Mindful Breathing Awareness Through Pursed-Lip Breathing Training

NCT03198780 | Completed

• 1 other identifier: Mindful Breathing Intervention
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Participant assessment of device feasibility

  Participants in both arms will complete a subjective questionnaire to elicit information about their experience and opinions about the intervention

  up to 1 week

Secondary Outcomes (1)

• Device Use Assessed by Pulse Oximetry Data

  up to 1 week

Study Arms (1)

Breathing Awareness

EXPERIMENTAL

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.

Other: Breathing Awareness

Interventions

Breathing Awareness OTHER

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

Breathing Awareness

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Minnesota HealthSolutions: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Kramer, Ph.D

  Minnesota HealthSolutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: pilot study

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 26, 2017
• Study Start: October 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)