Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Study Overview
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Brief Summary
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The study goal is to develop exercise intervention methods to improve the prognosis and quality of life of patients with non-tuberculous mycobacterial lung disease and to confirm the effectiveness of exercise intervention. This prospective study is scheduled to be conducted as a pre-post single-arm feasibility trial, targeting a total of 50 subjects.

Detailed Description
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After confirming the intention to participate in the study for patients with non-tuberculous mycobacterial lung disease who meet the selection criteria, basic personal information and clinical history information are collected. When three people are recruited, they are organized into one group and begin a four-week exercise program. A total of 17 groups will be recruited and 50 people will be registered, and within 1 week before and after the start of the exercise program, VO2 max, physical function (6MWT, 30s sit to stand, SPPB, Handgrip strength), Baseline PFT, Laboratory test, Quality of life test (QOL) -B, CAT) is performed. Once a week for 4 weeks, full-body strength training and aerobic exercise are performed for 60 minutes with an exercise expert (supervised exercise), and the remaining 6 days a week are home-based exercises, in which the subject exercises independently at home. Write it down in participants exercise diary. VO2 max, physical function (6MWT, 30s sit to stand, SPPB, handgrip strength), PFT, laboratory test, and quality of life test (QOL-B, CAT) are conducted again within one week before and after the exercise intervention is completed.

Official Title
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Improving Prognosis and Evaluating Patient Experience Through Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Conditions
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Nontuberculous Mycobacteria

Intervention / Treatment
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* Other: Exercise intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 19 to 80 years diagnosed with non-tuberculous mycobacterial lung disease according to the ATS/IDSA guideline, Patients with respiratory symptoms (cough, phlegm, difficulty breathing, etc.) at the time of selection, Patients who understand the purpose of the clinical study and voluntarily agree to participate in this clinical study Exclusion Criteria: Patients diagnosed with cardiovascular disease (Angina, HFrEF, arrhythmia, history of heart valve surgery, etc.), Patients who have had massive hemoptysis within the last 3 months, Patients who have difficulty moving freely due to musculoskeletal problems (osteoarthritis, intervertebral disc herniation, spinal stenosis, etc.), Patients who cannot read the consent form (e.g. illiterate, foreigner, etc.)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br> | Other: Exercise intervention<br>* The exercise intervention method is a circuit training method that combines strength training and aerobic exercise forms and consists of a total of 12 movements. Performing movements 1 to 12 in order is 1 set. After completing the set, when the heart rate returns to the plateau (less than 59% of maximum heart rate), proceed to the next set, for a total of 3 sets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max | The patient wears a mask that transmits inhalation and exhalation to a gas analyzer on the treadmill and a heart rate monitor that measures heart rate. The treadmill gradually increases the incline and increases the speed. When the patient runs as far as they can run and raises their hand to show the measurer, the patient's VO2max is measured by measuring the maximum amount of oxygen that can be taken in and heart rate. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 6-Minute Walk Test | The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| 30-Second Sit-to-Stand | The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| Short Physical Performance Battery | The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| Muscular strength (Handgrip strength in kilograms) | The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| COPD Assessment Test | The COPD Assessment Test and the Quality of Life-Bronchiectasis (QOL-B) questionnaire are used for evaluating the quality of life in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| the Quality of Life-Bronchiectasis (QOL-B) questionnaire | The COPD Assessment Test and the Quality of Life-Bronchiectasis (QOL-B) questionnaire are used for evaluating the quality of life in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| forced vital capacity in percent | Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| forced expiratory volume exhaled in the first second in percent | Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| a forced expiratory volume in 1 s/forced vital capacity ratio in percent | Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| bronchodilator response in percent | Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| WBC count per microliter | WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| hemoglobin in gram per deciliter | WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| Albumin in gram per deciliter | WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| CRP in miligram per liter | WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| Body fat mass in kilogram | Body fat mass in kilograms and skeletal muscle mass in kilograms are used to assess the amount of fat and muscle in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention | 
| skeletal muscle mass in kilogram | Body fat mass in kilograms and skeletal muscle mass in kilograms are used to assess the amount of fat and muscle in our study participants. | within the first 1 week (plus or minus 1 week) after the end of exercise intervention |