RecruitingNot ApplicableNCT06488495

Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease

A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease (NTM-Exercise)


Sponsor

Yonsei University

Enrollment

50 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria4

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

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Interventions

BEHAVIORALExercise Program

The exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.

BEHAVIORALExercise Program

The exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.


Locations(1)

Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System

Seoul, South Korea

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NCT06488495


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