Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-03
Brief Title:
Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Randomized Controlled Trial on Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease NTM-Exercise
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1objective 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 11 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 6MWTsix-minute walk test quality of life pulmonary function body composition inflammatory marker
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 11 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 6MWTsix-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 114 per 100000 in 2010 to 567 per 100000 in 2021 surpassing the incidence of tuberculosis 521 per 100000 in 2021
Economic Impact Direct medical expenditures related to NTM pulmonary disease in Korea rapidly increased to 209 billion KRW in 2021 a 58-fold increase compared to 2010 Studies in Canada have shown that the average annual medical cost per NTM patient is 11541 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 1631 per 100000 in 2021 With Koreas 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 11
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 patients 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 01 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 patients 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
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 114 per 100000 in 2010 to 567 per 100000 in 2021 surpassing the incidence of tuberculosis 521 per 100000 in 2021
Economic Impact Direct medical expenditures related to NTM pulmonary disease in Korea rapidly increased to 209 billion KRW in 2021 a 58-fold increase compared to 2010 Studies in Canada have shown that the average annual medical cost per NTM patient is 11541 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 1631 per 100000 in 2021 With Koreas 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 11
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 patients 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 01 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None