Actively Recruiting

Age: 20Years +
All Genders
ID06838442

Rehabilitation Exercise and Education of Airway Clearance Technique in Nontuberculous Mycobacterial Pulmonary Disease: A Prospective Cohort Study

Led by Seoul National University Bundang Hospital ยท Updated on 2025-06-29

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of pulmonary rehabilitation and airway clearance education in adults diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD). This observational study aims to find out whether these non-drug treatments can improve lung function, relieve symptoms, enhance quality of life, and increase sputum culture conversion rates in patients with NTM-PD. The study is designed to provide evidence that may guide future management of this lung condition. Participants will take part in an 8-week pulmonary rehabilitation program with biweekly sessions. The program includes techniques such as oscillating positive expiratory pressure (OPEP) therapy, high-frequency chest wall oscillation (HFCWO), huffing and coughing methods, breathing exercises, and aerobic and strength training. They will be evaluated at the start, during the intervention, and followed up at 2 months and 6 months after treatment. Throughout the study, participants will undergo pulmonary function tests (measuring FEV1 and FVC), bacteriologic assessments, chest imaging (CT/X-ray), symptom evaluations, and quality of life surveys including EQ-5D-5L and the COPD Assessment Test (CAT) score. Researchers will monitor changes in lung function, sputum culture conversion, exercise capacity (6-minute walk test), and radiographic severity. The total participation period includes these assessments from baseline to 6 months post-intervention.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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, and 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 1 day

Participants undergo baseline assessments including pulmonary function tests, bacteriologic assessments, radiographic imaging, symptom evaluations, and quality of life assessments before starting pulmonary rehabilitation and airway clearance training.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants attend an 8-week biweekly pulmonary rehabilitation program that includes oscillating positive expiratory pressure therapy, high-frequency chest wall oscillation, huffing and coughing techniques, breathing exercises, and aerobic/strength training.

Biweekly visits for 8 weeks

Monitoring

Duration - 6 months

Participants are assessed during treatment and at 2-month and 6-month follow-ups with pulmonary function tests, bacteriologic assessments, radiographic imaging, symptom evaluations, and quality of life assessments to evaluate the effectiveness of the rehabilitation program.

3 visits (baseline, 2 months, and 6 months)

Trial Site Locations

Total: 1 location

1

Seoul National University Bundang Hospital

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

Actively Recruiting

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Research Team

H

Hyung-Jun Kim, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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