Multi-center Clinical Cohort Study on Cardiopulmonary Exercise Tolerance Standards in Chinese Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,620
- 试验地点
- 15
- 主要终点
- Peak Oxygen Uptake
研究概览
简要总结
This project intends to conduct a large-sample, prospective, multicenter clinical cohort study in healthy populations. By utilizing a digital cardiopulmonary rehabilitation clinical data research platform, The investigators aim to achieve automated, standardized, and uniform collection, analysis, and AI modeling of large-scale cardiopulmonary exercise testing (CPET) data. The ultimate goals are:
To establish reference standards for cardiopulmonary exercise capacity in the Chinese healthy population.
To develop machine learning-based predictive models for key CPET variables (e.g., peak VO₂) tailored to Chinese demographics.
To compare performance differences between domestically produced and imported CPET devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Detailed medical history taken, with no symptoms of discomfort reported
- •Good physical condition, with no history of severe chronic diseases
- •No history of long - term medication use
- •Willing to undergo cardiopulmonary exercise testing, with no ST - T segment changes observed during the test
- •Age: 18 - 65 years old
- •BMI: 18.5 - 28kg/m²
- •No smoking history or quit smoking for ≥5 years
- •Physical examination reports within 2 years show no significant abnormalities.
排除标准
- •Pre - test resting blood pressure ≥160/100 mmHg (1 mmHg=0.133 kPa)
- •Chronic cardiovascular diseases, such as heart failure, coronary atherosclerotic heart disease, hypertension, congenital heart disease, cardiomyopathy, and severe arrhythmias
- •Respiratory diseases, such as chronic obstructive pulmonary disease, asthma, pulmonary artery hypertension, bronchiectasis, and respiratory failure
- •Digestive system diseases, such as peptic ulcer, gastrointestinal bleeding, hepatitis, liver cirrhosis, ulcerative colitis, Crohn's disease, chronic pancreatitis, and chronic cholecystitis
- •Endocrine system diseases, such as hyperthyroidism, hypothyroidism, diabetes, and other diseases with clear hormone abnormalities
- •Acute or chronic kidney diseases, blood system diseases, malignant tumors, and bone and joint diseases that affect activity
- •No history of acute infection within 2 weeks
- •Unable to cooperate with the examination
- •Contraindications to cardiopulmonary exercise testing: acute myocardial infarction
结局指标
主要结局
Peak Oxygen Uptake
时间窗: On the day of enrollment
When measuring the peak oxygen uptake of healthy people with a cycle ergometer, first ensure participants are healthy and have signed consent forms. Prepare the cycle ergometer and other equipment, adjusting them to a suitable position. After a 3 - minute warm - up, start the incremental loading test, which lasts 8 - 12 minutes, until termination criteria are met. Record the data, calculate the peak oxygen uptake, and assess the cardiopulmonary function.
次要结局
未报告次要终点
研究者
Xiaoping Meng
Head of Cardiac Rehabilitation Department
Affiliated Hospital of Changchun University of Chinese Medicine