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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Exercise Program
BehavioralThe exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.
Exercise Program
BehavioralThe exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Immediate Intervention GroupExperimental treatment 1 intervention
Group B: Delayed Intervention GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
VO2max, maximal oxygen consumption
VO2max will be measured in baseline, after 6-week exercise program in the intervetion arm and baseline, before exercise program, and after 6-week exercise program in the control arm. The difference of VO2 max between the group will be assessed.
Time frame
Immediate intervention group : 1) before exercise program (baseline) 2) after 6-week exerrcise program 3) after 6 month of exercise programSecondary outcomes
1
physical function
6min walk test will be measured in both intervention arm and control arm (delayed intervention group).
Time frame
Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)2
physical function
6min walk test will be measured in both intervention arm and control arm (delayed intervention group).
Time frame
Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)3
physical function
30second sit to stand will be measured in both intervention arm and control arm (delayed intervention group).
Time frame
Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)4
physical function
30second sit to stand will be measured in both intervention arm and control arm (delayed intervention group).
Time frame
Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)Sponsors and contacts
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Source ClinicalTrials.gov