Mindful Breathing Awareness Through Pursed-Lip Breathing Training

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198780
• Other study ID #: Mindful Breathing Intervention
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: October 2019
• Source: Minnesota HealthSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minnesota HealthSolutions	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	up to 1 week