N/A
N=99
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT05349123 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Breathlessness — 0.68; 0.71; 0.34; 0.83 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindful Breathing (Behavioral); Home-Based Pulmonary Rehabilitation (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Minnesota HealthSolutions
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breathlessness |
0.68; 0.71; 0.34; 0.83 | — |
| PRIMARY Emotion |
0.45; 0.55; 0.35; 0.5 | — |
| SECONDARY Physical Activity |
765.98; 701.5; -181.78; 290.36 | — |
Summary
The Mindful Breathing Laboratory under the direction of Dr. Benzo will complete a randomized controlled trial to evaluate the mindful breathing module. This rigorous study will evaluate home-based PR system compared to the home-based PR system plus mindful breathing module for its effects on breathlessness and emotions. The investigators hypothesize that the intervention will decrease breathlessness while increasing emotional perception, emotional intelligence, and mindfulness.
Eligibility Criteria
Inclusion Criteria
- Patients must be ≥40 years old
- Patients must have a diagnosis COPD documented by pulmonary function testing; breathlessness of score 2 or higher by the Medical Research Council Score
- Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking
Exclusion Criteria
- Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state; or are not living in the healthcare area
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition)
- Patients with an inability to do mild exercise (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of <20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).
Data sourced from ClinicalTrials.gov (NCT05349123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.