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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTM-PD Pulmonary Rehabilitation Cohort | This cohort consists of adults diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD) who will undergo pulmonary rehabilitation and airway clearance training as part of a prospective observational study. Participants will receive an 8-week biweekly pulmonary rehabilitation program, including oscillating positive expiratory pressure (OPEP) therapy, high-frequency chest wall oscillation (HFCWO), huffing and coughing techniques, breathing exercises, and aerobic/strength training. They will be monitored at baseline, during treatment, and at 2-month and 6-month follow-ups, undergoing pulmonary function tests (PFT), bacteriologic assessments, radiographic imaging (CT/X-ray), symptom evaluations, and quality of life assessments (EQ-5D-5L, CAT score). This study aims to assess the effectiveness of non-pharmacological interventions in improving respiratory function, reducing symptoms, and enhancing quality of life in NTM-PD patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Function (FEV1 and FVC) from Baseline to 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. | Baseline, 2 months, 6 months |
| Sputum Culture Conversion Rate | 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. | Baseline, 2 months, 6 months |
| 6MWT | 6 minute walk test distance in meters | Baseline, 2 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Questionnaire-Bronchiectasis (QOL-B) from Baseline to 6 Months | Quality of life improvements will be assessed using Questionnaire-Bronchiectasis (QOL-B). The questionnaire comprised a total of 37 items, covering domains such as physical functioning (5 items), role functioning (5 items), vitality (3 items), emotional functioning (4 items), social functioning (4 items), health perception (4 items), respiratory symptoms (9 items), and treatment burden (3 items). Each domain score ranged from 0 to 100, with higher scores indicating better quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Function (Grip Strength, 4-Meter Walk Test, Sit-to-Stand Test) from Baseline to 6 Months | Physical function will be assessed using hand-grip strength measurements, a 4-meter walk test, and a sit-to-stand test to evaluate improvements in muscle strength and mobility. | Baseline, 2 months, 6 months |
Inclusion Criteria:
Mycobacterium avium / Mycobacterium intracellulare / Mycobacterium abscessus / Mycobacterium massiliense / Mycobacterium kansasii /
Exclusion Criteria:
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This study will enroll adult patients (≥20 years old) diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD) based on the 2020 American Thoracic Society (ATS) guidelines. Participants will be recruited from outpatient pulmonary clinics at Bundang Seoul National University Hospital. Eligible participants will undergo pulmonary rehabilitation and airway clearance training as part of a prospective observational study. The study focuses on assessing the effects of non-pharmacological interventions on lung function, symptom relief, and quality of life in patients with NTM-PD.
The cohort will include patients with clinically significant NTM species such as Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium abscessus, Mycobacterium massiliense, and Mycobacterium kansasii. Participants will undergo baseline assessment, structured rehabilitation sessions, and follow-up evaluations at 2 months and 6 months. The study aims to provide real-world clinical evidence sup
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyung-Jun Kim, MD | Contact | +82-31-787-7844 | dr.hjkim@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
At this time, there is no plan to publicly share individual participant data (IPD) due to patient confidentiality and ethical considerations. However, de-identified, aggregated data may be made available upon reasonable request for collaborative research purposes, subject to appropriate ethical approvals and institutional review board (IRB) regulations. If data sharing becomes feasible, it will follow applicable regulations and data protection guidelines.
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| Baseline, 2 months, 6 months |
| Change in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) from Baseline to 6 Months | EuroQoL 5-Dimension 5-Level (EQ-5D-5L) includes quality of life assessments including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores can range from 11111 to 55555, with lower scores referring tobetter quality of life. | Baseline, 2 months, 6 months |
| Severity of radiographic findings | High-resolution computed tomography (HRCT) and chest X-rays will be used to evaluate changes in lung structure, including bronchiectasis severity and cavitary lesions. Presence and size of cavities will be measured in chest CT, and artificial intelligenced-based scoring systems will be used to measure radiographic severity in chest X-rays. | Baseline, 2 months, 6 months |
| Adverse Events Related to Pulmonary Rehabilitation and Airway Clearance Techniques |
The incidence of adverse events such as fatigue, muscle pain, hemoptysis, and respiratory distress related to pulmonary rehabilitation interventions will be monitored and documented. |
| Throughout study period (up to 6 months) |
| Change in body composition: bioimpeance analysis | Change in body composition will be assesed using the bioimpedance analysis. It provides resistance and reactance measured at different frequency currents, providing estimations of the body fat mass (kg), protein mass (kg), and skeletal muscle mass (kg). Volume of body water (L) and percentage of body fat (%) will be calculated as well. | Baseline, 2 months, 6 months |