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A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population

Multi-center Clinical Cohort Study on Cardiopulmonary Exercise Tolerance Standards in Chinese Healthy Population

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07108296
Acronym
MCCS-CCPETS
Enrollment
4620
Registered
2025-08-07
Start date
2025-09-01
Completion date
2027-03-30
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen Consumption, Cardiorespiratory Fitness

Keywords

Peak Oxygen Uptake, VO2@AT, Cardiopulmonary Exercise Tolerance, Prediction Model, Healthy Population

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.

Interventions

In this study, the cardiopulmonary exercise testing (CPET) system used breath-by-breath continuous analysis for gas exchange and ventilation variables. The protocol included spirometry with an 8-breath data collection method. The cycle ergometer workload ranged from 10 to 40 W/min using a RAMP protocol. The standard CPET protocol comprised a 3-min rest, 3-min warm-up, 8 - 12 min incremental exercise phase, and 3-min each of active and passive recovery.

Sponsors

Affiliated Hospital of Changchun University of Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peak Oxygen UptakeOn the day of enrollmentWhen 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.

Countries

China

Contacts

Primary ContactHead of Cardiac Rehabilitation Department
Xiopingmeng@126.com+86 131 8088 9430

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026