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Mindful Breathing Awareness Through Pursed-Lip Breathing Training

A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03198780
Enrollment
10
Registered
2017-06-26
Start date
2018-10-01
Completion date
2019-07-31
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

To establish the feasibility of a tool that monitors and motivates people with COPD to complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at home.

Detailed description

For this pilot study patients who meet the conventional criteria for pulmonary rehabilitation at their clinical appointments will be recruited and scheduled to return for the study. After completing the informed consent, patients will be taught how to don and doff the pulse oximeter, the source of the heart rate and oxygen signals. Patients will participate in a demonstration on how to perform the intervention. Recruitment will continue until five patients have completed the pilot in a clinic setting. If necessary, the prototype will be modified and testing resumed. Once the prototype system has met the criteria for success in the clinic, five of patients will be asked to use the prototype at the clinic and to take it home for a week and perform the intervention at least five times.

Interventions

Participants will use a pulse-oximeter and biofeedback app to guide them through pursed-lip breathing training.

Sponsors

Mayo Clinic
CollaboratorOTHER
Minnesota HealthSolutions
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

pilot study

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients must be ≥40 years old * have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing * have clinically significant breathlessness (breathless when walking on the level or walking a mild hill) * be a current or previous smoker with at least 10 pack-years of cigarette smoking * be hospitalized for an exacerbation of COPD.

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, 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).

Design outcomes

Primary

MeasureTime frameDescription
Participant assessment of device feasibilityup to 1 weekParticipants in both arms will complete a subjective questionnaire to elicit information about their experience and opinions about the intervention

Secondary

MeasureTime frameDescription
Device Use Assessed by Pulse Oximetry Dataup to 1 weekThe system will track data on each patient's breathing pattern to assess whether they are following the program

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026