NCT06178913已完成不适用
Improving Prognosis and Evaluating Patient Experience Through Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- VO2max
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
VO2max
时间窗: 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.
次要结局
- Muscular strength (Handgrip strength in kilograms)(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(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- hemoglobin in gram per deciliter(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- bronchodilator response in percent(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- 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(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- Short Physical Performance Battery(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- WBC count per microliter(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- COPD Assessment Test(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- the Quality of Life-Bronchiectasis (QOL-B) questionnaire(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- forced vital capacity in percent(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- Body fat mass in kilogram(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(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- CRP in miligram per liter(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- skeletal muscle mass in kilogram(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
- Albumin in gram per deciliter(within the first 1 week (plus or minus 1 week) after the end of exercise intervention)
研究者
研究点 (2)
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