Nontuberculous Mycobacterial Pulmonary DiseaseNTM-RehabNCT06838442
Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study
An observational study of Nontuberculous Mycobacterial Pulmonary Disease, run by Seoul National University Bundang Hospital at 2 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Pulmonary Disease
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Apr 2025to 25 Nov 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Hyung-Jun Kim, MD, +82-31-787-7844, dr.hjkim@snu.ac.kr
Hyung-Jun Kim, MD
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Beitou Dist, 112201
Jia-Yih Feng, +886-2-2871-2121, peterofeng@gmail.com
Chih-Jung Chang, rhonda610273@gmail.com
About this study
Official title: Rehabilitation Exercise and Education of Airway Clearance Technique in Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study
- 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:
- Does pulmonary rehabilitation and airway clearance training improve lung function, symptom relief, and quality of life in patients with NTM-PD?
- Does this non-pharmacological intervention contribute to better sputum culture conversion rates?
- Participants will:
- Undergo pulmonary rehabilitation and airway clearance training over an 8-week period (biweekly sessions).
- Receive evaluations at baseline, during the intervention, and follow-up assessments at 2 months, 6 months, and final study visit.
- 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).
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2 months, 6 months
6MWT
6 minute walk test distance in meters
Measured: Baseline, 2 months, 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start21 Apr 2025
- Primary completion25 Nov 2028 (estimated)
- Study completion25 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nontuberculous Mycobacterial Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Jun Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838442
- Sponsor's protocol ID
- B-2501-949-303
- Acronym
- NTM-Rehab
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kim HJ, Beom J, Choe B, Ji M, Jo H, Lee KJ, Hwang A, Hwang H, Kwon BS, Park JS, Lee JH. Rehabilitation and airway clearance technique education in nontuberculous mycobacterial pulmonary disease: protocol for the NTM-Rehab study. Tuberc Respir Dis (Seoul). 2026 Sep 10. doi: 10.4046/trd.2026.0164. Online ahead of print.
PubMed 42717669
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Exercise and Education of Airway Clearance Technique in Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06838442
- Acronym / sponsor ID
- NTM-Rehab / B-2501-949-303
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 25 Nov 2028 (estimated)
- Study completion
- 25 Nov 2028 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- Does pulmonary rehabilitation and airway clearance training improve lung function, symptom relief, and quality of life in patients with NTM-PD?
- Does this non-pharmacological intervention contribute to better sputum culture conversion rates?
- Participants will:
- Undergo pulmonary rehabilitation and airway clearance training over an 8-week period (biweekly sessions).
- Receive evaluations at baseline, during the intervention, and follow-up assessments at 2 months, 6 months, and final study visit.
- 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).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months
Time frame: 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
Time frame: 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
Time frame: Baseline, 2 months, 6 months
6 minute walk test distance in meters
3 secondary outcomes
Change in Questionnaire-Bronchiectasis (QOL-B) from Baseline to 6 Months
Time frame: Baseline, 2 months, 6 months
Change in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) from Baseline to 6 Months
Time frame: Baseline, 2 months, 6 months
Severity of radiographic findings
Time frame: Baseline, 2 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 42717669Kim HJ, Beom J, Choe B, Ji M, Jo H, Lee KJ, Hwang A, Hwang H, Kwon BS, Park JS, Lee JH. Rehabilitation and airway clearance technique education in nontuberculous mycobacterial pulmonary disease: protocol for the NTM-Rehab study. Tuberc Respir Dis (Seoul). 2026 Sep 10. doi: 10.4046/trd.2026.0164. Online ahead of print.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nontuberculous Mycobacterial Pulmonary Disease, run by Seoul National University Bundang Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyung-Jun Kim, MD (+82-31-787-7844, dr.hjkim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months (time frame: Baseline, 2 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.