Clinical Research on the Improvement of Exercise Endurance in Idiopathic Pulmonary Fibrosis by Daoyin Technique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- the 30 - second sit - to - stand test(30s STS)
研究概览
简要总结
This study is based on the previously constructed digital rehabilitation management platform, scientifically evaluating the clinical efficacy of guided technology in improving IPF exercise endurance, and forming high-quality clinical evidence.
详细描述
This study is based on a digital and intelligent rehabilitation management platform. It collects patients' movement data through intelligent motion capture equipment and heart rate, blood oxygen, and other data using fitness trackers, to complete rehabilitation tracking management, real-time assessment, and effect evaluation. Adopting a multi-center,non inferiority, randomized controlled clinical trial design, 236 IPF patients were selected as the research subjects. Based on the guideline-directed treatment, the experimental group received guided techniques, while the control group received conventional comprehensive training. The intervention lasted for 3 months, followed by a 3-month follow-up. The primary outcome measures were 6MWD and 30- second sit-to-stand test, while secondary outcome measures included acute exacerbation, FVC, DLCO, VO2 peak, mMRC score, ATAQ-IPF score, etc. The study elucidated the mechanism of action, scientifically evaluated the impact of guided techniques on IPF endurance, and established a guided technique protocol for IPF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnostic criteria for IPF;
- •Those who can tolerate guided - technique training;
- •Aged between 40 and 85 years old;
- •Those who can independently or with the assistance of family members use devices such as smartphones and computers during home - based training;
- •Those who voluntarily accept treatment and sign the informed consent form.
排除标准
- •Patients in the acute exacerbation phase of IPF.
- •Patients with comorbidities such as chronic obstructive pulmonary disease, lung cancer, active pulmonary tuberculosis, bronchiectasis, pulmonary embolism, and other pulmonary diseases.
- •Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, cardiac function at grade 3 or above, stroke, cerebral hemorrhage, etc.).
- •Patients with severe liver diseases (such as bleeding caused by liver cirrhosis, portal hypertension, and esophagogastric varices) and severe kidney diseases (dialysis, kidney transplantation, etc.).
- •Patients with severe osteoarthropathy or osteoporosis, and those with unstable fractures.
- •Patients with progressive neuromuscular diseases.
- •Patients with unclear consciousness, dementia, and various mental illnesses.
- •Pregnant or lactating women, and patients with a recent pregnancy plan.
- •Patients who have been participating in other clinical trials within 1 month before enrollment.
- •Patients who need long - term use of ventilators and those with unstable vital signs while bedridden.
结局指标
主要结局
the 30 - second sit - to - stand test(30s STS)
时间窗: Change from baseline FVC at week 13 and 26.
30s STS will be used to assess pulmonary function.
6 Six Minute Walk Distance(6MWD)
时间窗: Change from baseline 6MWD at week 13 and 26.
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
次要结局
- The time of the first acute exacerbation(Up to week 26.)
- Frequency of acute exacerbation(Up to week 26.)
- Frequency of acute exacerbations resulting in hospitalization(Up to week 26.)
- Frequency of acute exacerbations resulting in ICU admission(Up to week 26.)
- Forced vital capacity (FVC)(Change from baseline FVC at week 13 and 26.)
- Forced expiratory volume in one second(FEV1)(Change from baseline FEV1 at week 13 and 26.)
- Percent of FEV1#FEV1%#(Change from baseline FEV1% at week 13 and 26.)
- Diffusing Capacity of Carbon Monoxide#DLCO#(Change from baseline DLCO at week 13 and 26.)
- Cardiopulmonary Exercise Testing(CPET)(Change from baseline Peak Oxygen Uptake, Anaerobic Threshold, Breathing Reserve, and ventilatory equivalent for carbon dioxide at week 13 and 26.)
- Blood oxygen saturation(SpO2)(Change from baseline SpO2 at week 13 and 26.)
- Dyspnea(Change from baseline mMRC scores at week 13 and 26.)
- A Tool to Assess Quality of life (ATAQ-IPF)(Change from baseline ATAQ-IPF scores at week 13 and 26.)
- St. George's respiratory questionnaire (SGRQ)(Change from baseline SGRQ scores at week 13 and 26.)
- Clinical symptoms and Signs(Change from baseline clinical symptoms and signs up at week 13 and 26.)
- Imaging findings(Up to week 13, 26.)