A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients

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

The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: Home-based pulmonary rehabilitation program; Behavioral: Mindful breathing module; Behavioral: Health coaching

Detailed Description

A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Minnesota HealthSolutions Corporporation
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults, age ≥ 40 years old.
• Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
• At least 10 pack years of smoking.

Exclusion Criteria:

• Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
• Unable to follow commands (cognitive impairment).
• Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
• Live in an area that does not have cellular service (Verizon).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-base pulmonary rehabilitation with mindful breathing modu; Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet.	Behavioral: Home-based pulmonary rehabilitation program; Subjects will wear an activity monitor while doing at home exercises using a computer tablet; Behavioral: Mindful breathing module; Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.; Behavioral: Health coaching; Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
Active Comparator: Home-base pulmonary rehabilitation; Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching	Behavioral: Home-based pulmonary rehabilitation program; Subjects will wear an activity monitor while doing at home exercises using a computer tablet; Behavioral: Health coaching; Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score	The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea.	Baseline, 3 months, 6 months
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score	The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions.	baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily Physical Activity	Mean change in the number of steps per day	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Minnesota HealthSolutions Corporation
• Investigators: Principal Investigator: Kevin Kramer, PhD, Minnesota HealthSolutions Corporation; Principal Investigator: Roberto P Benzo, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): May 7, 2024
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 19-012772; 2R44AT009665-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No