and PROMIS Sleep Disturbance.
Measured: 4 weeks
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. This applies to PROMIS Social, PROMIS Fatigue, PROMIS Physical, and PROMIS Sleep Disturbance.
Measured: 3 months
End-tidal CO2
This measures the partial pressure of CO2 at the end of an exhaled breath.
Measured: Baseline, 4 weeks, 3 months
Patient Activation Measure (PAM) Score
Pulmonary Rehabilitation Engagement will be measured using the Patient Activation Measure (PAM), which is a 10 or 13 item questionnaire that measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes. A higher score indicates a better outcome.
Measured: Baseline, 4 weeks, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202130 Nov 2023

First posted8 Mar 2021
Study start1 Oct 2021
Primary completion14 Jul 2023
Study completion30 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04786184
Sponsor's protocol ID: AAAT8556
Other IDs: 20-00751, R34AT010673
Acronym: CALM
Status last verified: Jun 2024
First submitted: 4 Mar 2021
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with Columbia University. Requests may be directed to the Principal Investigator (PI). The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

Norweg A, Oh C, DiMango A, Hofferber B, Spinner M, Stavrolakes K, Pavol M, Lindenauer P, Murphy CG, Simon NM. Mind the Breath: Feasibility of Capnography-Assisted Learned Monitored (CALM) Breathing for Dyspnea Treatment. J Cardiopulm Rehabil Prev. 2025 Mar 1;45(2):118-131. doi: 10.1097/HCR.0000000000000939. Epub 2025 Feb 13.
PubMed 39976559

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
ClinicalTrials.gov ID: NCT04786184
Acronym / sponsor ID: CALM / AAAT8556
Conditions: COPD
Keywords: Breathing, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 1 Oct 2021 (actual)
Primary completion: 14 Jul 2023 (actual)
Study completion: 30 Nov 2023 (actual)
First posted: 8 Mar 2021 (actual)
Results: Posted 3 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
CALM Breathing	Experimental	Behavioral: CALM Breathing
Wait-List Control	Active comparator	Behavioral: Traditional outpatient PR

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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?")]

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CALM BreathingCALM 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.	Behavioural	CALM Breathing
Traditional outpatient PRAfter 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.	Behavioural	Wait-List Control

Primary outcome

Mean Attendance Rate of CALM Breathing Treatment Sessions
Time frame: 4 weeks
Attendance rate will be measured from the total number of sessions completed out of the 8 total.
Drop-Out Rate
Time frame: 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
Time frame: 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).

14 secondary outcomes

Chronic Respiratory Disease Questionnaire (CRQ) Score
Time frame: Baseline, 4 weeks, 3 months
Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score
Time frame: 4 weeks
Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score
Time frame: 3 months
Modified Borg Scale Score
Time frame: 4 weeks
Modified Borg Scale Score
Time frame: 3 months
Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: 3 months
Perceived Stress Scale Score (PSS)
Time frame: Baseline, 4 weeks, 3 months
6 Mile Walking Distance Score (6MWT)
Time frame: Baseline, 4 weeks, 3 months
Physical Activity Scale for the Elderly (PASE)
Time frame: 3 months
Change in COPD Assessment Test (CAT) Score
Time frame: 4 weeks, 3 months
Patient-Reported Outcomes Measurement Information System (PROMIS-24).
Time frame: 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-24).
Time frame: 3 months
End-tidal CO2
Time frame: Baseline, 4 weeks, 3 months
Patient Activation Measure (PAM) Score
Time frame: Baseline, 4 weeks, 3 months

Results and safety

Results posted to the registry on 3 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CALM Breathing	20	9
Wait-List Control	22	19

Primary outcome: Mean Attendance Rate of CALM Breathing Treatment Sessions

Time frame: 4 weeks. Mean (Full Range). Unit: percentage of completed sessions

Measure	CALM Breathing n = 19
Value	84.2 (0 to 100)

Population analysed: This outcome measure is only measuring attendance for individuals who received the CALM breathing intervention.

Primary outcome: Drop-Out Rate

Time frame: 3 months. Count of participants. Unit: Participants

Measure	CALM Breathing n = 19
Value	1

Population analysed: This outcome measure is only looking to measure the drop-out rate for the CALM Breathing arm.

Primary outcome: CALM Breathing Satisfaction Rating

Time frame: 4 weeks. Mean (Full Range). Unit: score on a scale

Measure	CALM Breathing n = 17
Value	2 (0 to 4)

Population analysed: Only data from the 17 participants who completed the satisfaction questionnaire from the CALM Breathing arm was collected and analyzed.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE data was collected over 3 months from baseline or until the participants completed/withdrew from the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	5 of 42 (11.9%)	11 of 42 (26.2%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39976559Norweg A, Oh C, DiMango A, Hofferber B, Spinner M, Stavrolakes K, Pavol M, Lindenauer P, Murphy CG, Simon NM. Mind the Breath: Feasibility of Capnography-Assisted Learned Monitored (CALM) Breathing for Dyspnea Treatment. J Cardiopulm Rehabil Prev. 2025 Mar 1;45(2):118-131. doi: 10.1097/HCR.0000000000000939. Epub 2025 Feb 13.
Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with Columbia University. Requests may be directed to the Principal Investigator (PI). The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Related trials for COPD

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
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RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Norweg, PhD, OTR principal investigator

Columbia University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CALM Breathing and Traditional outpatient PR in people with COPD, run by Columbia University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Attendance Rate of CALM Breathing Treatment Sessions (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04786184, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.