Recruiting

Breathing Training

Sponsor:

Mayo Clinic

Code:

NCT05860803

Conditions

Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

LungTrainers

LungTrainers Pulmonary Rehabilitation regime

Study Details

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 ID

NCT05860803

Start date

Jan 15, 2024

Status verified date

Jan, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control group of standard physician directed care

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

experimental: 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).

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.

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.

Primary outcome measure

  • Change in six-minute walk test distance [ Time Frame: Baseline, 8 weeks ]
  • Change in peak oxygen uptake during maximal incremental exercise test [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Federico Simon

904-953-4205Simon.FedericoRey@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-06.