Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorSeoul National University Bundang Hospital
About this trial
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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 population
This study will enroll adult patients (≥20 years old) diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD) based on the 2020 ATS guidelines. Participants will be recruited from outpatient pulmonary clinics at study sites. 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: NTM-PD Pulmonary Rehabilitation Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 2 months, 6 months2
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.
Time frame
Baseline, 2 months, 6 months3
6MWT
6 minute walk test distance in meters
Time frame
Baseline, 2 months, 6 monthsSecondary outcomes
1
Change in Questionnaire-Bronchiectasis (QOL-B) from Baseline to 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.
Time frame
Baseline, 2 months, 6 months2
Change in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) from Baseline to 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.
Time frame
Baseline, 2 months, 6 months3
Severity of radiographic findings
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.
Time frame
Baseline, 2 months, 6 monthsOther outcomes
1
Change in Physical Function (Grip Strength, 4-Meter Walk Test, Sit-to-Stand Test) from Baseline to 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.
Time frame
Baseline, 2 months, 6 months2
Adverse Events Related to Pulmonary Rehabilitation and Airway Clearance Techniques
The incidence of adverse events such as fatigue, muscle pain, hemoptysis, and respiratory distress related to pulmonary rehabilitation interventions will be monitored and documented.
Time frame
Throughout study period (up to 6 months)3
Change in body composition: bioimpeance analysis
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.
Time frame
Baseline, 2 months, 6 monthsSponsors and contacts
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Source ClinicalTrials.gov