A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Minnesota HealthSolutions

A home-based intervention to promote mindful breathing awareness 
through pursed-lip breathing training for COPD patients 
 
NCT05349123 
 
June 8, 2021 
 
 

Site Principal Investigator: Roberto Benzo, MD 
Protocol version number and date: June 8, 2021, Version 3 
 
Hypothesis: 
We hypothesize that providing COPD patients with a mindful breathing module that is easy-to-
use, prompts them to complete daily mindful breathing practice, and provides feedback will 
improve their breathing mechanics, emotional awareness, increase the time that they spend in 
heart rate coherence, and improve their quality of life. 
 
Aims, purpose, or objectives: 
The primary outcomes of the study are changes in breathlessness and emotions. Changes from 
baseline to three months on the two primary outcomes will be compared between the study 
arms using two-sample, two-sided t-tests with 5% type I error rates. Means, SDs, medians, 
ranges, and frequency distributions will be reported and plotted over time by study arm. Linear 
models will be used to assess the impact of treatment arm on three-month outcomes after 
adjusting for the corresponding baseline measure and other variables related to the outcome 
(age, degree of breathlessness at baseline using the mMRC dyspnea, and FEV1). 
 
Methods:  
This project will involve two Phases: phase one in which mindful breathing by itself without any 
other device will be tested to make sure that it is acceptable to patients and makes a difference 
comparing to the usual protocol in use right now. Phase two will include a particular device that 
will guide the mindful breathing practice that we think will be more intuitive to practice and guide 
the mindful breathing and that device will be tested once we know that the acceptance to the 
mindful breathing practice, from phase one, is appropriate.  
 
Phase 1: A total of 70 adults diagnosed with COPD will be enrolled in the study. Half of the 
participants will be randomized to receive the home-based PR with the Pursed Lipped Breathing 
Application (intervention) and half will receive the home-based PR (control). Randomization will 
take place in a REDCap database and will be in equal proportion.  
 
Phase 2: A total of 70 adults diagnosed with COPD will be enrolled in the study. Half of the 
participants will be randomized to receive the home-based PR with the mindful breathing 
module which consists of the Pursed Lipped Breathing Application and the Spire Health Tags 
(intervention) and half will receive the home-based PR (control). Randomization will be take 
place in a REDCap database and will be in equal proportion.  
 
Both groups entail one week of baseline where the participants wear an ActiGraph activity 
tracker and answer questionnaires. Baseline is followed by 12 weeks of home-based PR plus 
health coaching. The Intervention group also has the mindful breathing module loaded on the 
Android tablet. Both groups will also complete questionnaires and wear an ActiGraph activity 
monitor at 3 and 6 months.  
 
Questionnaires:  
Quality of Life will be assessed three times (baseline, 3 and 6 months) by the Medical Research 
Council (mMCR) questionnaire, the Chronic Respiratory Disease Questionnaire (CRQ), the 
Self-Management Ability Scale (SMAS30) and the Mindful Attention and Awareness Scale 
(MAAS). The questionnaires take about 20 minutes to complete.  
At baseline additional health data will be collected from the medical record (chart review) to 
complete the Charlson comorbidity index, including lung function, demographics, living condition 
(living alone or not), GOLD stage, and comorbidities.  

 
ActiGraph:  
Physical activity will be measured three times (baseline, 3 and 6 months) by the ActiGraph 
activity monitor. The ActiGraph activity monitor has tri-axial accelerometers and will be wrist 
worn for seven days. Important measures to be analyzed are daily number of steps, activity 
counts, minutes per day spent in daily physical activities of at least moderate intensity, and 
sedentary time (<2 metabolic equivalents).  
 
The questionnaires and Acti Graphs will be mailed to the participant with pre-paid shipping 
materials to send back.  
 
Health Coaching:  
All participants will receive a weekly coaching call to discuss their rehabilitation and health 
process. The calls are structured using motivational interviewing. The coach will review with the 
patient the data from the health coach system. Collaboratively, goals for rehabilitation for the 
following week will be set, based on information gathered and the patients’ personal 
preferences. Each call lasts about 20 minutes. All calls will be taped to ensure compliance with 
the protocol. 
 
