Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Nontuberculous Mycobacteria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178913
• Other study ID #: 4-2023-0549
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Yonsei University
• Contact: Young Ae Kang
• Phone: +82-2228-1954
• Email: mdkang[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Infections
• Nontuberculous Mycobacteria

Intervention

Other:
• Exercise intervention
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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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