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Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study (NTM-Rehab)

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Seoul National University

Status

Enrolling

Conditions

Nontuberculous Mycobacterial Pulmonary Disease

Study type

Observational

Funder types

Other

Identifiers

NCT06838442
B-2501-949-303

Details and patient eligibility

About

  • 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.

Enrollment

500 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

NTM-PD Pulmonary Rehabilitation Cohort
Description:
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.

Trial contacts and locations

1

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Central trial contact

Hyung-Jun Kim, MD

Data sourced from clinicaltrials.gov

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