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Recruiting NCT05860803

Breathing Training and Exercise Capacity in Non-CFB

No phase Interventional Non-cystic Fibrosis Bronchiectasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LungTrainers, LungTrainers Pulmonary Rehabilitation regime.
Who it may be relevant to
Registry conditions: Non-cystic Fibrosis Bronchiectasis. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • Device LungTrainers
    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
  • Behavioral LungTrainers Pulmonary Rehabilitation regime
    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.

Primary outcome measures

  • Change in six-minute walk test distance [Time frame: Baseline, 8 weeks]
  • Change in peak oxygen uptake during maximal incremental exercise test [Time frame: Baseline, 8 weeks]
Secondary outcome measures (12)
  • Change in exercise time during maximal incremental exercise test [Time frame: Baseline, 8 weeks]
  • Peak exercise work rate during maximal incremental exercise test [Time frame: Baseline, 8 weeks]
  • Change in forced vital capacity [Time frame: Baseline, 8 weeks]
  • Change in forced expiratory volume in 1 second [Time frame: Baseline, 8 weeks]
  • Change in maximal voluntary ventilation [Time frame: Baseline, 8 weeks]
  • Change in maximal inspiratory pressure [Time frame: Baseline, 8 weeks]
  • Change in maximal expiratory mouth pressure [Time frame: Baseline, 8 weeks]
  • Change in diaphragm thickness [Time frame: Baseline, 8 weeks]
  • Change in diaphragm thickening fraction [Time frame: Baseline, 8 weeks]
  • Change in diaphragm excursion [Time frame: Baseline, 8 weeks]
  • Change in Modified Medical Research Council Dyspnea Scale (mMRC) [Time frame: Baseline, 8 weeks]
  • Change in St. George's Respiratory Questionnaire (SGRQ) [Time frame: Baseline, 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic Florida — Jacksonville

Identifiers

NCT: NCT05860803 · 22-002736

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