Breathing Training and Exercise Capacity in Non-CFB

Mayo Clinic

Status: Enrolling

Conditions: Non-cystic Fibrosis Bronchiectasis

Treatments: Behavioral: LungTrainers Pulmonary Rehabilitation regime; Device: LungTrainers

Study type: Interventional

Funder types: Other

Identifiers

NCT05860803

22-002736

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Control group of standard physician directed care

No Intervention group

Description:

Subjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care').

Home-based specific breathing and respiratory muscle training group

Experimental group

Description:

In addition standard of care pulmonary rehabilitation, subjects will participate in an 8-week home-based specific breathing and respiratory muscle training via the LungTrainers Pulmonary Rehabilitation regime (LT-PR).

Treatment:

Device: LungTrainers

Behavioral: LungTrainers Pulmonary Rehabilitation regime