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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-06

Study Completion Date

2024-05-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Half of the participants will be randomized to receive the home-based PR with the mindful breathing module which consists of the Pursed Lipped Breathing Application and the Spire Health Tags (intervention) and half will receive the home-based PR (control).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Home-based pulmonary rehabilitation program

Intervention Type BEHAVIORAL

Subjects will wear an activity monitor while doing at home exercises using a computer tablet

Mindful breathing module

Intervention Type BEHAVIORAL

Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.

Health coaching

Intervention Type BEHAVIORAL

Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing

Home-base pulmonary rehabilitation

Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching

Group Type ACTIVE_COMPARATOR

Home-based pulmonary rehabilitation program

Intervention Type BEHAVIORAL

Subjects will wear an activity monitor while doing at home exercises using a computer tablet

Health coaching

Intervention Type BEHAVIORAL

Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing

Interventions

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Home-based pulmonary rehabilitation program

Subjects will wear an activity monitor while doing at home exercises using a computer tablet

Intervention Type BEHAVIORAL

Mindful breathing module

Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.

Intervention Type BEHAVIORAL

Health coaching

Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No