Breathing Training and Exercise Capacity in Non-CFB

NCT ID: NCT05860803

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2026-12-01

Brief 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).

Conditions

Non-cystic Fibrosis Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group of standard physician directed care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Home-based specific breathing and respiratory muscle training group

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).

Group Type: EXPERIMENTAL

LungTrainers

Intervention Type: DEVICE

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.

LungTrainers Pulmonary Rehabilitation regime

Intervention Type: BEHAVIORAL

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.

Interventions

LungTrainers

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.

Intervention Type: DEVICE

LungTrainers 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

LT-PR

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Bryan Taylor

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bryan Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Federico Simon

Role: primary

Simon.FedericoRey@mayo.edu

904-953-4205

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

22-002736

Identifier Type: -

Identifier Source: org_study_id