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

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: Recruiting

Administrative data

• NCT number: NCT05349123
• Other study ID #: Mindful Breathing Awareness
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: March 2024
• Source: Minnesota HealthSolutions
• Contact: Sara J Seifert, MPH
• Phone: 16128036998
• Email: sara[@]minnhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Mindful Breathing Laboratory under the direction of Dr. Benzo will complete a randomized controlled trial to evaluate the mindful breathing module. This rigorous study will evaluate home-based PR system compared to the home-based PR system plus mindful breathing module for its effects on breathlessness and emotions. The investigators hypothesize that the intervention will decrease breathlessness while increasing emotional perception, emotional intelligence, and mindfulness.

Description:

A total of 50 adults diagnosed with COPD will be enrolled in this study. Half of the subjects will be randomized to receive home-based pulmonary rehabilitation with the mindful breathing module (intervention group) and half will receive home-based pulmonary rehabilitation (control group). Each subject will be consented and trained and then participate in either the intervention or control group. Both groups entail one week of baseline and twelve weeks of home-based pulmonary rehabilitation (health coaching plus activity monitoring). The intervention group will also receive the mindful breathing module during the twelve weeks of home-based pulmonary rehabilitation. The Chronic Respiratory Disease Questionnaire (CRQ) will be administered at baseline, week 12 (after the intervention) and week 24 as the investigators will follow the patients for 3 months after the intervention to document the sustainability of the effects (behavior change).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients must be =40 years old
• Patients must have a diagnosis COPD documented by pulmonary function testing; breathlessness of score 2 or higher by the Medical Research Council Score
• Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking

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; or 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)
• Patients with an inability to do mild exercise (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of <20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindful Breathing
Subject will be expected to do 12 weeks of home-based rehabilitation, 6 days a week in their home. The proposed project explores the addition of a mindful breathing module, which involves daily guided breathing practice with feedback to encourage mindful breathing.
• Home-Based Pulmonary Rehabilitation
Subject will be asked to complete exercise guided by a video six days a week and to complete mindful walking six days per week. They will receive weekly health coaching calls.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	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	Breathlessness	Breathlessness as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including dyspnea (breathlessness). Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.	12 weeks
Primary	Emotion	Emotion as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including emotion. Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.	12 weeks
Secondary	Physical Activity	Physical activity as measured by the ActiGraph, primarily daily steps	12 weeks