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
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 16, 2023
CompletedStudy Start
First participant enrolled
January 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 6, 2026
January 1, 2026
2.9 years
May 8, 2023
January 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in six-minute walk test distance
Measures the distance walked in meters for 6 minutes.
Baseline, 8 weeks
Change in peak oxygen uptake during maximal incremental exercise test
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Baseline, 8 weeks
Secondary Outcomes (13)
Change in exercise time during maximal incremental exercise test
Baseline, 8 weeks
Peak exercise work rate during maximal incremental exercise test
Baseline, 8 weeks
Change in forced vital capacity
Baseline, 8 weeks
Change in forced expiratory volume in 1 second
Baseline, 8 weeks
Change in maximal voluntary ventilation
Baseline, 8 weeks
- +8 more secondary outcomes
Study Arms (2)
Control group of standard physician directed care
NO INTERVENTIONSubjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care').
Home-based specific breathing and respiratory muscle training group
EXPERIMENTALIn 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Taylor, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The study staff who administer clinical testing before and after LT-PR will be blinded to the patient's group allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 16, 2023
Study Start
January 15, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share