Breathing Training and Exercise Capacity in Non-CFB

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT05860803
Status
Recruiting
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Conditions

  • Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • LungTrainers — 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 — 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.

Study Details

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).

Key Dates

Start date
Jan 15, 2024
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Change in six-minute walk test distance [ Time Frame: Baseline, 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic FloridaJacksonvilleFlorida32224
Federico Simon
[email protected]
904-953-4205

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Mayo Clinic Florida· Jacksonville, FL

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