Nontuberculous Mycobacterial Pulmonary DiseaseNCT06488495
Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
A study testing Exercise Program in people with Nontuberculous Mycobacterial Pulmonary Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
1.objective Evaluation of effectiveness and safety of exercise intervention program for patients with non-tuberculous mycobacterial pulmonary disease 2. background Nontuberculous mycobacterial pulmonary disease (NTM-PD) is a chronic respiratory infection that generally affects individuals with structural lung… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Nontuberculous Mycobacterial Pulmonary Disease
- What is being tested?
- Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-80 diagnosed with NTM pulmonary disease.
- Present respiratory symptoms.
- Positive NTM culture within the last 6 months.
- Voluntary consent to participate.
Who cannot join
- Diagnosed with cardiovascular disease.
- Recent major hemoptysis.
- Musculoskeletal issues preventing free movement.
- Unable to read the consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul
Young Ae Kang, +82-2-2228-1986, mdkang@yuhs.ac
About this study
Official title: A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease (NTM-Exercise)
1.objective Evaluation of effectiveness and safety of exercise intervention program for patients with non-tuberculous mycobacterial pulmonary disease 2. background Nontuberculous mycobacterial pulmonary disease (NTM-PD) is a chronic respiratory infection that generally affects individuals with structural lung diseases, such as chronic obstructive pulmonary disease (COPD) and bronchiectasis and without structural lung disease. The prevalence of NTM-PD is increasing worldwide , which has caused public health concerns because of environmental exposure to nontuberculous mycobacteria (NTM) and chronic intractable diseases.
Pulmonary rehabilitation is essential to the non-pharmacological treatment of chronic respiratory diseases. Positive effects of exercise training have been demonstrated in COPD and bronchiectasis. However, there are limited data on the effectiveness and safety of exercise program for patients with non-tuberculous mycobacterial pulmonary disease 3. design
Read more
- Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1 4. group
- arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization.
- arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization.
- intervention
- 6-week exercise program : one-day hospital-based education, 5-day home-based exercise 6. Participants :
- patients with nontuberculous mycobacterial pulmonary disease
- 40-80 years old
- culture positive within 6months
- with respiratory symptoms 7. Outcome measure
- primary outcome : Oxygen uptake max
- secondary outcome : 6MWT(six-minute walk test), quality of life, pulmonary function, body composition, inflammatory marker
Read the detailed description
Background and Theoretical Basis
- Necessity of Exercise Intervention in Patients with Nontuberculous Mycobacterial Pulmonary Disease NTM (Nontuberculous Mycobacteria) includes all mycobacterial species except for tuberculosis and leprosy bacteria. It is commonly found in water and soil, and the lungs are the most frequent infection site. NTM pulmonary disease is increasing globally and in Korea, where its incidence has risen almost fivefold from 11.4 per 100,000 in 2010 to 56.7 per 100,000 in 2021, surpassing the incidence of tuberculosis (52.1 per 100,000) in 2021. Economic Impact: Direct medical expenditures related to NTM pulmonary disease in Korea rapidly increased to 20.9 billion KRW in 2021, a 5.8-fold increase compared to 2010. Studies in Canada have shown that the average annual medical cost per NTM patient is $11,541, with higher costs associated with inpatient care prior to death. Reducing hospital admissions through improved prognosis via exercise interventions can be economically beneficial. Demographic Considerations: The incidence and mortality of NTM pulmonary disease are higher in those over 65 years old, with the prevalence rate being significantly higher in this age group (163.1 per 100,000 in 2021). With Korea's rapidly aging population, the prevalence and associated medical costs of NTM pulmonary disease are expected to increase. Clinical Considerations: NTM pulmonary disease has a long treatment period with frequent treatment failures and relapses. There is a need for adjunctive therapies beyond pharmacological treatment to improve patient prognosis. Studies have shown a correlation between muscle deterioration measured indirectly by CT and increased mortality in NTM patients, suggesting that exercise interventions to improve muscle quality could enhance patient outcomes. Conclusion: Developing an exercise intervention program as an adjunctive therapy may contribute to improving prognosis and quality of life for NTM pulmonary disease patients.
