Rehabilitation Exercise and Education of Airway Clearance Technique in Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months
研究概览
简要总结
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The goal of this observational study is to evaluate the effects of pulmonary rehabilitation and airway clearance education in adults with nontuberculous mycobacterial pulmonary disease (NTM-PD). The main questions it aims to answer are:
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Does pulmonary rehabilitation and airway clearance training improve lung function, symptom relief, and quality of life in patients with NTM-PD?
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Does this non-pharmacological intervention contribute to better sputum culture conversion rates?
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Participants will:
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Undergo pulmonary rehabilitation and airway clearance training over an 8-week period (biweekly sessions).
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Receive evaluations at baseline, during the intervention, and follow-up assessments at 2 months, 6 months, and final study visit.
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Undergo tests including pulmonary function tests (PFT), symptom assessments, bacteriologic evaluations, radiographic imaging (CT/X-ray), and quality of life surveys (EQ-5D-5L, CAT score).
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This study aims to provide clinical evidence supporting the role of non-pharmacological treatments in the management of NTM-PD, potentially informing future treatment guidelines and improving patient outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older at the time of enrollment.
- •Diagnosis of nontuberculous mycobacterial pulmonary disease (NTM-PD) according to the 2020 American Thoracic Society (ATS) guidelines.
- •Identification of clinically significant NTM species, including:
- •Mycobacterium avium / Mycobacterium intracellulare / Mycobacterium abscessus / Mycobacterium massiliense / Mycobacterium kansasii /
- •Able to undergo pulmonary rehabilitation and airway clearance training as part of the study protocol.
- •Willing to provide written informed consent to participate in the study.
排除标准
- •Currently pregnant or actively breastfeeding.
- •Unable to participate in pulmonary rehabilitation due to severe mobility impairment or neuromuscular disorders.
- •History of massive hemoptysis or other medical conditions where airway clearance techniques may be contraindicated.
结局指标
主要结局
Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months
时间窗: Baseline, 2 months, 6 months
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be measured using pulmonary function tests (PFTs) at baseline, after 2 months, and at 6 months to assess improvements in lung function following pulmonary rehabilitation and airway clearance training.
Sputum Culture Conversion Rate
时间窗: Baseline, 2 months, 6 months
The percentage of participants achieving sputum culture conversion, defined as three consecutive negative mycobacterial cultures from respiratory samples collected at least one month apart, will be assessed.
6MWT
时间窗: Baseline, 2 months, 6 months
6 minute walk test distance in meters
次要结局
- Change in Questionnaire-Bronchiectasis (QOL-B) from Baseline to 6 Months(Baseline, 2 months, 6 months)
- Change in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) from Baseline to 6 Months(Baseline, 2 months, 6 months)
- Severity of radiographic findings(Baseline, 2 months, 6 months)
研究者
Hyung-Jun Kim
Professor
Seoul National University Bundang Hospital