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

NCT06838442 | Recruiting

• 1 other identifier: B-2501-949-303
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Nontuberculous Mycobacterial Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months

  Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be measured using pulmonary function tests (PFTs) at baseline, after 2 months, and at 6 months to assess improvements in lung function following pulmonary rehabilitation and airway clearance training.

  Baseline, 2 months, 6 months

• Sputum Culture Conversion Rate

  The percentage of participants achieving sputum culture conversion, defined as three consecutive negative mycobacterial cultures from respiratory samples collected at least one month apart, will be assessed.

  Baseline, 2 months, 6 months

• 6MWT

  6 minute walk test distance in meters

  Baseline, 2 months, 6 months

Secondary Outcomes (3)

• Change in Questionnaire-Bronchiectasis (QOL-B) from Baseline to 6 Months

  Baseline, 2 months, 6 months

• Change in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) from Baseline to 6 Months

  Baseline, 2 months, 6 months

• Severity of radiographic findings

  Baseline, 2 months, 6 months

Other Outcomes (3)

• Change in Physical Function (Grip Strength, 4-Meter Walk Test, Sit-to-Stand Test) from Baseline to 6 Months

  Baseline, 2 months, 6 months

• Adverse Events Related to Pulmonary Rehabilitation and Airway Clearance Techniques

  Throughout study period (up to 6 months)

• Change in body composition: bioimpeance analysis

  Baseline, 2 months, 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adult patients (≥20 years old) diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD) based on the 2020 American Thoracic Society (ATS) guidelines. Participants will be recruited from outpatient pulmonary clinics at Bundang Seoul National University Hospital. Eligible participants will undergo pulmonary rehabilitation and airway clearance training as part of a prospective observational study. The study focuses on assessing the effects of non-pharmacological interventions on lung function, symptom relief, and quality of life in patients with NTM-PD. The cohort will include patients with clinically significant NTM species such as Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium abscessus, Mycobacterium massiliense, and Mycobacterium kansasii. Participants will undergo baseline assessment, structured rehabilitation sessions, and follow-up evaluations at 2 months and 6 months. The study aims to provide real-world clinical evidence sup

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Central Study Contacts

Hyung-Jun Kim, MD

CONTACT

+82-31-787-7844; dr.hjkim@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): November 25, 2028
• Study Completion (Estimated): November 25, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-04

Locations

KR (1)