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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03814980
Recruitment Status : Enrolling by invitation
First Posted : January 24, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date June 5, 2019
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
Test the feasibility of a mindful breathing application for COPD patients [ Time Frame: About 1 week ]
Mindful Breathing Application on a computer tablet for COPD patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03814980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Official Title  ICMJE A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Emphysema
Intervention  ICMJE
  • Behavioral: mindful breathing application
    Participants will use a mindful breathing application on a computer tablet.
  • Device: application on a computer tablet
    a computer tablet
Study Arms  ICMJE Experimental: Pilot Study
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.
Interventions:
  • Behavioral: mindful breathing application
  • Device: application on a computer tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Patients eligible for Pulmonary Rehabilitation will be recruited for this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03814980
Other Study ID Numbers  ICMJE 17-004445
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roberto P. Benzo, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto P Benzo Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP