A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Peak Oxygen Uptake [Срок оценки: On the day of enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 15 центров

• Peking Union Medical College Hospital — Пекин
• Quanzhou First Hospital Affiliated to Fujian Medical University — Quanzhou
• Guangdong Provincial People's Hospital Affiliated to Southern Medical University — Гуанчжоу
• Guangdong Provincial Hospital of Chinese Medicine — Гуанчжоу
• Jiangbin Hospital of Guangxi Zhuang Autonomous Region — Nanning
• Daqing Oilfield General Hospital — Daqing
• The Second Hospital of Harbin Medical University — Харбин
• Anyang Regional Hospital of Puyang City, Henan Province — Puyang
• … и ещё 7 центров

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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