- Recent Research Trends
Existing Research: There are few studies analyzing the effects of exercise interventions in NTM pulmonary disease patients. Two small-scale studies have been conducted on inpatient exercise interventions and chest physical therapy (using positive expiratory pressure devices or cough training). However, there is no large-scale study on outpatient exercise interventions.
Research Gaps: There is a lack of descriptive epidemiological studies on physical activity levels or muscle strength in NTM pulmonary disease patients, which are essential for setting appropriate exercise intervention goals. Existing studies on conditions frequently associated with NTM pulmonary disease, such as bronchiectasis or chronic obstructive pulmonary disease (COPD), have shown that exercise interventions can improve exercise capacity and quality of life.
Conclusion: Given the positive outcomes of exercise interventions in related conditions, further research on the effects of exercise interventions in NTM pulmonary disease patients is warranted.
- Research Design (1) Study Design
- design
- Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1
- group
- arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization.
- arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization.
- intervention
- 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period
- Participants :
- Incluison patients with nontuberculous mycobacterial pulmonary disease - 40-80 years old
- culture positive within 6months
- with respiratory symptoms
- exclusion Patients with severe comorbid conditions, recent surgery, or those unable to participate in exercise programs
- Procedure
- Baseline Assessment: All participants will undergo initial assessments, including medical history, physical examination, 6MWT, QOL, body composition, handgrip, and pulmonary function tests.
- Randomization: Participants will be randomly assigned to either the intervention group (immediate exercise group) or the control group (delayed exercise group) stratified by BACES score (low BACES (0/1) vs moderate to severe BACES (2-5))
- intervention : 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period
- Follow-up: Assessments will be repeated after 6-week program and 6 months later to evaluate the impact of the exercise intervention in the intervention group (immediate exercise program).
Assessments will be repeated after 6-week baseline examination, before exercise program and 6 months later to evaluate the impact of the exercise intervention in the control group (delayed exercise group)
Data Analysis: Statistical analyses will be performed to compare the outcomes between the intervention and control groups.
- Ethical Considerations
Informed Consent: All participants will provide written informed consent before participation.
Ethical Approval: The study protocol was reviewed and approved by the institutional review board (IRB).
- Outcome measure
- primary outcome : VO2 max
- secondary outcome : 6MWT, quality of life, pulmonary function, body composition, inflammatory marker
- Being tested
- Exercise Program
- Keywords
- NTM, Pulmonary Disease, Exercise
- Medical subject headings
- Lung Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
The exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.
Exercise ProgramBehavioural
The exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | Participants receive the exercise intervention immediately after randomization Receives: Behavioral: Exercise Program |
| Delayed Intervention Group | Other | Participants receive the exercise intervention immediately after enrollment. Receives: Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max, maximal oxygen consumption
VO2max will be measured in baseline, after 6-week exercise program in the intervetion arm and baseline, before exercise program, and after 6-week exercise program in the control arm. The difference of VO2 max between the group will be assessed.
Measured: Immediate intervention group : 1) before exercise program (baseline) 2) after 6-week exerrcise program 3) after 6 month of exercise program
Secondary outcomes (32)
physical function
6min walk test will be measured in both intervention arm and control arm (delayed intervention group).
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
6min walk test will be measured in both intervention arm and control arm (delayed intervention group).
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
physical function
30second sit to stand will be measured in both intervention arm and control arm (delayed intervention group).
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
30second sit to stand will be measured in both intervention arm and control arm (delayed intervention group).
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
physical function
Short physical performance battery (SPPB) will be measured in both intervention arm and control arm (delayed intervention group).
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
Short physical performance battery (SPPB) will be measured in both intervention arm and control arm (delayed intervention group).
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
physical function
global physical activity Questionnaire (GPAQ) : According to the GPAQ analysis guidelines, the metabolic equivalent of task (MET) min per week after assigning MET values (four METs for moderate intensity and eight METs for vigorous intensity) to incorporate the intensity of PA will be calculated. The score of less than 600 classifies the subject as inactive; a score of 600 or more classifies the subject as active.
