A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease (NTM-Exercise)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- VO2max, maximal oxygen consumption
研究概览
简要总结
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
- Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1 4. group
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arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization.
-
arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization.
-
intervention
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6-week exercise program : one-day hospital-based education, 5-day home-based exercise 6. Participants :
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patients with nontuberculous mycobacterial pulmonary disease
- 40-80 years old
- culture positive within 6months
- with respiratory symptoms 7. Outcome measure
- primary outcome : Oxygen uptake max
- secondary outcome : 6MWT(six-minute walk test), quality of life, pulmonary function, body composition, inflammatory marker
详细描述
Background and Theoretical Basis
- Necessity of Exercise Intervention in Patients with Nontuberculous Mycobacterial Pulmonary Disease NTM (Nontuberculous Mycobacteria) includes all mycobacterial species except for tuberculosis and leprosy bacteria. It is commonly found in water and soil, and the lungs are the most frequent infection site. NTM pulmonary disease is increasing globally and in Korea, where its incidence has risen almost fivefold from 11.4 per 100,000 in 2010 to 56.7 per 100,000 in 2021, surpassing the incidence of tuberculosis (52.1 per 100,000) in 2021.
Economic Impact: Direct medical expenditures related to NTM pulmonary disease in Korea rapidly increased to 20.9 billion KRW in 2021, a 5.8-fold increase compared to 2010. Studies in Canada have shown that the average annual medical cost per NTM patient is $11,541, with higher costs associated with inpatient care prior to death. Reducing hospital admissions through improved prognosis via exercise interventions can be economically beneficial.
Demographic Considerations: The incidence and mortality of NTM pulmonary disease are higher in those over 65 years old, with the prevalence rate being significantly higher in this age group (163.1 per 100,000 in 2021). With Korea's rapidly aging population, the prevalence and associated medical costs of NTM pulmonary disease are expected to increase.
Clinical Considerations: NTM pulmonary disease has a long treatment period with frequent treatment failures and relapses. There is a need for adjunctive therapies beyond pharmacological treatment to improve patient prognosis. Studies have shown a correlation between muscle deterioration measured indirectly by CT and increased mortality in NTM patients, suggesting that exercise interventions to improve muscle quality could enhance patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40-80 diagnosed with NTM pulmonary disease.
- •Present respiratory symptoms.
- •Positive NTM culture within the last 6 months.
- •Voluntary consent to participate.
排除标准
- •Diagnosed with cardiovascular disease.
- •Recent major hemoptysis.
- •Musculoskeletal issues preventing free movement.
- •Unable to read the consent form.
结局指标
主要结局
VO2max, maximal oxygen consumption
时间窗: Immediate intervention group : 1) before exercise program (baseline) 2) after 6-week exerrcise program 3) after 6 month of exercise program
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.
次要结局
- Body composition and handgrip strength(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))
- physical function(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))
- Quality of Life(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))
- Pulmonary Function(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))
- Biochemical inflammatory marker(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))