Target accrual: 140  
Subject population (children, adults, groups): Adults 40 years of age or older  
Inclusion Criteria:  
• 
Clinical diagnosis of COPD  
• 
At least 10 pack years of smoking  
 
Exclusion Criteria:  
• 
Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed)  
• 
Unable to follow commands (cognitive impairment)  
• 
Have a high likelihood of being lost to follow-up (active alcohol or drug abuse)  
• 
Live in an area that does not have cellular service (Verizon)  
 
Potential participants will have the option of meeting a study coordinator in person (if they are 
on campus for a clinical appointment), meeting via Video Anywhere through Epic, or meeting 
over the phone. If the patient desires, their consent can be digitally obtained and documented 
through PTRAX. The patient also has the option of receiving the consent via mail and mailing 
back the consent in a provided postage paid envelope. Documentation of informed 
consent/HIPAA authorization will involve the use of the Research Participant Tracking (PTrax) 
Digital Signature Capture technology for research informed consent/HIPAA authorization forms.  
This is an institutionally approved process for documenting consent/HIPAA authorization only 
while the subject, and/or the subject’s representative, is in the physical presence of the person 
authorized to obtain consent/HIPAA authorization. The study team may print a copy of the 
signed consent form/HIPAA authorization form for the subject or their representative. The 
consent form/HIPAA authorization form will also be available to the subject via the patient portal. 
Note: If the subject or their representative prefers not to use the Digital Signature Capture 
technology, the study team will provide a paper consent form/HIPAA authorization form for 
signature. 
 
 
 
 
 

Statistica Analysis Plan 
 
Sample Size  
We calculated that sixty two participants will provide 80% power to detect 1 point of change in 
the two co primary outcomes (breathlessness and emotion as measured by the CRQ) with an 
alpha of 0.025. A 1 point change represents a clinically meaningful change.95 We expect about 
a 20 percent attrition rate (withdraw, not able to complete the 12 weeks of home-based rehab) 
and will therefore enroll 70 participants in each phase.  
 
Analysis Plan  
The primary outcomes of the study are changes in breathlessness and emotions. Changes from 
baseline to three months on the two primary outcomes will be compared between the study 
arms using two-sample, two-sided t-tests with 5% type I error rates. Means, SDs, medians, 
ranges, and frequency distributions will be reported and plotted over time by study arm. Linear 
models will be used to assess the impact of treatment arm on three-month outcomes after 
adjusting for the corresponding baseline measure and other variables related to the outcome 
(age, degree of breathlessness at baseline using the mMRC dyspnea, and FEV1).  
The Chronic Respiratory Disease Questionnaire (CRQ) is a 20-question inventory assessing the 
areas of dyspnea, fatigue, emotion, and feelings of mastery. The fatigue, emotion, and mastery 
subscales ask patients to rate how often in the last two weeks they have been afflicted with a 
particular feeling or experience on a scale of 1 to 7, with higher ratings indicating less symptom 
impairment. The CRQ has shown to be valid and has high internal consistency reliability. Test-
retest reliability is adequate in all subscales, but is particularly high in the subscales of fatigue 
(r=0.90), emotion (r=0.93), and mastery (r=0.91). The minimal clinically important difference for 
this instrument of 0.5 points is universally recognized. The Domains Dyspnea (breathlessness) 
and Emotions are the two co primary outcomes.  
 
Physical activity will be measured at baseline, 3, and 6 months by the ActiGraph GX6 activity 
monitor, which has been used to assess physical activity in COPD populations. (92) The 
number of daily steps at baseline, 3, and 6 months and across the two groups will be compared. 
Emotional Intelligence will be measured by the Trait Emotional Intelligence questionnaire at 
baseline, 3, and 6 months .(84) Mindfulness will be measured by the Mindful Attention and 
Awareness Scale at baseline, 3, and 6 months.(93) The participants HRC and respiratory rate 
will be tracked for the entire intervention period using the Spire Health Tags. At baseline 
additional health data will be collected from each participant’s medical record to complete the 
Charlson comorbidity index, including lung function, demographics, living condition (living alone 
or not), GOLD stage, and comorbidities.