Clinical trial NCT06838442: Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study
Official title: Rehabilitation Exercise and Education of Airway Clearance Technique in Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nontuberculous Mycobacterial Pulmonary Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months
timeFrame: Baseline, 2 months, 6 months
measure: Sputum Culture Conversion Rate
timeFrame: Baseline, 2 months, 6 months
Secondary outcomes:
measure: Change in Questionnaire-Bronchiectasis (QOL-B) from Baseline to 6 Months
timeFrame: Baseline, 2 months, 6 months
measure: Change in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) from Baseline to 6 Months
timeFrame: Baseline, 2 months, 6 months
measure: Severity of radiographic findings
timeFrame: Baseline, 2 months, 6 months
Other outcomes:
measure: Change in Physical Function (Grip Strength, 4-Meter Walk Test, Sit-to-Stand Test) from Baseline to 6 Months
timeFrame: Baseline, 2 months, 6 months
measure: Adverse Events Related to Pulmonary Rehabilitation and Airway Clearance Techniques
timeFrame: Throughout study period (up to 6 months)
measure: Change in body composition: bioimpeance analysis
timeFrame: Baseline, 2 months, 6 months
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: