Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in six-minute walk test distance
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The study staff who administer clinical testing before and after LT-PR will be blinded to the patient's group allocation.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: LungTrainers (Device)
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).
干预措施: LungTrainers Pulmonary Rehabilitation regime (Behavioral)
结局指标
主要结局
Change in six-minute walk test distance
时间窗: Baseline, 8 weeks
Measures the distance walked in meters for 6 minutes.
Change in peak oxygen uptake during maximal incremental exercise test
时间窗: Baseline, 8 weeks
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
次要结局
- 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)