Clinical trial NCT05860803: Breathing Training and Exercise Capacity in Non-CFB
Official title: Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-cystic Fibrosis Bronchiectasis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in six-minute walk test distance
timeFrame: Baseline, 8 weeks
measure: Change in peak oxygen uptake during maximal incremental exercise test
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in exercise time during maximal incremental exercise test
timeFrame: Baseline, 8 weeks
measure: Peak exercise work rate during maximal incremental exercise test
timeFrame: Baseline, 8 weeks
measure: Change in forced vital capacity
timeFrame: Baseline, 8 weeks
measure: Change in forced expiratory volume in 1 second
timeFrame: Baseline, 8 weeks
measure: Change in maximal voluntary ventilation
timeFrame: Baseline, 8 weeks
measure: Change in maximal inspiratory pressure
timeFrame: Baseline, 8 weeks
measure: Change in maximal expiratory mouth pressure
timeFrame: Baseline, 8 weeks
measure: Change in diaphragm thickness
timeFrame: Baseline, 8 weeks
measure: Change in diaphragm thickening fraction
timeFrame: Baseline, 8 weeks
measure: Change in diaphragm excursion
timeFrame: Baseline, 8 weeks
measure: Change in Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: Baseline, 8 weeks
measure: Change in St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline, 8 weeks
measure: Change in Dartmouth COOP Functional Assessment Charts
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bryan Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: