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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-21

Study Completion Date

2028-11-25

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Nontuberculous Mycobacterial Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Jun Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyung-Jun Kim, MD

Role: CONTACT

+82-31-787-7844

Facility Contacts

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Hyung-Jun Kim, MD

Role: primary

+82-31-787-7844

Other Identifiers

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B-2501-949-303

Identifier Type: -

Identifier Source: org_study_id

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