Non-cystic Fibrosis BronchiectasisNCT05860803
Breathing Training and Exercise Capacity in Non-CFB
A study testing LungTrainers and LungTrainers Pulmonary Rehabilitation regime in people with Non-cystic Fibrosis Bronchiectasis, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- LungTrainers and LungTrainers Pulmonary Rehabilitation regime
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Federico Simon, 904-953-4205, Simon.FedericoRey@mayo.edu
About this study
Official title: Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial
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
- Being tested
- LungTrainers, LungTrainers Pulmonary Rehabilitation regime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungTrainersDevice
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 regimeBehavioural
Also called LT-PR
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 group | Role | What they receive |
|---|---|---|
| Control group of standard physician directed care | No intervention | Subjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care'). |
| Home-based specific breathing and respiratory muscle training group | Experimental | 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). Receives: Device: LungTrainers; Behavioral: LungTrainers Pulmonary Rehabilitation regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six-minute walk test distance
Measures the distance walked in meters for 6 minutes.
Measured: 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).
Measured: Baseline, 8 weeks
Secondary outcomes (13)
Change in exercise time during maximal incremental exercise test
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Measured: Baseline, 8 weeks
Peak exercise work rate during maximal incremental exercise test
Highest work rate achieved during cardiopulmonary exercise test (treadmill or cycle)
Measured: Baseline, 8 weeks
Change in forced vital capacity
Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L).
Measured: Baseline, 8 weeks
Change in forced expiratory volume in 1 second
Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath.
Measured: Baseline, 8 weeks
Change in maximal voluntary ventilation
Measured by spirometry to determine the largest amount of air inhaled and exhaled during maximal voluntary effort.
Measured: Baseline, 8 weeks
Change in maximal inspiratory pressure
Assessed using a calibrated pressure meter to evaluate inspiratory muscle strength. After exhaling slowly and maximally (i.e., to residual volume), the subject will be urged strongly to 'suck-in as maximally as possible' (Mueller maneuver) for approximately 3 to 5 seconds. Measured by 3-5 repetitions and defined as the highest value (in cmH2O) of three measurements that vary by ≤5%.
Measured: Baseline, 8 weeks
Change in maximal expiratory mouth pressure
Assessed using a calibrated pressure meter to evaluate expiratory muscle strength. After inhaling slowly and maximally (i.e., to total lung capacity), the patient will be strongly urged to 'blow-out as maximally as possible' (Valsalva maneuver) for approximately 3 to 5 seconds. Measured by 3-5 repetitions and defined as the highest value (in cmH2O) of three measurements that vary by ≤5%.
Measured: Baseline, 8 weeks
Change in diaphragm thickness
Ultrasound-derived diaphragm thickness, reported centimeters (cm)
Measured: Baseline, 8 weeks
Change in diaphragm thickening fraction
Ultrasound-derived diaphragm thickening fraction defined as ratio of at total lung capacity thickness at functional residual capacity to thickness at functional residual capacity, reported in millimeters (mm).
Measured: Baseline, 8 weeks
Change in diaphragm excursion
Ultrasound-derived diaphragm excursion defined as the amplitude of excursion from baseline to the point of maximum height during the sniff, reported in centimeters (cm).
Measured: Baseline, 8 weeks
Change in Modified Medical Research Council Dyspnea Scale (mMRC)
mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 which 0=no breathlessness except on strenuous exercise; 1=shortness of breath when hurrying on the level or walking up a slight hill; 2=walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3=stops for breath after walking approximately 100 m or after few minutes on the level; and 4=too breathless to leave the house, or breathless when dressing or undressing.
Measured: Baseline, 8 weeks
Change in St. George's Respiratory Questionnaire (SGRQ)
SGRQ measures impact on overall health, daily life, and perceived well-being in patients with lung disease, specifically obstructive airways disease. The questionnaire consists of two parts with three components; Part 1: symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Baseline, 8 weeks
Change in Dartmouth COOP Functional Assessment Charts
The Dartmouth COOP chart consists of nine questions measuring seven domains of health status: physical fitness, feelings, daily activities, social activities, change in health status, current overall health perceptions, bodily pain, social support, and quality of life. Each question has five response options.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Taylor, Mayo Clinic
- Investigators
- Bryan Taylor, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860803
- Sponsor's protocol ID
- 22-002736
- Status last verified
- Jan 2026
- First submitted
- 8 May 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05860803
- Acronym / sponsor ID
- 22-002736
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group of standard physician directed care | No intervention | –Subjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care'). |
| Home-based specific breathing and respiratory muscle training group | Experimental | Device: LungTrainers, Behavioral: LungTrainers Pulmonary Rehabilitation regimeIn 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). |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LungTrainersA 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. | Device | Home-based specific breathing and respiratory muscle training group |
| LungTrainers Pulmonary Rehabilitation regimeAlso: LT-PRSeries 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. | Behavioural | Home-based specific breathing and respiratory muscle training group |
Primary outcome
Change in six-minute walk test distance
Time frame: Baseline, 8 weeks
Measures the distance walked in meters for 6 minutes.
Change in peak oxygen uptake during maximal incremental exercise test
Time frame: Baseline, 8 weeks
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
13 secondary outcomes
Change in exercise time during maximal incremental exercise test
Time frame: Baseline, 8 weeks
Peak exercise work rate during maximal incremental exercise test
Time frame: Baseline, 8 weeks
Change in forced vital capacity
Time frame: Baseline, 8 weeks
Change in forced expiratory volume in 1 second
Time frame: Baseline, 8 weeks
Change in maximal voluntary ventilation
Time frame: Baseline, 8 weeks
Change in maximal inspiratory pressure
Time frame: Baseline, 8 weeks
Change in maximal expiratory mouth pressure
Time frame: Baseline, 8 weeks
Change in diaphragm thickness
Time frame: Baseline, 8 weeks
Change in diaphragm thickening fraction
Time frame: Baseline, 8 weeks
Change in diaphragm excursion
Time frame: Baseline, 8 weeks
Change in Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: Baseline, 8 weeks
Change in St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline, 8 weeks
Change in Dartmouth COOP Functional Assessment Charts
Time frame: Baseline, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Active, not recruitingObservational study
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis
RecruitingPhase 2
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingPhase 1
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
RecruitingObservational study
Regional Phenotyping of CF and Non-CF Bronchiectasis
Cystic Fibrosis, Non-CF Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan Taylor, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LungTrainers and LungTrainers Pulmonary Rehabilitation regime in people with Non-cystic Fibrosis Bronchiectasis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in six-minute walk test distance (time frame: Baseline, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.