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

COPD 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: Completed

Administrative data

• NCT number: NCT04517500
• Other study ID #: 19-012772
• Secondary ID: 2R44AT009665-02
• Status: Completed
• Phase: Phase 3
• Start date: August 6, 2021
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COPD
• Respiratory Aspiration

Intervention

Behavioral:
• Home-based pulmonary rehabilitation program
Subjects will wear an activity monitor while doing at home exercises using a computer tablet
• Mindful breathing module
Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.
• Health coaching
Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing

Locations

Country	Name	City	State
United States	Minnesota HealthSolutions Corporporation	Minneapolis	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Minnesota HealthSolutions Corporation, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Summary	The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Dyspnea Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best.	The change from baseline of the CRQ will be assessed at 3 and 6 month.
Primary	Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Summary	The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.	The change from baseline of the CRQ will be assessed at 3 and 6 month.
Secondary	Change in daily Physical Activity- daily steps	An Actigraph activity monitor will be used to measure daily steps and activity counts. The activity monitor is wrist worn for 7 days.	The change from baseline on daily Physical activity will be assessed at 3 and 6 month.