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
global physical activity Questionnaire (GPAQ) : According to the GPAQ analysis guidelines, the metabolic equivalent of task (MET) min per week after assigning MET values (four METs for moderate intensity and eight METs for vigorous intensity) to incorporate the intensity of PA will be calculated. The score of less than 600 classifies the subject as inactive; a score of 600 or more classifies the subject as active.
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
Body composition will be measured by bioimpedance analysis using an InBody 770 device (Biospace, Seoul, Republic of Korea). Skeletal muscle mass, appendicular skeletal muscle mass, fat mass, fat free mass will be measured. Sarcopenia was diagnosed when patients also exhibited low appendicular skeletal muscle mass divided by height squared (<7.0 kg/m2 for males and <5.7 kg/m2 for females). Adipopenia was defined when the fat mass index (FMI) was below the lower limit of the normal range (<3 kg/m2 for males and <5 kg/m2 for females), based on a study examining normal FMI in a Korean population
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
Body composition will be measured by bioimpedance analysis using an InBody 770 device (Biospace, Seoul, Republic of Korea). Skeletal muscle mass, appendicular skeletal muscle mass, fat mass, fat free mass will be measured. Sarcopenia was diagnosed when patients also exhibited low appendicular skeletal muscle mass divided by height squared (<7.0 kg/m2 for males and <5.7 kg/m2 for females). Adipopenia was defined when the fat mass index (FMI) was below the lower limit of the normal range (<3 kg/m2 for males and <5 kg/m2 for females), based on a study examining normal FMI in a Korean population
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
COPD assessment test (CAT) :The score will range from 0 to 40. Higher scores indicate COPD has a greater impact on the QOL.
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
COPD assessment test (CAT) The score will range from 0 to 40. Higher scores indicate COPD has a greater impact on the QOL.
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
Quality of Life Questionnaire-Bronchiectasis (QOL-B) :Score will range from 0 to 100. Higher scores indicate COPD has a greater impact on the QOL. Higher scores indicate high QOL.
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
Quality of Life Questionnaire-Bronchiectasis (QOL-B) : Score will range from 0 to 100. Higher scores indicate COPD has a greater impact on the QOL. Higher scores indicate high QOL.
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
Hospital anxiety and depression scale (HDAS) :The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The scale distinguishes between mild symptoms (≥8) and severe symptoms (≥11) of depression or anxiety.
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
Hospital anxiety and depression scale (HDAS) : The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The scale distinguishes between mild symptoms (≥8) and severe symptoms (≥11) of depression or anxiety.
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
PFT(pulmonary function test)
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
PFT(pulmonary function test)
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
FVC(forced vital capacity)
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
FVC(forced vital capacity)
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
FEV1(forced expiratory
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
FEV1(forced expiratory
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
CBC(complete blood count)
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
CBC(complete blood count)
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Albumin
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Albumin
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
CRP(C reactive protein)
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
CRP(C reactive protein)
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
ESR(erythrocyte)
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
ESR(erythrocyte)
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Body composition and handgrip strength
Body composition and handgrip strength be measured in both intervention arm and control arm(delayed intervention group).
Handgrip strength be measured in both intervention arm and control arm(delayed intervention group.
Handgrip strength will be measured using Digital Grip Dynamometer TKK5401. Based on the criteria suggested by the Asian Working Group for Sarcopenia, handgrip strength was categorized into two groups: low handgrip strength, < 28 kg for male and < 18 kg for female; and normal handgrip strength, ≥ 28 kg for male and ≥ 18 kg for female
Measured: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Body composition and handgrip strength
Body composition and handgrip strength be measured in both intervention arm and control arm(delayed intervention group).
Handgrip strength be measured in both intervention arm and control arm(delayed intervention group.
