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

NCT05349123 | Completed Results

• 1 other identifier: Mindful Breathing Awareness
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, 3 months, 6 months

• 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.

  baseline, 3 months, 6 months

Secondary Outcomes (1)

• Physical Activity

  baseline, 3 months, 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module

Behavioral: Mindful Breathing; Behavioral: Home-Based Pulmonary Rehabilitation

Control

ACTIVE COMPARATOR

Home-based pulmonary rehabilitation that includes health coaching

Behavioral: Home-Based Pulmonary Rehabilitation

Interventions

Mindful Breathing BEHAVIORAL

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.

Intervention

Home-Based Pulmonary Rehabilitation BEHAVIORAL

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.

Also known as: Health Coaching

Control; Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Minnesota HealthSolutions: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roberto P Benzo
• Organization: Mayo Clinic

benzo.roberto@mayo.edu

507-284-0561

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the patients will know if they have the Pursed Lipped Breathing Application and Spire tags, the outcome assessor will be blinded to which arm received the Application and tags.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Half of the subjects will be randomized to receive home-based PR with the mindful breathing module (intervention group) and half will receive home-based PR (control group).

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 27, 2022
• Study Start: January 10, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)