A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population

Not yet recruiting

• Conditions: Oxygen Consumption; Cardiorespiratory Fitness

• Registration Number: NCT07108296
• Lead Sponsor: Affiliated Hospital of Changchun University of Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-11
• Study Start: 2025-09-01
• Primary Completion: 2026-12-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4620

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Oxygen Uptake	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.

Trial Locations

Locations (15)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Quanzhou First Hospital Affiliated to Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China

Guangdong Provincial People's Hospital Affiliated to Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Jiangbin Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China

The Second Hospital of Harbin Medical University; 🇨🇳 Ha'erbin, Heilongjiang, China

Anyang Regional Hospital of Puyang City, Henan Province; 🇨🇳 Puyang, Henan, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

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