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NCT Number: NCT06178913

Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

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.

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Key information

Conditions

Nontuberculous Mycobacteria

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Exercise intervention

Other

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.

Primary outcomes

  1. VO2max

    Time frame: 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 outcomes

  1. The 6-Minute Walk Test

    Time frame: 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.

  2. 30-Second Sit-to-Stand

    Time frame: 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.

  3. Short Physical Performance Battery

    Time frame: 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.

  4. Muscular strength (Handgrip strength in kilograms)

    Time frame: 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.

  5. COPD Assessment Test

    Time frame: 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.

  6. the Quality of Life-Bronchiectasis (QOL-B) questionnaire

    Time frame: 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.

  7. forced vital capacity in percent

    Time frame: 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.

  8. forced expiratory volume exhaled in the first second in percent

    Time frame: 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.

  9. a forced expiratory volume in 1 s/forced vital capacity ratio in percent

    Time frame: 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.

  10. bronchodilator response in percent

    Time frame: 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.

  11. WBC count per microliter

    Time frame: 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.

  12. hemoglobin in gram per deciliter

    Time frame: 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.

  13. Albumin in gram per deciliter

    Time frame: 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.

  14. CRP in miligram per liter

    Time frame: 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.

  15. Body fat mass in kilogram

    Time frame: 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.

  16. skeletal muscle mass in kilogram

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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