Comparison of Effectiveness Between Active Cycle of Breathing Techniques (ACBT) and Oscillating Positive Expiratory Pressure (OPEP, Aerobika) Device Assisted Treatment in Patients With Bronchiectasis in Korea : Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of Acute Exacerbations in Patients with Bronchiectasis
研究概览
简要总结
Title:
Comparison of Effectiveness Between Active Cycle of Breathing Techniques (ACBT) and Oscillating Positive Expiratory Pressure (OPEP, Aerobika) Device Assisted Treatment in Patients With Bronchiectasis in Korea: A Randomized Controlled Trial
Purpose:
This study aims to evaluate the effectiveness of Active Cycle of Breathing Techniques (ACBT) alone versus ACBT combined with an Oscillating Positive Expiratory Pressure (OPEP) device (Aerobika) in patients with bronchiectasis. The goal is to determine whether the combination therapy reduces the frequency of acute exacerbations and improves patient symptoms compared to ACBT alone.
Primary Questions:
Does the use of ACBT plus Aerobika reduce the number of acute exacerbations in patients with bronchiectasis who experience ≥3 exacerbations per year?
What symptoms and adverse events are observed in participants using the Aerobika device?
Study Design:
This is a single-center, randomized, controlled clinical trial conducted at Chungbuk National University Hospital in Korea. 100 adult patients diagnosed with bronchiectasis and having ≥3 acute exacerbations within 1 year will be enrolled and randomized into two groups (1:1):
Active Cycle of Breathing Technique (ACBT) group
Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group
The intervention period lasts 12 months, with clinic visits scheduled at 0, 1, 3, 6, 9, and 12 months.
Participation Involves:
Use of ACBT with or without Aerobika daily for 12 months
In-person clinic visits every 1 to 3 months
Monthly phone follow-ups to assess symptoms and adverse events
Completion of questionnaires (mMRC, BHQ, CAT) and clinical tests including PFT and laboratory tests
Tracking of exacerbation frequency, sputum volume, and quality
详细描述
Primary Questions:
Does the use of ACBT plus Aerobika reduce the number of acute exacerbations in patients with bronchiectasis who experience ≥3 exacerbations per year?
Answer) To date, no studies have demonstrated that the use of ACBT plus Aerobika reduces acute exacerbations in patients with bronchiectasis who experience frequent exacerbations.
What symptoms and adverse events are observed in participants using the Aerobika device?
Answer) Oscillating PEP devices are not recommended in patients with neuromuscular weakness, recent head and neck surgery or trauma, active hemoptysis, untreated pneumothorax, and middle ear disease
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Patients diagnosed with bronchiectasis involving one or more lobes on chest computed tomography (CT)
- •Patients experiencing frequent exacerbations (3 or more exacerbations) within 1 year
- •Patients able and willing to use the Aerobika device (OPEP)
排除标准
- •Diagnosis of bronchiectasis due to cystic fibrosis
- •Traction bronchiectasis due to interstitial lung disease (ILD)
- •Pregnant patients
- •Patients with a history of OPEP device use
- •Patients who cannot tolerate increased breathing work
- •Hemodynamic instability (e.g., unstable blood pressure)
- •Patients with a past or current history of hemoptysis (pulmonary bleeding) and untreated pneumothorax
研究组 & 干预措施
Active Cycle of Breathing Technique (ACBT) group
patients with bronchiectasis using ACBT
干预措施: Active Cycle of Breathing Technique (ACBT) group (Device)
Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group
Patients with bronchiectasis using ACBT and OPEP simultaneously
干预措施: Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group (Device)
结局指标
主要结局
Frequency of Acute Exacerbations in Patients with Bronchiectasis
时间窗: 12 months from baseline
Number of acute exacerbations experienced by patients diagnosed with bronchiectasis during the 12-month study period.
次要结局
- Improvement in subjective symptoms (1)(Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline)
- Improvement in subjective symptoms (2)(Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline)
- Improvement in subjective symptoms (3)(Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline)
- Improvement in objective assessment(the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (FEV1/FVC): 12 months from baseline)
- Improvement in objective assessment(Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline)
- Improvement in objective assessment(Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %): 12 months from baseline)
- Improvement in objective assessment(Forced Expiratory Volume in 1 second (FEV1) measured in liters (L): 12 months from baseline)
- Improvement in objective assessment(Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of predicted value (FEV1 %): 12 months from baseline)
研究者
Bumhee Yang, MD
Associate professor
Chungbuk National University Hospital