NCT06488495 Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
| NCT ID | NCT06488495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Nontuberculous Mycobacterial Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-24 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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 1\) Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1 4. group 1. arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization. 2. arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization. 5\. intervention 1\) 6-week exercise program : one-day hospital-based education, 5-day home-based exercise 6. Participants : 1\) patients with nontuberculous mycobacterial pulmonary disease * 40-80 years old * culture positive within 6months * with respiratory symptoms 7. Outcome measure 1. primary outcome : Oxygen uptake max 2. secondary outcome : 6MWT(six-minute walk test), quality of life, pulmonary function, body composition, inflammatory marker
Eligibility Criteria
Inclusion Criteria: * Adults aged 40-80 diagnosed with NTM pulmonary disease. * Present respiratory symptoms. * Positive NTM culture within the last 6 months. * Voluntary consent to participate. Exclusion Criteria: * Diagnosed with cardiovascular disease. * Recent major hemoptysis. * Musculoskeletal issues preventing free movement. * Unable to read the consent form.