Breathing Training and Exercise Capacity in Non-CFB
ConditionNon-cystic Fibrosis Bronchiectasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorMayo Clinic
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LungTrainers
DeviceA 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
BehavioralSeries 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Control group of standard physician directed careNo intervention 0 interventions
Group B: Home-based specific breathing and respiratory muscle training groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in six-minute walk test distance
Measures the distance walked in meters for 6 minutes.
Time frame
Baseline, 8 weeks2
Change in peak oxygen uptake during maximal incremental exercise test
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Time frame
Baseline, 8 weeksSecondary outcomes
1
Change in exercise time during maximal incremental exercise test
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Time frame
Baseline, 8 weeks2
Peak exercise work rate during maximal incremental exercise test
Highest work rate achieved during cardiopulmonary exercise test (treadmill or cycle)
Time frame
Baseline, 8 weeks3
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).
Time frame
Baseline, 8 weeks4
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.
Time frame
Baseline, 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov