Actively Recruiting
A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease (NTM-Exercise)
Led by Yonsei University ยท Updated on 2026-04-03
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of an exercise intervention program for patients with nontuberculous mycobacterial pulmonary disease (NTM-PD), a chronic lung infection that often affects people with structural lung diseases like COPD and bronchiectasis, as well as those without such conditions. The prevalence of NTM-PD is rising globally, posing public health concerns due to environmental exposure and chronic disease challenges. Pulmonary rehabilitation is important for chronic respiratory diseases, but data on exercise benefits for NTM-PD patients are limited. The study is a prospective, single-center, randomized, open-label trial with two groups. One group begins a six-week exercise program immediately after randomization, while the other starts the same program after a six-week delay. The program includes one day of hospital-based education and five days of home-based exercise each week, with exercises tailored to each patient's capacity, including aerobic, resistance, and flexibility training. Participants aged 40 to 80 with confirmed NTM-PD and respiratory symptoms will undergo baseline assessments including medical history, physical exams, six-minute walk test, quality of life questionnaires, body composition, handgrip strength, and lung function tests. These evaluations will be repeated after the exercise program and six months later to assess effects on maximal oxygen uptake and other health measures. Safety and adherence will be monitored throughout the study, which is sponsored by Yonsei University and scheduled through April 2027.
CONDITIONS
Brief Title
Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 80 diagnosed with nontuberculous mycobacterial pulmonary disease
- Presence of respiratory symptoms
- Positive NTM culture within the last 6 months
- Voluntary consent to participate
You will not qualify if you...
- Diagnosis of cardiovascular disease
- Recent major hemoptysis (serious lung bleeding)
- Musculoskeletal problems preventing free movement
- Unable to read or understand the consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo initial assessments including medical history, physical examination, and tests to measure physical function, quality of life, body composition, and pulmonary function.
1 visit (in-person)
Duration - 6 weeks
Participants engage in a 6-week exercise program involving one day of hospital-based education and daily home-based aerobic, resistance, and flexibility training tailored to their capacity.
1 hospital-based education visit and daily home-based exercises
Duration - 1 day
Participants complete follow-up assessments to evaluate physical function, quality of life, and other health measures immediately after the exercise program ends.
1 visit (in-person)
Duration - 6 months
Participants return for a long-term evaluation 6 months after completing the exercise program to assess sustained effects on physical function and health.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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