Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study
NCT ID: NCT06838442
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-04-21
2028-11-25
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Hyung-Jun Kim
Professor
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B-2501-949-303
Identifier Type: -
Identifier Source: org_study_id
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