Back to resultsA Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Primary Purpose
COPD, Emphysema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindful breathing application
application on a computer tablet
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Patients eligible for Pulmonary Rehabilitation will be recruited for this study.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot Study
Arm Description
Participants will be shown how to use a mindful breathing software application. The software will be used for 1 week. At the end of the week, participants will evaluate the software.
Outcomes
Primary Outcome Measures
Test the feasibility of a mindful breathing application for COPD patients
Mindful Breathing Application on a computer tablet for COPD patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03814980
Brief Title
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
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
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, a system will be developed to guide patients with chronic obstructive pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third leading cause of death in the United States and no cure exists. Shortness of breath is the most common disabling symptom. Pursed lips breathing is a type of breathing practice that has demonstrated effectiveness for patients with COPD. It requires practice to maintain and there is currently no home system to provide the needed feedback and support to maintain PLB. Additionally, syncing breathing and heart rate variation offers patients additional benefits. The proposed project explores the use of biofeedback to guide COPD patients in a breathing practice and to provide data for health coaching to monitor and support the practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot Study
Arm Type
Experimental
Arm Description
Participants will be shown how to use a mindful breathing software application. The software will be used for 1 week. At the end of the week, participants will evaluate the software.
Intervention Type
Behavioral
Intervention Name(s)
mindful breathing application
Intervention Description
Participants will use a mindful breathing application on a computer tablet.
Intervention Type
Device
Intervention Name(s)
application on a computer tablet
Intervention Description
a computer tablet
Primary Outcome Measure Information:
Title
Test the feasibility of a mindful breathing application for COPD patients
Description
Mindful Breathing Application on a computer tablet for COPD patients
Time Frame
About 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients eligible for Pulmonary Rehabilitation will be recruited for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
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