Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nontuberculous Mycobacterial Pulmonary Disease. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rehabilitation Exercise and Education of Airway Clearance Technique in Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study
Overview
* 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.
Primary outcome measures
- Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months [Time frame: Baseline, 2 months, 6 months]
- Sputum Culture Conversion Rate [Time frame: Baseline, 2 months, 6 months]
- 6MWT [Time frame: Baseline, 2 months, 6 months]
Secondary outcome measures (3)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Identifiers
NCT: NCT06838442 · B-2501-949-303