Clinical trial NCT04517500: A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients
Official title: A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Minnesota HealthSolutions
First posted: 2020-08-18
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in Daily Physical Activity
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minnesota HealthSolutions Corporporation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota HealthSolutions
name: Kevin Kramer, PhD
role: PRINCIPAL_INVESTIGATOR
References: