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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults aged 40-80 diagnosed with NTM pulmonary disease.

• Present respiratory symptoms.

• Positive NTM culture within the last 6 months.

• Voluntary consent to participate.

Locations
Other Locations
Republic of Korea
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 50
Treatments
Experimental: Immediate Intervention Group
Participants receive the exercise intervention immediately after randomization
Other: Delayed Intervention Group
Participants receive the exercise intervention immediately after enrollment.
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov