NCT05860803

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-05-16
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study