Clinical trial NCT06178913: Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease
Official title: Improving Prognosis and Evaluating Patient Experience Through Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nontuberculous Mycobacteria
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: VO2max
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Secondary outcomes:
measure: The 6-Minute Walk Test
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: 30-Second Sit-to-Stand
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: Short Physical Performance Battery
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: Muscular strength (Handgrip strength in kilograms)
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: COPD Assessment Test
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: the Quality of Life-Bronchiectasis (QOL-B) questionnaire
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: forced vital capacity in percent
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: forced expiratory volume exhaled in the first second in percent
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: a forced expiratory volume in 1 s/forced vital capacity ratio in percent
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: bronchodilator response in percent
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: WBC count per microliter
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: hemoglobin in gram per deciliter
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: Albumin in gram per deciliter
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: CRP in miligram per liter
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: Body fat mass in kilogram
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
measure: skeletal muscle mass in kilogram
timeFrame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
References: