Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in six-minute walk test distance
Study Overview
Brief 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 (non-CFB).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The study staff who administer clinical testing before and after LT-PR will be blinded to the patient's group allocation.
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group of standard physician directed care
Subjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care').
Home-based specific breathing and respiratory muscle training group
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).
Intervention: LungTrainers Pulmonary Rehabilitation regime (Behavioral)
Home-based specific breathing and respiratory muscle training group
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).
Intervention: LungTrainers (Device)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in exercise time during maximal incremental exercise test(Baseline, 8 weeks)
- Change in diaphragm thickness(Baseline, 8 weeks)
- Change in forced expiratory volume in 1 second(Baseline, 8 weeks)
- Change in diaphragm excursion(Baseline, 8 weeks)
- Change in maximal voluntary ventilation(Baseline, 8 weeks)
- Change in maximal inspiratory pressure(Baseline, 8 weeks)
- Change in maximal expiratory mouth pressure(Baseline, 8 weeks)
- Change in diaphragm thickening fraction(Baseline, 8 weeks)
- Change in Dartmouth COOP Functional Assessment Charts(Baseline, 8 weeks)
- Peak exercise work rate during maximal incremental exercise test(Baseline, 8 weeks)
- Change in forced vital capacity(Baseline, 8 weeks)
- Change in St. George's Respiratory Questionnaire (SGRQ)(Baseline, 8 weeks)
- Change in Modified Medical Research Council Dyspnea Scale (mMRC)(Baseline, 8 weeks)
Investigators
Bryan Taylor
Principal Investigator
Mayo Clinic