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Mindful Breathing Awareness Through Pursed-Lip Breathing Training

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ClinicalTrials.gov Identifier: NCT03198780
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Minnesota HealthSolutions

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Breathing Awareness Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: pilot study
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: 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.

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




Primary Outcome Measures :
  1. Participant assessment of device feasibility [ Time Frame: up to 1 week ]
    Participants in both arms will complete a subjective questionnaire to elicit information about their experience and opinions about the intervention


Secondary Outcome Measures :
  1. Device Use Assessed by Pulse Oximetry Data [ Time Frame: up to 1 week ]
    The system will track data on each patient's breathing pattern to assess whether they are following the program



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198780


Contacts
Contact: Sara J Seifert, MPH 6128036998 sara.j.seifert@gmail.com

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Roberto Benzo, MD         
Sponsors and Collaborators
Minnesota HealthSolutions
Mayo Clinic
Investigators
Principal Investigator: Kevin Kramer, Ph.D Minnesota HealthSolutions

Responsible Party: Minnesota HealthSolutions
ClinicalTrials.gov Identifier: NCT03198780     History of Changes
Other Study ID Numbers: Mindful Breathing Intervention
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes