Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorYonsei University

About this trial

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

Qualifiers

Adults aged 40-80 diagnosed with NTM pulmonary disease.

Present respiratory symptoms.

Positive NTM culture within the last 6 months.

Voluntary consent to participate.

Disqualifiers

Diagnosed with cardiovascular disease.

Recent major hemoptysis.

Musculoskeletal issues preventing free movement.

Unable to read the consent form.

Trial design

Treatments tested in this trial

  • Exercise Program
  • Exercise Program

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators