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NCT Number: NCT07108296

A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiopulmonary Exercise Testing (CPET)

Other

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.

Primary outcomes

  1. Peak Oxygen Uptake

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Head of Cardiac Rehabilitation Department

CONTACT

[email protected]

+86 131 8088 9430

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Changchun University of Chinese Medicine

Other

Registry information

Official study title

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

Acronym: MCCS-CCPETS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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