Back to resultsMindful Breathing Awareness Through Pursed-Lip Breathing Training
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing Awareness
Sponsored by
About this trial
This is an interventional device feasibility trial for Chronic Obstructive Pulmonary Disease
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).
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breathing Awareness
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Device Use Assessed by Pulse Oximetry Data
The system will track data on each patient's breathing pattern to assess whether they are following the program
Full Information
NCT ID
NCT03198780
First Posted
June 21, 2017
Last Updated
October 28, 2019
Sponsor
Minnesota HealthSolutions
Collaborators
Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03198780
Brief Title
Mindful Breathing Awareness Through Pursed-Lip Breathing Training
Official Title
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnesota HealthSolutions
Collaborators
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breathing Awareness
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Breathing Awareness
Intervention Description
Participants will use a pulse-oximeter and biofeedback app to guide them through pursed-lip breathing training.
Primary Outcome Measure Information:
Title
Participant assessment of device feasibility
Description
Participants in both arms will complete a subjective questionnaire to elicit information about their experience and opinions about the intervention
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Device Use Assessed by Pulse Oximetry Data
Description
The system will track data on each patient's breathing pattern to assess whether they are following the program
Time Frame
up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Kramer, Ph.D
Organizational Affiliation
Minnesota HealthSolutions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindful Breathing Awareness Through Pursed-Lip Breathing Training
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