Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05860803

Breathing Training and Exercise Capacity in Non-CFB

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Federico Simon

CONTACT

[email protected]

904-953-4205

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: LT-PR

Primary outcomes

  1. Change in six-minute walk test distance

    Time frame: Baseline, 8 weeks

    Measures the distance walked in meters for 6 minutes.

  2. 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).

Secondary outcomes

  1. Change in exercise time during maximal incremental exercise test

    Time frame: Baseline, 8 weeks

    Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).

  2. Peak exercise work rate during maximal incremental exercise test

    Time frame: Baseline, 8 weeks

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

  3. Change in forced vital capacity

    Time frame: Baseline, 8 weeks

    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).

  4. Change in forced expiratory volume in 1 second

    Time frame: Baseline, 8 weeks

    Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath.

  5. Change in maximal voluntary ventilation

    Time frame: Baseline, 8 weeks

    Measured by spirometry to determine the largest amount of air inhaled and exhaled during maximal voluntary effort.

  6. Change in maximal inspiratory pressure

    Time frame: Baseline, 8 weeks

    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%.

  7. Change in maximal expiratory mouth pressure

    Time frame: Baseline, 8 weeks

    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%.

  8. Change in diaphragm thickness

    Time frame: Baseline, 8 weeks

    Ultrasound-derived diaphragm thickness, reported centimeters (cm)

  9. Change in diaphragm thickening fraction

    Time frame: Baseline, 8 weeks

    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).

  10. Change in diaphragm excursion

    Time frame: Baseline, 8 weeks

    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).

  11. Change in Modified Medical Research Council Dyspnea Scale (mMRC)

    Time frame: Baseline, 8 weeks

    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.

  12. Change in St. George's Respiratory Questionnaire (SGRQ)

    Time frame: Baseline, 8 weeks

    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.

  13. Change in Dartmouth COOP Functional Assessment Charts

    Time frame: Baseline, 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 16, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.