Clinical trial NCT06488495: Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
Official title: A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease (NTM-Exercise)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nontuberculous Mycobacterial Pulmonary Disease
Keywords: NTM
Pulmonary Disease
Exercise
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: VO2max, maximal oxygen consumption
timeFrame: Immediate intervention group : 1) before exercise program (baseline) 2) after 6-week exerrcise program 3) after 6 month of exercise program
Secondary outcomes:
measure: physical function
timeFrame: 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)
measure: physical function
timeFrame: 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)
measure: physical function
timeFrame: 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)
measure: physical function
timeFrame: 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)
measure: physical function
timeFrame: 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)
measure: physical function
timeFrame: 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)
measure: physical function
timeFrame: 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)
measure: physical function
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Quality of Life
timeFrame: 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)
measure: Pulmonary Function
timeFrame: 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)
measure: Pulmonary Function
timeFrame: 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)
measure: Pulmonary Function
timeFrame: 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)
measure: Pulmonary Function
timeFrame: 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)
measure: Pulmonary Function
timeFrame: 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)
measure: Pulmonary Function
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Biochemical inflammatory marker
timeFrame: 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)
measure: Body composition and handgrip strength
timeFrame: 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)
measure: Body composition and handgrip strength
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Study officials:
References: