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OpenTrials
Completed

NCT Number: NCT03198780

Mindful Breathing Awareness Through Pursed-Lip Breathing Training

To establish the feasibility of a tool that monitors and motivates people with COPD to complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at home.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

For this pilot study patients who meet the conventional criteria for pulmonary rehabilitation at their clinical appointments will be recruited and scheduled to return for the study. After completing the informed consent, patients will be taught how to don and doff the pulse oximeter, the source of the heart rate and oxygen signals. Patients will participate in a demonstration on how to perform the intervention. Recruitment will continue until five patients have completed the pilot in a clinic setting. If necessary, the prototype will be modified and testing resumed. Once the prototype system has met the criteria for success in the clinic, five of patients will be asked to use the prototype at the clinic and to take it home for a week and perform the intervention at least five times.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must be ≥40 years old
  • have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing
  • have clinically significant breathlessness (breathless when walking on the level or walking a mild hill)
  • be a current or previous smoker with at least 10 pack-years of cigarette smoking
  • be hospitalized for an exacerbation of COPD.

Exclusion criteria

  • Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
  • Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Treatment and study plan

Breathing Awareness

Other

Participants will use a pulse-oximeter and biofeedback app to guide them through pursed-lip breathing training.

Primary outcomes

  1. Participant assessment of device feasibility

    Time frame: up to 1 week

    Participants in both arms will complete a subjective questionnaire to elicit information about their experience and opinions about the intervention

Secondary outcomes

  1. Device Use Assessed by Pulse Oximetry Data

    Time frame: up to 1 week

    The system will track data on each patient's breathing pattern to assess whether they are following the program

Sponsors and collaborators

Lead sponsor

Minnesota HealthSolutions

Industry

Collaborators

  • Mayo Clinic

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
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2017
Registry last updated
Oct 29, 2019

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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