Handgrip strength will be measured using Digital Grip Dynamometer TKK5401. Based on the criteria suggested by the Asian Working Group for Sarcopenia, handgrip strength was categorized into two groups: low handgrip strength, < 28 kg for male and < 18 kg for female; and normal handgrip strength, ≥ 28 kg for male and ≥ 18 kg for female
Measured: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start24 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nontuberculous Mycobacterial Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488495
- Sponsor's protocol ID
- 4-2024-0147
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available upon reasonable request, subject to approval by the Severance Hospital Institutional Review Board
Publications
Kim M, Park Y, Park DH, Kim C, Kim EC, Kim N, Jung I, Jeon JY, Kang YA. Exercise programme in patients with non-tuberculous mycobacterial pulmonary disease (NTM-Exercise): protocol of a randomised controlled trial. BMJ Open. 2026 Jul 15;16(7):e113136. doi: 10.1136/bmjopen-2025-113136.
PubMed 42463200
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease (NTM-Exercise)
- ClinicalTrials.gov ID
- NCT06488495
- Acronym / sponsor ID
- 4-2024-0147
- Keywords
- NTM, Pulmonary Disease, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
1.objective Evaluation of effectiveness and safety of exercise intervention program for patients with non-tuberculous mycobacterial pulmonary disease 2. background Nontuberculous mycobacterial pulmonary disease (NTM-PD) is a chronic respiratory infection that generally affects individuals with structural lung diseases, such as chronic obstructive pulmonary disease (COPD) and bronchiectasis and without structural lung disease. The prevalence of NTM-PD is increasing worldwide , which has caused public health concerns because of environmental exposure to nontuberculous mycobacteria (NTM) and chronic intractable diseases.
Pulmonary rehabilitation is essential to the non-pharmacological treatment of chronic respiratory diseases. Positive effects of exercise training have been demonstrated in COPD and bronchiectasis. However, there are limited data on the effectiveness and safety of exercise program for patients with non-tuberculous mycobacterial pulmonary disease 3. design
- Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1 4. group
- arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization.
- arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization.
- intervention
- 6-week exercise program : one-day hospital-based education, 5-day home-based exercise 6. Participants :
- patients with nontuberculous mycobacterial pulmonary disease
- 40-80 years old
- culture positive within 6months
- with respiratory symptoms 7. Outcome measure
- primary outcome : Oxygen uptake max
- secondary outcome : 6MWT(six-minute walk test), quality of life, pulmonary function, body composition, inflammatory marker
Detailed description
Background and Theoretical Basis
- Necessity of Exercise Intervention in Patients with Nontuberculous Mycobacterial Pulmonary Disease NTM (Nontuberculous Mycobacteria) includes all mycobacterial species except for tuberculosis and leprosy bacteria. It is commonly found in water and soil, and the lungs are the most frequent infection site. NTM pulmonary disease is increasing globally and in Korea, where its incidence has risen almost fivefold from 11.4 per 100,000 in 2010 to 56.7 per 100,000 in 2021, surpassing the incidence of tuberculosis (52.1 per 100,000) in 2021. Economic Impact: Direct medical expenditures related to NTM pulmonary disease in Korea rapidly increased to 20.9 billion KRW in 2021, a 5.8-fold increase compared to 2010. Studies in Canada have shown that the average annual medical cost per NTM patient is $11,541, with higher costs associated with inpatient care prior to death. Reducing hospital admissions through improved prognosis via exercise interventions can be economically beneficial. Demographic Considerations: The incidence and mortality of NTM pulmonary disease are higher in those over 65 years old, with the prevalence rate being significantly higher in this age group (163.1 per 100,000 in 2021). With Korea's rapidly aging population, the prevalence and associated medical costs of NTM pulmonary disease are expected to increase. Clinical Considerations: NTM pulmonary disease has a long treatment period with frequent treatment failures and relapses. There is a need for adjunctive therapies beyond pharmacological treatment to improve patient prognosis. Studies have shown a correlation between muscle deterioration measured indirectly by CT and increased mortality in NTM patients, suggesting that exercise interventions to improve muscle quality could enhance patient outcomes. Conclusion: Developing an exercise intervention program as an adjunctive therapy may contribute to improving prognosis and quality of life for NTM pulmonary disease patients.
- Recent Research Trends
Existing Research: There are few studies analyzing the effects of exercise interventions in NTM pulmonary disease patients. Two small-scale studies have been conducted on inpatient exercise interventions and chest physical therapy (using positive expiratory pressure devices or cough training). However, there is no large-scale study on outpatient exercise interventions.
