Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
- Conditions
- Nontuberculous Mycobacterial Pulmonary Disease
- Interventions
- Behavioral: Exercise Program
- Registration Number
- NCT06488495
- Lead Sponsor
- Yonsei University
- Brief 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
- Detailed Description
Background and Theoretical Basis
1. 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.
Conclusion: Developing an exercise intervention program as an adjunctive therapy may contribute to improving prognosis and quality of life for NTM pulmonary disease patients.
2. Recent Research Trends
Existing Research: There are few studies analyzing the effects of exercise interventions in NTM pulmonary disease patients. Two small-scale studies have been conducted on inpatient exercise interventions and chest physical therapy (using positive expiratory pressure devices or cough training). However, there is no large-scale study on outpatient exercise interventions.
Research Gaps: There is a lack of descriptive epidemiological studies on physical activity levels or muscle strength in NTM pulmonary disease patients, which are essential for setting appropriate exercise intervention goals. Existing studies on conditions frequently associated with NTM pulmonary disease, such as bronchiectasis or chronic obstructive pulmonary disease (COPD), have shown that exercise interventions can improve exercise capacity and quality of life.
Conclusion: Given the positive outcomes of exercise interventions in related conditions, further research on the effects of exercise interventions in NTM pulmonary disease patients is warranted.
4. Research Design
(1) Study Design
1. design
1) Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1
2. 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.
3. intervention
1. 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period
4. Participants :
1. Incluison patients with nontuberculous mycobacterial pulmonary disease - 40-80 years old
* culture positive within 6months
* with respiratory symptoms
2. exclusion Patients with severe comorbid conditions, recent surgery, or those unable to participate in exercise programs
5. Procedure
* Baseline Assessment: All participants will undergo initial assessments, including medical history, physical examination, 6MWT, QOL, body composition, handgrip, and pulmonary function tests.
* Randomization: Participants will be randomly assigned to either the intervention group (immediate exercise group) or the control group (delayed exercise group) stratified by BACES score (low BACES (0/1) vs moderate to severe BACES (2-5))
* intervention : 6-week exercise program : one-day hospital-based education, 5-day home-based exercise A structured exercise regimen tailored to each patient's physical capacity, including aerobic, resistance, and flexibility training, conducted over a 6-week period
* Follow-up: Assessments will be repeated after 6-week program and 6 months later to evaluate the impact of the exercise intervention in the intervention group (immediate exercise program).
Assessments will be repeated after 6-week baseline examination, before exercise program and 6 months later to evaluate the impact of the exercise intervention in the control group (delayed exercise group)
Data Analysis: Statistical analyses will be performed to compare the outcomes between the intervention and control groups.
5. Ethical Considerations
Informed Consent: All participants will provide written informed consent before participation.
Ethical Approval: The study protocol was reviewed and approved by the institutional review board (IRB).
6. Outcome measure
1. primary outcome : VO2 max
2. secondary outcome : 6MWT, quality of life, pulmonary function, body composition, inflammatory marker
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Adults aged 40-80 diagnosed with NTM pulmonary disease.
- Present respiratory symptoms.
- Positive NTM culture within the last 6 months.
- Voluntary consent to participate.
- Diagnosed with cardiovascular disease.
- Recent major hemoptysis.
- Musculoskeletal issues preventing free movement.
- Unable to read the consent form.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Intervention Group Exercise Program Participants receive the exercise intervention immediately after randomization Delayed Intervention Group Exercise Program Participants receive the exercise intervention immediately after enrollment.
- Primary Outcome Measures
Name Time Method VO2max, maximal oxygen consumption 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.
- Secondary Outcome Measures
Name Time Method 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) FEV1(forced expiratory
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) global physical activity Questionnaire (GPAQ) : According to the GPAQ analysis guidelines, the metabolic equivalent of task (MET) min per week after assigning MET values (four METs for moderate intensity and eight METs for vigorous intensity) to incorporate the intensity of PA will be calculated. The score of less than 600 classifies the subject as inactive; a score of 600 or more classifies the subject as active.
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) Body composition and handgrip strength be measured in both intervention arm and control arm(delayed intervention group).
Handgrip strength be measured in both intervention arm and control arm(delayed intervention group.
Handgrip strength will be measured using Digital Grip Dynamometer TKK5401. Based on the criteria suggested by the Asian Working Group for Sarcopenia, handgrip strength was categorized into two groups: low handgrip strength, \< 28 kg for male and \< 18 kg for female; and normal handgrip strength, ≥ 28 kg for male and ≥ 18 kg for femaleBiochemical 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) ESR(erythrocyte)
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) Hospital anxiety and depression scale (HDAS) : The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The scale distinguishes between mild symptoms (≥8) and severe symptoms (≥11) of depression or anxiety.
Trial Locations
- Locations (1)
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of