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NCT Number: NCT06838442

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

* 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.

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Key information

Conditions

Nontuberculous Mycobacterial Pulmonary Disease

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

Location status: Recruiting

Location contact

Hyung-Jun Kim, MD

CONTACT

[email protected]

+82-31-787-7844

Hyung-Jun Kim, MD

PRINCIPAL_INVESTIGATOR

Jaewon Beom, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline, 2 months, 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.

  2. Sputum Culture Conversion Rate

    Time frame: Baseline, 2 months, 6 months

    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.

  3. 6MWT

    Time frame: Baseline, 2 months, 6 months

    6 minute walk test distance in meters

Secondary outcomes

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

    Time frame: Baseline, 2 months, 6 months

    Quality of life improvements will be assessed using Questionnaire-Bronchiectasis (QOL-B). The questionnaire comprised a total of 37 items, covering domains such as physical functioning (5 items), role functioning (5 items), vitality (3 items), emotional functioning (4 items), social functioning (4 items), health perception (4 items), respiratory symptoms (9 items), and treatment burden (3 items). Each domain score ranged from 0 to 100, with higher scores indicating better quality of life.

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

    Time frame: Baseline, 2 months, 6 months

    EuroQoL 5-Dimension 5-Level (EQ-5D-5L) includes quality of life assessments including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores can range from 11111 to 55555, with lower scores referring tobetter quality of life.

  3. Severity of radiographic findings

    Time frame: Baseline, 2 months, 6 months

    High-resolution computed tomography (HRCT) and chest X-rays will be used to evaluate changes in lung structure, including bronchiectasis severity and cavitary lesions. Presence and size of cavities will be measured in chest CT, and artificial intelligenced-based scoring systems will be used to measure radiographic severity in chest X-rays.

Other outcomes

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

    Time frame: Baseline, 2 months, 6 months

    Physical function will be assessed using hand-grip strength measurements, a 4-meter walk test, and a sit-to-stand test to evaluate improvements in muscle strength and mobility.

  2. Adverse Events Related to Pulmonary Rehabilitation and Airway Clearance Techniques

    Time frame: Throughout study period (up to 6 months)

    The incidence of adverse events such as fatigue, muscle pain, hemoptysis, and respiratory distress related to pulmonary rehabilitation interventions will be monitored and documented.

  3. Change in body composition: bioimpeance analysis

    Time frame: Baseline, 2 months, 6 months

    Change in body composition will be assesed using the bioimpedance analysis. It provides resistance and reactance measured at different frequency currents, providing estimations of the body fat mass (kg), protein mass (kg), and skeletal muscle mass (kg). Volume of body water (L) and percentage of body fat (%) will be calculated as well.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyung-Jun Kim, MD

CONTACT

[email protected]

+82-31-787-7844

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: NTM-Rehab

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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