Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Not Applicable

Completed

• Conditions: Nontuberculous Mycobacteria
• Interventions: Other: Exercise intervention

• Registration Number: NCT06178913
• Lead Sponsor: Yonsei University

Brief Summary

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

1. 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.

2. 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.

3. 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.

4. 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.

Study Timeline

• Study Start: 2023-07-10
• Study First Submitted: 2023-11-22
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-21
• Primary Completion: 2024-01-10
• Study Completion: 2024-02-20
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise intervention	Exercise intervention	-

Primary Outcome Measures

Name	Time	Method
VO2max	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.

Secondary Outcome Measures

Name	Time	Method
Muscular strength (Handgrip strength in kilograms)	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
forced expiratory volume exhaled in the first second in percent	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
hemoglobin in gram per deciliter	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
30-Second Sit-to-Stand	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
bronchodilator response in percent	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
The 6-Minute Walk Test	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
Short Physical Performance Battery	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
WBC count per microliter	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
COPD Assessment Test	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
the Quality of Life-Bronchiectasis (QOL-B) questionnaire	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
forced vital capacity in percent	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
Body fat mass in kilogram	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
a forced expiratory volume in 1 s/forced vital capacity ratio in percent	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
CRP in miligram per liter	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
skeletal muscle mass in kilogram	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.
Albumin in gram per deciliter	within the first 1 week (plus or minus 1 week) after the end of exercise intervention	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.

Trial Locations

Locations (1)

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of