Breathing Training and Exercise Capacity in Non-CFB

Официальное название

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

Обзор

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).

Вмешательства

• Устройство 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
• Поведенческое 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.

Первичные конечные точки

• Change in six-minute walk test distance [Срок оценки: Baseline, 8 weeks]
• Change in peak oxygen uptake during maximal incremental exercise test [Срок оценки: Baseline, 8 weeks]

Вторичные конечные точки (12)

• Change in exercise time during maximal incremental exercise test [Срок оценки: Baseline, 8 weeks]
• Peak exercise work rate during maximal incremental exercise test [Срок оценки: Baseline, 8 weeks]
• Change in forced vital capacity [Срок оценки: Baseline, 8 weeks]
• Change in forced expiratory volume in 1 second [Срок оценки: Baseline, 8 weeks]
• Change in maximal voluntary ventilation [Срок оценки: Baseline, 8 weeks]
• Change in maximal inspiratory pressure [Срок оценки: Baseline, 8 weeks]
• Change in maximal expiratory mouth pressure [Срок оценки: Baseline, 8 weeks]
• Change in diaphragm thickness [Срок оценки: Baseline, 8 weeks]
• Change in diaphragm thickening fraction [Срок оценки: Baseline, 8 weeks]
• Change in diaphragm excursion [Срок оценки: Baseline, 8 weeks]
• Change in Modified Medical Research Council Dyspnea Scale (mMRC) [Срок оценки: Baseline, 8 weeks]
• Change in St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: Baseline, 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic Florida — Jacksonville

Идентификаторы

NCT: NCT05860803 · 22-002736

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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