Mindful Breathing Awareness Through Pursed-Lip Breathing Training

NCT ID: NCT03198780

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Breathing Awareness

In the clinic, once patients are proficient with the proposed tool, they will (1) independently don the pulse oximeter, (2) use the prototype to perform the mindful breathing intervention. The whole session will last no longer than 60 minutes with 30 minutes for the consent and demonstrations, two minutes to don the study devices, 15 minutes to practice mindful breathing, and two minutes to doff the study devices. The mindful breathing portion will be divided into three sessions. Each session will last three minutes and display a different presentation of Heart Rate Coherence biofeedback.

At home, after completing the in-clinic study, five patients will take the mindful breathing tool home for a week to practice pursed-lip breathing at least five times. They will don the study devices, perform the intervention, and doff study devices.

Group Type: EXPERIMENTAL

Breathing Awareness

Intervention Type: OTHER

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

Interventions

Breathing Awareness

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Minnesota HealthSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Kramer, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Minnesota HealthSolutions

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

Mindful Breathing Intervention

Identifier Type: -

Identifier Source: org_study_id