Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Location status: Recruiting
NCT Number: NCT05860803
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).
Interested in participating?
Request Info21 year–80 year
All sexes
Interventional
Not applicable
Jacksonville, Florida, 32224, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: LT-PR
Time frame: Baseline, 8 weeks
Measures the distance walked in meters for 6 minutes.
Time frame: Baseline, 8 weeks
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Time frame: Baseline, 8 weeks
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Time frame: Baseline, 8 weeks
Highest work rate achieved during cardiopulmonary exercise test (treadmill or cycle)
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).
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.
Time frame: Baseline, 8 weeks
Measured by spirometry to determine the largest amount of air inhaled and exhaled during maximal voluntary effort.
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%.
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%.
Time frame: Baseline, 8 weeks
Ultrasound-derived diaphragm thickness, reported centimeters (cm)
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).
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).
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.
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.
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.
Mayo Clinic
Other
Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial
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.
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