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

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.