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Completed

NCT Number: NCT04517500

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

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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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Minnesota HealthSolutions Corporporation, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Home-based pulmonary rehabilitation program

Behavioral

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

Mindful breathing module

Behavioral

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

Health Coaching

Behavioral

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

Primary outcomes

  1. Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score

    Time frame: Baseline, 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.

  2. Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score

    Time frame: baseline, 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 outcomes

  1. Change in Daily Physical Activity

    Time frame: baseline, 3 months, 6 months

    Mean change in the number of steps per day

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Minnesota HealthSolutions
  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2020
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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