Phase 3
N=99
A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients
COPD
Bottom Line
View on ClinicalTrials.gov: NCT04517500 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score — 0.68; 0.71; 0.34; 0.83 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Home-based pulmonary rehabilitation program (Behavioral); Mindful breathing module (Behavioral); Health coaching (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score |
0.68; 0.71; 0.34; 0.83 | — |
| PRIMARY Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score |
0.45; 0.55; 0.35; 0.5 | — |
| SECONDARY Change in Daily Physical Activity |
765.98; 701.5; -181.78; 290.36 | — |
Summary
The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.
Eligibility Criteria
Inclusion Criteria
- Adults, age ≥ 40 years old.
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease (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).
Data sourced from ClinicalTrials.gov (NCT04517500). 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.