Research Gaps: There is a lack of descriptive epidemiological studies on physical activity levels or muscle strength in NTM pulmonary disease patients, which are essential for setting appropriate exercise intervention goals. Existing studies on conditions frequently associated with NTM pulmonary disease, such as bronchiectasis or chronic obstructive pulmonary disease (COPD), have shown that exercise interventions can improve exercise capacity and quality of life.
Conclusion: Given the positive outcomes of exercise interventions in related conditions, further research on the effects of exercise interventions in NTM pulmonary disease patients is warranted.
- Research Design (1) Study Design
- design
- Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1
- group
- arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization.
- arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization.
- intervention
- 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period
- Participants :
- Incluison patients with nontuberculous mycobacterial pulmonary disease - 40-80 years old
- culture positive within 6months
- with respiratory symptoms
- exclusion Patients with severe comorbid conditions, recent surgery, or those unable to participate in exercise programs
- Procedure
- Baseline Assessment: All participants will undergo initial assessments, including medical history, physical examination, 6MWT, QOL, body composition, handgrip, and pulmonary function tests.
- Randomization: Participants will be randomly assigned to either the intervention group (immediate exercise group) or the control group (delayed exercise group) stratified by BACES score (low BACES (0/1) vs moderate to severe BACES (2-5))
- intervention : 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period
- Follow-up: Assessments will be repeated after 6-week program and 6 months later to evaluate the impact of the exercise intervention in the intervention group (immediate exercise program).
Assessments will be repeated after 6-week baseline examination, before exercise program and 6 months later to evaluate the impact of the exercise intervention in the control group (delayed exercise group)
Data Analysis: Statistical analyses will be performed to compare the outcomes between the intervention and control groups.
- Ethical Considerations
Informed Consent: All participants will provide written informed consent before participation.
Ethical Approval: The study protocol was reviewed and approved by the institutional review board (IRB).
- Outcome measure
- primary outcome : VO2 max
- secondary outcome : 6MWT, quality of life, pulmonary function, body composition, inflammatory marker
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Behavioral: Exercise ProgramParticipants receive the exercise intervention immediately after randomization |
| Delayed Intervention Group | Other | Behavioral: Exercise ProgramParticipants receive the exercise intervention immediately after enrollment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 40-80 diagnosed with NTM pulmonary disease.
- Present respiratory symptoms.
- Positive NTM culture within the last 6 months.
- Voluntary consent to participate.
Key exclusion criteria (4 listed)
- Diagnosed with cardiovascular disease.
- Recent major hemoptysis.
- Musculoskeletal issues preventing free movement.
- Unable to read the consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramThe exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises. | Behavioural | Immediate Intervention Group |
| Exercise ProgramThe exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises. | Behavioural | Delayed Intervention Group |
Primary outcome
VO2max, maximal oxygen consumption
Time frame: Immediate intervention group : 1) before exercise program (baseline) 2) after 6-week exerrcise program 3) after 6 month of exercise program
VO2max will be measured in baseline, after 6-week exercise program in the intervetion arm and baseline, before exercise program, and after 6-week exercise program in the control arm. The difference of VO2 max between the group will be assessed.
32 secondary outcomes
physical function
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
physical function
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
physical function
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
physical function
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
physical function
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Quality of Life
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Pulmonary Function
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Biochemical inflammatory marker
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Body composition and handgrip strength
Time frame: Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)
Body composition and handgrip strength
Time frame: Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 42463200Kim M, Park Y, Park DH, Kim C, Kim EC, Kim N, Jung I, Jeon JY, Kang YA. Exercise programme in patients with non-tuberculous mycobacterial pulmonary disease (NTM-Exercise): protocol of a randomised controlled trial. BMJ Open. 2026 Jul 15;16(7):e113136. doi: 10.1136/bmjopen-2025-113136.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available upon reasonable request, subject to approval by the Severance Hospital Institutional Review Board
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Nontuberculous Mycobacterial Pulmonary Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max, maximal oxygen consumption (time frame: Immediate intervention group : 1) before exercise program (baseline) 2) after 6-week exerrcise program 3) after 6 month of exercise program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06488495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.