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

NCT ID: NCT05349123

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2024-05-07

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.

Detailed 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).

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Mindful Breathing

Intervention Type: 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.

Home-Based Pulmonary Rehabilitation

Intervention Type: 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.

Control

Home-based pulmonary rehabilitation that includes health coaching

Group Type: ACTIVE_COMPARATOR

Home-Based Pulmonary Rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Health Coaching

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Minnesota HealthSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Mindful Breathing Awareness

Identifier Type: -

Identifier Source: org_study_id