A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population
NCT ID: NCT07108296
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
4620 participants
OBSERVATIONAL
2025-09-01
2027-03-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Chinese Age-Sex-Stratified Cardiopulmonary Function Cohort (CACSF Cohort)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Affiliated Hospital of Changchun University of Chinese Medicine
OTHER
Responsible Party
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Xiaoping Meng
Head of Cardiac Rehabilitation Department
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 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
Harbin, 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
Xiangya Second Hospital of Central South University
Changsha, Hunan, China
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shangdong, China
Tongji Hospital
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Rongjing R Ding, MD
Role: primary
Ruozhu R Dai
Role: primary
Huan H Ma, MD
Role: primary
Wei W Jiang, MD
Role: primary
Youcai Y Hu, MD
Role: primary
Zhiqing Z Fan, MD
Role: primary
Jian J Wu, MD
Role: primary
Hui H Liu, MD
Role: primary
Dongwei D Wang
Role: primary
Cuntai C Zhang, MD
Role: primary
Danyan D Xu, MD
Role: primary
Lin L Shen, MD
Role: primary
Head of Cardiac Rehabilitation Department
Role: primary
Fenling F Fan, MD
Role: primary
References
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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.
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.
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.
Brazile TL, Levine BD, Shafer KM. Cardiopulmonary Exercise Testing. NEJM Evid. 2025 Feb;4(2):EVIDra2400390. doi: 10.1056/EVIDra2400390. Epub 2025 Jan 28.
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.
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.
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.
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.
Ashikaga K, Itoh H, Maeda T, Itoh H, Ichikawa Y, Tanaka S, Ajisaka R, Koike A, Makita S, Omiya K, Kato Y, Adachi H, Nagayama M, Tajima A, Harada N, Akashi YJ; Committee on Exercise Prescription for Patients (CEPP) Members. Ventilatory efficiency during ramp exercise in relation to age and sex in a healthy Japanese population. J Cardiol. 2021 Jan;77(1):57-64. doi: 10.1016/j.jjcc.2020.07.008. Epub 2020 Aug 5.
Katzmarzyk PT, Friedenreich C, Shiroma EJ, Lee IM. Physical inactivity and non-communicable disease burden in low-income, middle-income and high-income countries. Br J Sports Med. 2022 Jan;56(2):101-106. doi: 10.1136/bjsports-2020-103640. Epub 2021 Mar 29.
Other Identifiers
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KFKT-2025-KY-010
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KFKT-2025-KY-010
Identifier Type: -
Identifier Source: org_study_id
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