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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

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

    Recruiting

Other trials in United States

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).

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 groups in NCT05860803
Study groupRoleWhat they receive
Control group of standard physician directed careNo interventionSubjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care').
Home-based specific breathing and respiratory muscle training groupExperimentalIn 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.

  1. Change in six-minute walk test distance

    Measures the distance walked in meters for 6 minutes.

    Measured: Baseline, 8 weeks

  2. 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)
  1. 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

  2. Peak exercise work rate during maximal incremental exercise test

    Highest work rate achieved during cardiopulmonary exercise test (treadmill or cycle)

    Measured: Baseline, 8 weeks

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Change in diaphragm thickness

    Ultrasound-derived diaphragm thickness, reported centimeters (cm)

    Measured: Baseline, 8 weeks

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted16 May 2023
  2. Study start15 Jan 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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)
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

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.

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