NCT04786184

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• COPD

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-07-14
• Completion: 2023-11-30
• First posted: 2021-03-08
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

2 sites across 1 country: United States