An observational study in Nontuberculous Mycobacterial Pulmonary Disease, sponsored by Seoul National University Bundang Hospital. Recruiting at 2 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Seoul National University Bundang Hospital · Observational
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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:
Seoul National University Bundang Hospital is the lead sponsor of 377 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll adult patients (≥20 years old) diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD) based on the 2020 ATS guidelines. Participants will be recruited from outpatient pulmonary clinics at study sites. 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
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Mycobacterium avium / Mycobacterium intracellulare / Mycobacterium abscessus / Mycobacterium massiliense / Mycobacterium kansasii /
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: Baseline, 2 months, 6 months
6MWT
6 minute walk test distance in meters
Time frame: Baseline, 2 months, 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 months, 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 months, 6 months
Plan to share: Undecided — 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.
Started Apr 2025 (actual). Primary completion is estimated for Nov 2028, 43 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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