Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Recruiting now · Not applicable

Conditions studied: Nontuberculous Mycobacterial Pulmonary Disease

In brief

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

Key facts

Study ID

NCT06488495

Run by

Yonsei University

People needed

50

Starts

2024-07-24

Expected to finish

2027-04-01

Last updated by the study team

2026-04-03

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 40-80 diagnosed with NTM pulmonary disease.
• Present respiratory symptoms.
• Positive NTM culture within the last 6 months.
• Voluntary consent to participate.

You may not qualify if…

• Diagnosed with cardiovascular disease.
• Recent major hemoptysis.
• Musculoskeletal issues preventing free movement.
• Unable to read the consent form.

Where it is running

• Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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