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

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Mayo Clinic

Status and phase

Completed
Phase 3

Conditions

COPD

Treatments

Behavioral: Health coaching
Behavioral: Home-based pulmonary rehabilitation program
Behavioral: Mindful breathing module

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04517500
2R44AT009665-02 (U.S. NIH Grant/Contract)
19-012772

Details and patient eligibility

About

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.

Full 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.

Enrollment

99 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

99 participants in 2 patient groups

Home-base pulmonary rehabilitation with mindful breathing modu
Experimental group
Description:
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.
Treatment:
Behavioral: Mindful breathing module
Behavioral: Home-based pulmonary rehabilitation program
Behavioral: Health coaching
Home-base pulmonary rehabilitation
Active Comparator group
Description:
Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching
Treatment:
Behavioral: Home-based pulmonary rehabilitation program
Behavioral: Health coaching

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Johanna Hoult

Data sourced from clinicaltrials.gov

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