RecruitingNot ApplicableNCT05860803

Breathing Training and Exercise Capacity in Non-CFB

Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial


Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to investigate whether a home-based and health coach supported specific breathing and respiratory muscle training program improves the ability to exercise, the function of the lungs and breathing muscles, and general clinical status in people with non-cystic fibrosis bronchiectasis (non-CFB).


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria2

  • Mayo Clinic patient with confirmed diagnosis of Non-Cystic Fibrosis Bronchiectasis (non-CFB): Non-CFB as confirmed by clinical history, including cough, shortness of breath, exertional dyspnea, pulmonary function tests, and high-resolution computed tomography. Patients will be considered clinically stable if there is no evidence of an exacerbation or change(s) in medical therapy in the previous three weeks.
  • Able and willing to provide informed consent to participate in the study.

Exclusion Criteria5

  • Presence of significant coexisting disease, neurological conditions, and/or orthopedic complications that affect ability to undertake exercise.
  • Presence of advanced heart failure.
  • Current use of antibiotics.
  • Acute exacerbation(s) within 3-weeks prior to study commencement.
  • Participation within a pulmonary rehabilitation program within 6-months prior to study commencement.

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Interventions

DEVICELungTrainers

A training device that provides a variable resistance against which users breathe out. Users breathe through a plastic mouthpiece that is connected to an acrylic cylinder via rubber tubing. The mouthpiece has several small holes of various diameters and up to three stainless steel weights (half-weight increments) can be inserted into the acrylic tube. With each breath-out, the user exhales against the resistance provided by the weight inserts, and each inspiration (i.e., breath-in) is unresisted. During each resisted exhalation, the weight inserts are 'lifted' within the acrylic tube depending on the level of expiratory pressure generated by the participant.

BEHAVIORALLungTrainers Pulmonary Rehabilitation regime

Series of different exercises using the LungTrainers device 3-5 days per week for approximately 10 weeks. Exercises complete in one long session (20-30 minutes) or be broken down into multiple shorter sessions (e.g., 3 x 10 minutes). A health coach will be assigned to guide participants through the LT-PR program.


Locations(1)

Mayo Clinic Florida

Jacksonville, Florida, United States

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NCT05860803


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