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Not yet recruiting NCT07108296

A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population

— Observational Oxygen Consumption Cardiorespiratory Fitness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cardiopulmonary exercise testing (CPET).
Who it may be relevant to
Registry conditions: Oxygen Consumption, Cardiorespiratory Fitness. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other cardiopulmonary exercise testing (CPET)
    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 outcome measures

  • Peak Oxygen Uptake [Time frame: On the day of enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 15 centers
  • Peking Union Medical College Hospital — Beijing
  • Quanzhou First Hospital Affiliated to Fujian Medical University — Quanzhou
  • Guangdong Provincial People's Hospital Affiliated to Southern Medical University — Guangzhou
  • Guangdong Provincial Hospital of Chinese Medicine — Guangzhou
  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region — Nanning
  • Daqing Oilfield General Hospital — Daqing
  • The Second Hospital of Harbin Medical University — Harbin
  • Anyang Regional Hospital of Puyang City, Henan Province — Puyang
  • … and 7 more centers

Publications

  • Strain T, Flaxman S, Guthold R, Semenova E, Cowan M, Riley LM, Bull FC, Stevens GA; Country Data Author Group. National, regional, and global trends in insufficient physical activity among adults from 2000 to 2022: a pooled analysis of 507 population-based surveys with 5.7 million participants. Lancet Glob Health. 2024 Aug;12(8):e1232-e1243. doi: 10.1016/S2214-109X(24)00150-5. Epub 2024 Jun 25. PMID 38942042
  • Weeldreyer NR, De Guzman JC, Paterson C, Allen JD, Gaesser GA, Angadi SS. Cardiorespiratory fitness, body mass index and mortality: a systematic review and meta-analysis. Br J Sports Med. 2025 Feb 20;59(5):339-346. doi: 10.1136/bjsports-2024-108748. PMID 39537313
  • Wang J, Ren C, Xu S, Yuan Y, Song Y, Xie D, Wang K, Yuan L, Shen T, Xu L, Tang Y, Gao W, Zhao W. A reference equation for peak oxygen uptake for cycle ergometry in Chinese adult participants. Sci Rep. 2025 Mar 29;15(1):10876. doi: 10.1038/s41598-025-94207-7. PMID 40157952
  • Brazile TL, Levine BD, Shafer KM. Cardiopulmonary Exercise Testing. NEJM Evid. 2025 Feb;4(2):EVIDra2400390. doi: 10.1056/EVIDra2400390. Epub 2025 Jan 28. PMID 39873542
  • Kokkinos P, Kaminsky LA, Arena R, Zhang J, Myers J. A new generalized cycle ergometry equation for predicting maximal oxygen uptake: The Fitness Registry and the Importance of Exercise National Database (FRIEND). Eur J Prev Cardiol. 2018 Jul;25(10):1077-1082. doi: 10.1177/2047487318772667. Epub 2018 Apr 25. PMID 29692203
  • Kaminsky LA, Myers J, Arena R. Determining Cardiorespiratory Fitness With Precision: Compendium of Findings From the FRIEND Registry. Prog Cardiovasc Dis. 2019 Jan-Feb;62(1):76-82. doi: 10.1016/j.pcad.2018.10.003. Epub 2018 Oct 30. PMID 30385268
  • Daneshvar F, Weinreich M, Daneshvar D, Sperling M, Salmane C, Yacoub H, Gabriels J, McGinn T, Smith MC. Cardiorespiratory Fitness in Internal Medicine Residents: Are Future Physicians Becoming Deconditioned? J Grad Med Educ. 2017 Feb;9(1):97-101. doi: 10.4300/JGME-D-15-00720.1. PMID 28261402
  • de Souza E Silva CG, Kaminsky LA, Arena R, Christle JW, Araujo CGS, Lima RM, Ashley EA, Myers J. A reference equation for maximal aerobic power for treadmill and cycle ergometer exercise testing: Analysis from the FRIEND registry. Eur J Prev Cardiol. 2018 May;25(7):742-750. doi: 10.1177/2047487318763958. Epub 2018 Mar 8. PMID 29517365

Identifiers

NCT: NCT07108296 · KFKT-2025-KY-010 · KFKT-2025-KY-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