- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786184
Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD (CALM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Norweg, PhD, OTR
- Phone Number: 212-305-1651
- Email: amn2212@cumc.columbia.edu
Study Contact Backup
- Name: Brittany Hofferber
- Email: bth2119@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University Grossman School of Medicine
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Active Comparator: Wait-List Control
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Number of Participants with High Attendance Rate of CALM Breathing Treatment Sessions
Time Frame: 3 months
|
High attendance rate is defined as greater than or equal to 70% (where 100% = all 8 sessions attended).
|
3 months
|
Acceptability Aim #2 CALM Breathing Attendance
Time Frame: 3 months
|
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
|
Acceptability Aim #2 Drop-Out Rate
Time Frame: 3 months
|
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
|
Acceptability Aim #2 CALM Breathing Satisfaction
Time Frame: 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic Respiratory Disease Questionnaire (CRQ) Score
Time Frame: 3 months
|
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
|
Dyspnea management Questionnaire Computer Adaptive test (DMQ-CAT) Score
Time Frame: 3 months
|
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
|
Modified Borg Scale Score
Time Frame: 3 months
|
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
|
Generalized Anxiety Disorder-7 (GAD-7) Score
Time Frame: 3 months
|
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
|
Perceived Stress Scale Score (PSS)
Time Frame: 3 months
|
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
|
6 mile Walking Distance Score (6MinWT)
Time Frame: 3 months
|
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
|
Physical Activity Scale for the Elderly (PASE)
Time Frame: 3 months
|
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
|
COPD Assessment Test (CAT)
Time Frame: 3 months
|
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
|
Patient-Reported Outcomes Measurement Information System (PROMIS-24).
Time Frame: 3 months
|
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
|
End-tidal CO2
Time Frame: 3 months
|
This measures the partial pressure of CO2 at the end of an exhaled breath.
|
3 months
|
Respiratory Rate (RR)
Time Frame: 3 months
|
The RR will be measured as total number of breaths per minute.
|
3 months
|
Predicted Forced Expiratory Volume (FEV1) Percentage
Time Frame: 3 months
|
Percent of predicted forced expiratory volume (FEV) in 1 second.
|
3 months
|
Forced vital capacity (FVC)
Time Frame: 3 months
|
FVC measures the total amount of air exhaled during the FEV test.
|
3 months
|
Ratio of FEV1/FVC
Time Frame: 3 months
|
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
|
Pulmonary Rehabilitation Engagement
Time Frame: 3 months
|
Uptake; treatment initiation; attrition; and patient activation using the Patient Activation Measure.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Norweg, PhD, OTR, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT8556
- 20-00751 (Other Identifier: NYU Langone Health)
- R34AT010673 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD
-
University Medical Center GroningenCompleted
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Not yet recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
University Hospital, BrestRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Baylor Research InstituteNot yet recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
Clinical Trials on CALM Breathing
-
Central Arkansas Veterans Healthcare SystemCompleted
-
University of Colorado, DenverCompleted
-
Florida International UniversityAndrew Kukes Foundation for Social AnxietyCompleted
-
Arizona State UniversityCalm.com, Inc.Completed
-
Arizona State UniversityCompleted
-
Harvard UniversityJohn WeiszRecruitingDepression | Anxiety | Trauma | Child BehaviorUnited States
-
Radicle ScienceCompletedStress | AnxietyUnited States
-
University of California, BerkeleyTerminatedSuicidal Ideation | Impulsivity | Deliberate Self-harmUnited States
-
Virginia Commonwealth UniversityAmerican Psychological FoundationTerminatedBrain Cancer | Caregivers | Neuro-OncologyUnited States
-
Università degli Studi di FerraraUniversity Health Network, Toronto; Princess Margaret Hospital, CanadaUnknownDepression | Quality of Life | AnxietyItaly