MedPath

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

Phase 3
Completed
Conditions
COPD
Interventions
Behavioral: Home-based pulmonary rehabilitation program
Behavioral: Health coaching
Behavioral: Mindful breathing module
Registration Number
NCT04517500
Lead Sponsor
Mayo Clinic
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
99
Inclusion Criteria
  • Adults, age ≥ 40 years old.
  • Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
  • At least 10 pack years of smoking.
Read More
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).
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Home-base pulmonary rehabilitationHealth coachingSubjects will complete 12 week home-based pulmonary rehabilitation with health coaching
Home-base pulmonary rehabilitation with mindful breathing moduMindful breathing moduleSubjects 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.
Home-base pulmonary rehabilitation with mindful breathing moduHealth coachingSubjects 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.
Home-base pulmonary rehabilitationHome-based pulmonary rehabilitation programSubjects will complete 12 week home-based pulmonary rehabilitation with health coaching
Home-base pulmonary rehabilitation with mindful breathing moduHome-based pulmonary rehabilitation programSubjects 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.
Primary Outcome Measures
NameTimeMethod
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea ScoreBaseline, 3 months, 6 months

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.

Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Scorebaseline, 3 months, 6 months

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.

Secondary Outcome Measures
NameTimeMethod
Change in Daily Physical Activitybaseline, 3 months, 6 months

Mean change in the number of steps per day

Trial Locations

Locations (2)

Minnesota HealthSolutions Corporporation

🇺🇸

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath